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Metacam Oral Suspension

Metacam Oral Suspension
Cat » 3ml Bottle

  • Cat » 3ml Bottle £5.50
  • Cat » 15ml bottle £10.49
  • Cat » 30ml bottle £19.99
  • Dog » 10ml Bottle £3.89
  • Dog » 32ml Bottle £8.99
  • Dog » 100ml Bottle £20.99
  • Dog » 180ml Bottle £25.49
  • Horse » 100ml Bottle £41.50
  • Horse » 250ml Bottle £79.99
  • Pig » 100ml Bottle £51.49

Selection of 10 products from

£3.89 to £79.99

Description

Metacam treats arthritis and other causes of pain and inflammation, especially those affecting the musculo-skeletal system. It can also be used to relieve pain and reduce inflammation after surgical operations, or to aid treatment in certain types of infection. Metacam belongs to the group of drugs known as non-steroidal anti-inflammatory drugs and is one of the safest available for use in dogs, cats and horses. Metacam is supplied as a pleasantly flavoured liquid to be given by mouth or with food. If the dose is given directly into the mouth, this is best done after a meal. Metacam side effects are reduced through its ability to target the sites of inflammation while having much less effect than many other medications on the gut lining and kidneys.

Metacam is not advised for animals which are dehydrated, and care is needed where conditions affecting the kidneys or gut lining are suspected.

How long will a bottle of Metacam Oral Suspension last?

The following tables show how long each bottle will last in days, depending on the weight of the animal.

Dogs

Body Weight (lbs) 180ml Bottle 100ml Bottle 32ml Bottle 10ml Bottle
15 395 219 69 21
30 197 109 34 10
35 169 93 29 8
40 148 82 25 7
55 107 59 18 5
60 98 54 13 5
75 78 43 13 3
100 58 32 10 2

Cats

Body Weight (lbs) 30ml Bottle 15ml Bottle 3ml Bottle
2.5 130 65 13
5 64 32 6
10 32 16 3
15 20 10 2
20 14 7 1
25 12 6 1
30 10 5 1

Metacam 15 mg/ml Oral Suspension for Pigs

Species: Pigs Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Other NSAIDs, Locomotor (including navicular and osteoarthritis) Active ingredient: Meloxicam Product:Metacam 15 mg/ml oral suspension for pigs Product index: Metacam 15 mg/ml oral suspension for pigs Pig - meat: 5 days

Presentation

Yellowish viscous oral suspension with a green tinge. One ml contains meloxicam 15 mg as active substance and Sodium benzoate 1.5 mg.

Uses

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-Agalactia syndrome MMA) with appropriate antibiotic therapy.

Dosage and administration

Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam can be given after 24 hours. In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam 20 mg/ml solution for injection is recommended. To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to feeding, or directly into the mouth. The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale. Shake well before use. After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

Contra-indications, warnings, etc

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Special precautions for use in animals

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral rehydration, as there may be a potential risk of renal toxicity. Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents. Can be used during pregnancy and lactation. In case of overdose symptomatic treatment should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Withdrawal period

Meat and offal: 5 days.

Pharmaceutical precautions

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf-life after first opening of the immediate packaging: 6 months. Keep out of sight and reach of children. For animal treatment only. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Legal category: POM-V

Packaging quantities

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter, a tamper proof child resistant closure and a measuring syringe. Not all pack sizes may be marketed.

Further information

Pharmacodynamic properties

Meloxicam is a Non-Steroidal Anti-Inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in pigs. Pharmacokinetic particulars Absorption After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 µg/ml was reached after 2 hours. Distribution More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat. Metabolism Meloxicam is predominantly found in plasma. Bile and urine contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. Elimination After oral administration the mean plasma elimination half-life is approximately 2.3 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim/Rhein, Germany

Marketing Authorisation Number

EU/2/97/004/041 100 ml EU/2/97/004/042 250 ml

Significant changes

GTIN

GTIN description:Metacam 15 mg/ml oral suspension for pigs - 100ml GTIN:5012917010374

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Medication Datasheets

Dog » 100ml Bottle

Metacam 1.5 mg/ml oral suspension for dogs

Presentation

Yellowish viscous oral suspension with a green tinge. One ml contains 1.5 mg meloxicam as active substance (equivalent to 0.05 mg per drop) and 1.5 mg sodium benzoate (equivalent to 0.05 mg per drop).

Uses

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Dosage and administration

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing. Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:

Initial dose: 4 drops /kg body weight

Maintenance dose: 2 drops /kg body weight.

Dosing procedure using the measuring syringe:

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent. Avoid introduction of contamination during use.

Contra-indications, warnings, etc

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 0.5 mg/ml oral suspension for cats should be used.

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the

following convention:

• very common (more than 1 in 10 animals treated displaying adverse reactions)

• common (more than 1 but less than 10 animals in 100 animals treated)

• uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• rare (more than 1 but less than 10 animals in 10,000 animals treated)

• very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

In case of overdose, symptomatic treatment should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to Non Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Pharmaceutical precautions

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate packaging: 6 months.

Keep out of the sight and reach of children. For animal treatment only.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Packaging quantities

Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a tamper proof child resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene measuring syringe. Not all pack sizes may be marketed.

Further information

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic particulars

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing Authorisation Number

EU/2/97/004/003 : 10 ml

EU/2/97/004/004 : 32 ml

EU/2/97/004/005 : 100 ml

EU/2/97/004/029 : 180 ml

Dog » 32ml Bottle

Metacam 1.5 mg/ml oral suspension for dogs

Presentation

Yellowish viscous oral suspension with a green tinge. One ml contains 1.5 mg meloxicam as active substance (equivalent to 0.05 mg per drop) and 1.5 mg sodium benzoate (equivalent to 0.05 mg per drop).

Uses

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Dosage and administration

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing. Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:

Initial dose: 4 drops /kg body weight

Maintenance dose: 2 drops /kg body weight.

Dosing procedure using the measuring syringe:

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent. Avoid introduction of contamination during use.

Contra-indications, warnings, etc

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 0.5 mg/ml oral suspension for cats should be used.

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the

following convention:

• very common (more than 1 in 10 animals treated displaying adverse reactions)

• common (more than 1 but less than 10 animals in 100 animals treated)

• uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• rare (more than 1 but less than 10 animals in 10,000 animals treated)

• very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

In case of overdose, symptomatic treatment should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to Non Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Pharmaceutical precautions

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate packaging: 6 months.

Keep out of the sight and reach of children. For animal treatment only.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Packaging quantities

Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a tamper proof child resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene measuring syringe. Not all pack sizes may be marketed.

Further information

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic particulars

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing Authorisation Number

EU/2/97/004/003 : 10 ml

EU/2/97/004/004 : 32 ml

EU/2/97/004/005 : 100 ml

EU/2/97/004/029 : 180 ml

Dog » 10ml Bottle

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for cattle and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (calves and young cattle) and pigs

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For the relief of post-operative pain associated with minor soft tissue surgery such as castration.

4.3 Contraindications

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Do not use in pigs less than 2 days old.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

Treatment of piglets with Metacam before castration reduces post-operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed. To obtain the best
possible pain relieving effect post-surgery Metacam should be administered 30 minutes before surgical
intervention.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient
swelling at the injection site following subcutaneous administration was observed in less than 10 % of the
cattle treated in clinical studies.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body
weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body
weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate
dosing device and careful estimation of body weight.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days
Pigs: Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit
production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 g/ml were reached after
7.7 hours in young cattle.
Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 g/ml was
reached within 1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately
2.5 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via
faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a
rubber stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/035 1 x 20 ml
EU/2/97/004/037 1 x 50 ml
EU/2/97/004/001 1 x 100 ml
EU/2/97/004/036 12 x 20 ml
EU/2/97/004/038 12 x 50 ml
EU/2/97/004/010 12 x 100 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 4 drops/kg body weight
Maintenance dose: 2 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a tamper-
proof child-resistant closure. Each bottle is packed in a cardboard box and is equipped with a
polypropylene measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/003 10 ml
EU/2/97/004/004 32 ml
EU/2/97/004/005 100 ml
EU/2/97/004/029 180 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of
post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity. During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should
avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have
been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been
reported. These side effects occur generally within the first treatment week and are in most cases transient
and disappear following termination of the treatment but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or
subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and
NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Dogs:
Musculo-skeletal disorders:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body
weight). Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for
dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight,
24 hours after administration of the injection.

Reduction of post-operative pain (over a period of 24 hours):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e.
0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats:
Reduction of post-operative pain:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 0.73 g/ml in dogs and 1.1 g/ml in cats were reached approximately 2.5 hours and
1.5 hours post administration, respectively.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range in dogs and cats. More than 97 % of meloxicam is bound to plasma proteins. The
volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an
acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.

In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Five major metabolites were detected all

having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. As for other species investigated, the main pathway of
meloxicam biotransformation in cat is oxidation.

Elimination
In dogs, meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered
dose is eliminated via faeces and the remainder via urine.

In cats, meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/006 10 ml
EU/2/97/004/011 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 20 mg/ml solution for injection for cattle, pigs and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 20 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, pigs and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia
syndrome) with appropriate antibiotic therapy.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

See also section 4.7.
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated;
only a slight transient swelling at the injection site following subcutaneous administration was observed
in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals treated in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle and pigs: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares.
See also section 4.3.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body
weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of
meloxicam can be given after 24 hours.

Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body
weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a
dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, symptomatic treatment should be initiated.

4.11 Withdrawal period

Cattle: Meat and offal: 15 days; Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days.
Not authorised to use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves, lactating cows and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 g/ml was reached after
1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. The
metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In pigs, after intramuscular administration the mean plasma elimination half-life is approximately
2.5 hours.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials):
3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20 ml, 50 ml or
100 ml.

Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/027 1 x 20 ml
EU/2/97/004/007 1 x 50 ml
EU/2/97/004/008 1 x 100 ml
EU/2/97/004/031 1 x 250 ml
EU/2/97/004/028 12 x 20 ml
EU/2/97/004/014 12 x 50 ml
EU/2/97/004/015 12 x 100 ml
EU/2/97/004/032 6 x 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 15 mg

Excipient:
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Horses

4.2 Indications for use, specifying the target species

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in
horses.

4.3 Contraindications

Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal
toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials
(slight urticaria, diarrhoea). Symptoms were reversible.
In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic
effects. However, no data have been generated in horses. Therefore the use in this species is not
recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body
weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small
quantity of food, prior to feeding.

The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 3 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli
endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
When the product is used according to the recommended dosage regime the oral bioavailability is
approximately 98 %. Maximal plasma concentrations are obtained after approximately 23 hours. The
accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution
Approximately 98 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively
there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-
metabolites and the oxalyl-metabolite. The metabolism in horses was not investigated. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter
and a tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/009 100 ml
EU/2/97/004/030 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.02 mg per drop)

Excipients:
Sodium benzoate 1.5 mg (equivalent to 0.06 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats due to the different dosing devices. In cats, Metacam
0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 10 drops/kg body weight
Maintenance dose: 5 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 15 ml or 30 ml with a polyethylene dropper and a tamper-proof child-
resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene
measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/012 15 ml
EU/2/97/004/013 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substance:
Meloxicam 1 mg
Meloxicam 2.5 mg

Excipients:
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablets.
Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or
"M25" on one side.
The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be
given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.

Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance
dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the
dog. Metacam chewable tablets can be administered with or without food, are flavoured and are taken by
most dogs voluntarily.

Dose scheme for the maintenance dose:

Number of chewable tablets
Body weight (kg) mg/kg
1 mg 2.5 mg
4.07.0 0.130.1
7.110.0 1 0.140.1
10.115.0 1 0.150.1
15.120.0 2 0.130.1
20.125.0 1 0.120.1
25.135.0 1 0.150.1
35.150.0 2 0.140.1

The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For
dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days if
no clinical improvement is apparent.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated in faeces and the remainder in urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium citrate dihydrate
Starch, pregelatinized
Iron oxide brown
Iron oxide yellow
Cellulose, microcrystalline
Meat Dry Flavour
Silica, colloidal anhydrous
Magnesium stearate

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard boxes containing 7, 84 or 252 tablets in Alu/Alu child-resistant blisters.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

Metacam 1 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/043 7 tablets
EU/2/97/004/044 84 tablets
EU/2/97/004/045 252 tablets

Metacam 2.5 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/046 7 tablets
EU/2/97/004/047 84 tablets
EU/2/97/004/048 252 tablets

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.017 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Cats and guinea pigs

4.2 Indications for use, specifying the target species

Cats:
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Guinea pigs:
Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male
castration.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
Do not use in guinea pigs less than 4 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

Post-operative use in cats and guinea pigs:
In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders in cats:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated
liver enzymes were reported in very rare cases.

These side effects are in most cases transient and disappear following termination of the treatment but in
very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided.

In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for
injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Cats:
Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours
later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg
meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg
meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be
discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration
Dosing procedure using the drop dispenser of the bottle:
Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight
Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculo-
skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the
treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be
required.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight.
Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the
package can be used.
Particular care should be taken with regard to the accuracy of dosing.
The recommended dose should not be exceeded.

Guinea pigs:
Dosage
Post-operative pain associated with soft tissue surgery:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery).
Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg
meloxicam/kg body weight on day 2 to day 3 (post-surgery).

The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The
safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.

Route and method of administration
The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml
scale and 0.01 ml increments.

Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised
to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw
up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe
directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next
use.

Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs.

Advice on correct administration
Shake well before use.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at
relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more
frequent. In case of overdose symptomatic treatment should be initiated.

In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of
0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of
doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Cats:
Absorption
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately
3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown

to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

Guinea pigs:
No data available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:
3 ml bottle: 2 years
10 ml, 15 ml and 30 ml bottle: 3 years.

Shelf life after first opening the immediate packaging:
3 ml bottle: 14 days
10 ml, 15 ml and 30 ml bottle: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper-proof child-resistant
closure.
Polyethylene bottle containing 10 ml, 15 ml or 30 ml with a polyethylene dropper and a tamper-proof
child-resistant closure.
Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe
which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/034 3 ml
EU/2/97/004/033 10 ml
EU/2/97/004/026 15 ml
EU/2/97/004/049 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 2 mg/ml solution for injection for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 2 mg

Excipients:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cats

4.2 Indications for use, specifying the target species

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive cat, as there is a potential risk of renal
toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
In case additional pain relief is required, multimodal pain therapy should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported and in very rare cases gastrointestinal
ulceration and elevated liver enzymes.

These adverse reactions are in most cases transient and disappear following termination of the treatment
but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged
animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be
excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.
To continue treatment for up to five days, this initial dose may be followed 24 hours later by
administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.

Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has
also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation.
This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible

e.g. feral cats. In this case do not use oral follow up treatment.

Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 1.1 g/ml were reached approximately 1.5 hours post administration.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. More than 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.09 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown
to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/039 10 ml
EU/2/97/004/040 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998

Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance(s):
Meloxicam 15 mg

Excipient(s):
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-
Agalactia syndrome MMA) with appropriate antibiotic therapy.

4.3 Contraindications

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders,
or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in
combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam
can be given after 24 hours.
In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam
20 mg/ml solution for injection is recommended.

To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to
feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli

endotoxin administration in pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 g/ml was reached after 2 hours.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. Bile and urine contain only traces of the parent compound.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
After oral administration the mean plasma elimination half-life is approximately 2.3 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter, a
tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/041 100 ml
EU/2/97/004/042 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 40 mg/ml solution for injection for cattle and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 40 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

Do not use in pregnant or lactating mares (see section 4.7).
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam

alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other
prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product
should not be administered by pregnant women or women attempting to conceive.

4.6 Adverse reactions (frequency and seriousness)

In cattle, a slight transient painless swelling at the injection site was observed in most animals in
laboratory studies. This local reaction resolved within 8 hours following subcutaneous administration.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares (see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Horses:
Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 1.5 ml/100 kg body
weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dose
of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days; milk: 5 days.
Horses: Meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves and lactating cows.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an
alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive. The metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Pack sizes of 1 or 12 colourless glass injection vial(s) each containing 50 ml or 100 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

  1. MARKETING AUTHORISATION NUMBER(S)

EU/2/97/004/050053

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Horse » 100ml Bottle

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for cattle and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (calves and young cattle) and pigs

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For the relief of post-operative pain associated with minor soft tissue surgery such as castration.

4.3 Contraindications

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Do not use in pigs less than 2 days old.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

Treatment of piglets with Metacam before castration reduces post-operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed. To obtain the best
possible pain relieving effect post-surgery Metacam should be administered 30 minutes before surgical
intervention.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient
swelling at the injection site following subcutaneous administration was observed in less than 10 % of the
cattle treated in clinical studies.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body
weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body
weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate
dosing device and careful estimation of body weight.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days
Pigs: Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit
production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 g/ml were reached after
7.7 hours in young cattle.
Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 g/ml was
reached within 1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately
2.5 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via
faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a
rubber stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/035 1 x 20 ml
EU/2/97/004/037 1 x 50 ml
EU/2/97/004/001 1 x 100 ml
EU/2/97/004/036 12 x 20 ml
EU/2/97/004/038 12 x 50 ml
EU/2/97/004/010 12 x 100 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 4 drops/kg body weight
Maintenance dose: 2 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a tamper-
proof child-resistant closure. Each bottle is packed in a cardboard box and is equipped with a
polypropylene measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/003 10 ml
EU/2/97/004/004 32 ml
EU/2/97/004/005 100 ml
EU/2/97/004/029 180 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of
post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity. During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should
avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have
been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been
reported. These side effects occur generally within the first treatment week and are in most cases transient
and disappear following termination of the treatment but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or
subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and
NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Dogs:
Musculo-skeletal disorders:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body
weight). Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for
dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight,
24 hours after administration of the injection.

Reduction of post-operative pain (over a period of 24 hours):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e.
0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats:
Reduction of post-operative pain:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 0.73 g/ml in dogs and 1.1 g/ml in cats were reached approximately 2.5 hours and
1.5 hours post administration, respectively.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range in dogs and cats. More than 97 % of meloxicam is bound to plasma proteins. The
volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an
acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.

In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Five major metabolites were detected all

having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. As for other species investigated, the main pathway of
meloxicam biotransformation in cat is oxidation.

Elimination
In dogs, meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered
dose is eliminated via faeces and the remainder via urine.

In cats, meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/006 10 ml
EU/2/97/004/011 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 20 mg/ml solution for injection for cattle, pigs and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 20 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, pigs and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia
syndrome) with appropriate antibiotic therapy.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

See also section 4.7.
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated;
only a slight transient swelling at the injection site following subcutaneous administration was observed
in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals treated in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle and pigs: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares.
See also section 4.3.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body
weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of
meloxicam can be given after 24 hours.

Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body
weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a
dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, symptomatic treatment should be initiated.

4.11 Withdrawal period

Cattle: Meat and offal: 15 days; Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days.
Not authorised to use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves, lactating cows and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 g/ml was reached after
1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. The
metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In pigs, after intramuscular administration the mean plasma elimination half-life is approximately
2.5 hours.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials):
3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20 ml, 50 ml or
100 ml.

Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/027 1 x 20 ml
EU/2/97/004/007 1 x 50 ml
EU/2/97/004/008 1 x 100 ml
EU/2/97/004/031 1 x 250 ml
EU/2/97/004/028 12 x 20 ml
EU/2/97/004/014 12 x 50 ml
EU/2/97/004/015 12 x 100 ml
EU/2/97/004/032 6 x 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 15 mg

Excipient:
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Horses

4.2 Indications for use, specifying the target species

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in
horses.

4.3 Contraindications

Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal
toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials
(slight urticaria, diarrhoea). Symptoms were reversible.
In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic
effects. However, no data have been generated in horses. Therefore the use in this species is not
recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body
weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small
quantity of food, prior to feeding.

The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 3 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli
endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
When the product is used according to the recommended dosage regime the oral bioavailability is
approximately 98 %. Maximal plasma concentrations are obtained after approximately 23 hours. The
accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution
Approximately 98 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively
there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-
metabolites and the oxalyl-metabolite. The metabolism in horses was not investigated. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter
and a tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/009 100 ml
EU/2/97/004/030 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.02 mg per drop)

Excipients:
Sodium benzoate 1.5 mg (equivalent to 0.06 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats due to the different dosing devices. In cats, Metacam
0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 10 drops/kg body weight
Maintenance dose: 5 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 15 ml or 30 ml with a polyethylene dropper and a tamper-proof child-
resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene
measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/012 15 ml
EU/2/97/004/013 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substance:
Meloxicam 1 mg
Meloxicam 2.5 mg

Excipients:
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablets.
Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or
"M25" on one side.
The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be
given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.

Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance
dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the
dog. Metacam chewable tablets can be administered with or without food, are flavoured and are taken by
most dogs voluntarily.

Dose scheme for the maintenance dose:

Number of chewable tablets
Body weight (kg) mg/kg
1 mg 2.5 mg
4.07.0 0.130.1
7.110.0 1 0.140.1
10.115.0 1 0.150.1
15.120.0 2 0.130.1
20.125.0 1 0.120.1
25.135.0 1 0.150.1
35.150.0 2 0.140.1

The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For
dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days if
no clinical improvement is apparent.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated in faeces and the remainder in urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium citrate dihydrate
Starch, pregelatinized
Iron oxide brown
Iron oxide yellow
Cellulose, microcrystalline
Meat Dry Flavour
Silica, colloidal anhydrous
Magnesium stearate

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard boxes containing 7, 84 or 252 tablets in Alu/Alu child-resistant blisters.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

Metacam 1 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/043 7 tablets
EU/2/97/004/044 84 tablets
EU/2/97/004/045 252 tablets

Metacam 2.5 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/046 7 tablets
EU/2/97/004/047 84 tablets
EU/2/97/004/048 252 tablets

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.017 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Cats and guinea pigs

4.2 Indications for use, specifying the target species

Cats:
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Guinea pigs:
Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male
castration.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
Do not use in guinea pigs less than 4 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

Post-operative use in cats and guinea pigs:
In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders in cats:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated
liver enzymes were reported in very rare cases.

These side effects are in most cases transient and disappear following termination of the treatment but in
very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided.

In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for
injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Cats:
Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours
later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg
meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg
meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be
discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration
Dosing procedure using the drop dispenser of the bottle:
Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight
Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculo-
skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the
treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be
required.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight.
Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the
package can be used.
Particular care should be taken with regard to the accuracy of dosing.
The recommended dose should not be exceeded.

Guinea pigs:
Dosage
Post-operative pain associated with soft tissue surgery:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery).
Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg
meloxicam/kg body weight on day 2 to day 3 (post-surgery).

The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The
safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.

Route and method of administration
The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml
scale and 0.01 ml increments.

Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised
to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw
up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe
directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next
use.

Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs.

Advice on correct administration
Shake well before use.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at
relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more
frequent. In case of overdose symptomatic treatment should be initiated.

In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of
0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of
doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Cats:
Absorption
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately
3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown

to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

Guinea pigs:
No data available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:
3 ml bottle: 2 years
10 ml, 15 ml and 30 ml bottle: 3 years.

Shelf life after first opening the immediate packaging:
3 ml bottle: 14 days
10 ml, 15 ml and 30 ml bottle: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper-proof child-resistant
closure.
Polyethylene bottle containing 10 ml, 15 ml or 30 ml with a polyethylene dropper and a tamper-proof
child-resistant closure.
Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe
which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/034 3 ml
EU/2/97/004/033 10 ml
EU/2/97/004/026 15 ml
EU/2/97/004/049 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 2 mg/ml solution for injection for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 2 mg

Excipients:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cats

4.2 Indications for use, specifying the target species

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive cat, as there is a potential risk of renal
toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
In case additional pain relief is required, multimodal pain therapy should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported and in very rare cases gastrointestinal
ulceration and elevated liver enzymes.

These adverse reactions are in most cases transient and disappear following termination of the treatment
but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged
animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be
excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.
To continue treatment for up to five days, this initial dose may be followed 24 hours later by
administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.

Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has
also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation.
This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible

e.g. feral cats. In this case do not use oral follow up treatment.

Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 1.1 g/ml were reached approximately 1.5 hours post administration.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. More than 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.09 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown
to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/039 10 ml
EU/2/97/004/040 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998

Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance(s):
Meloxicam 15 mg

Excipient(s):
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-
Agalactia syndrome MMA) with appropriate antibiotic therapy.

4.3 Contraindications

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders,
or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in
combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam
can be given after 24 hours.
In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam
20 mg/ml solution for injection is recommended.

To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to
feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli

endotoxin administration in pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 g/ml was reached after 2 hours.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. Bile and urine contain only traces of the parent compound.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
After oral administration the mean plasma elimination half-life is approximately 2.3 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter, a
tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/041 100 ml
EU/2/97/004/042 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 40 mg/ml solution for injection for cattle and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 40 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

Do not use in pregnant or lactating mares (see section 4.7).
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam

alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other
prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product
should not be administered by pregnant women or women attempting to conceive.

4.6 Adverse reactions (frequency and seriousness)

In cattle, a slight transient painless swelling at the injection site was observed in most animals in
laboratory studies. This local reaction resolved within 8 hours following subcutaneous administration.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares (see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Horses:
Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 1.5 ml/100 kg body
weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dose
of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days; milk: 5 days.
Horses: Meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves and lactating cows.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an
alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive. The metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Pack sizes of 1 or 12 colourless glass injection vial(s) each containing 50 ml or 100 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

  1. MARKETING AUTHORISATION NUMBER(S)

EU/2/97/004/050053

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Cat » 15ml bottle

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

Presentation

Yellowish viscous oral suspension with a green tinge. One ml contains 0.5 mg meloxicam as active ingredient (equivalent to 0.017 mg per drop) and 1.5 mg sodium benzoate (equivalent to 0.05 mg per drop).

Uses

Cats

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery. For alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Guinea pigs:

Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.

Dosage and administration

Cats:

Dosage

Post-operative pain and inflammation following surgical procedures:

After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration

Dosing procedure using the drop dispenser of the bottle:

Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight

Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight

Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.

Dosing procedure using the measuring syringe:

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.

To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using the drop dispenser of the bottle for cats of any body weight. Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the package can be used.

Particular care should be taken with regard to the accuracy of dosing.

The recommended dose should not be exceeded.

Guinea pigs:

Dosage

Post-operative pain associated with soft tissue surgery:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery). Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg meloxicam/kg body weight on day 2 to day 3 (post-surgery).

The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.

Route and method of administration

The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.

Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight

Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next use.

Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs.

Advice on correct administration

Shake well before use.

Avoid introduction of contamination during use.

Contra-indications, warnings, etc

Contraindications

Do not use in pregnant or lactating animals.

Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cats less than 6 weeks of age.

Do not use in guinea pigs less than 4 weeks of age.

Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

Post-operative use in cats and guinea pigs:

In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders in cats:

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases.

These side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reactions)

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Overdose (symptoms, emergency procedures, antidotes), if necessary

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.

In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See section 4.3).

Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided.

In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Pharmaceutical precautions

Shelf life of the veterinary medicinal product as packaged for sale:

3 ml bottle: 2 years

10 ml, 15 ml and 30 ml bottle: 3 years.

Shelf life after first opening the immediate packaging:

3 ml bottle: 14 days

10 ml, 15 ml and 30 ml bottle: 6 months.

This veterinary medicinal product does not require any special storage conditions.

Keep out of the sight and reach of children. For animal treatment only.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Packaging quantities

Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper-proof child-resistant closure.

Polyethylene bottle containing 10 ml, 15 ml or 30 ml with a polyethylene dropper and a tamper-proof child-resistant closure.

Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.

Further information

Pharmacodynamic properties

Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic properties

Cats:

Absorption

If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in the faeces (49% as unchanged meloxicam, 30% as metabolites).

Guinea pigs:

No data available.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing Authorisation Number

EU/2/97/004/034 – 3 ml

EU/2/97/004/033 – 10 ml

EU/2/97/004/026 – 15 ml

EU/2/97/004/049 – 30 ml

Dog » 180ml Bottle

Metacam 1.5 mg/ml oral suspension for dogs

Presentation

Yellowish viscous oral suspension with a green tinge. One ml contains 1.5 mg meloxicam as active substance (equivalent to 0.05 mg per drop) and 1.5 mg sodium benzoate (equivalent to 0.05 mg per drop).

Uses

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Dosage and administration

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of Metacam can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing. Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:

Initial dose: 4 drops /kg body weight

Maintenance dose: 2 drops /kg body weight.

Dosing procedure using the measuring syringe:

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent. Avoid introduction of contamination during use.

Contra-indications, warnings, etc

Do not use in pregnant or lactating animals.

Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Metacam 0.5 mg/ml oral suspension for cats should be used.

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the

following convention:

• very common (more than 1 in 10 animals treated displaying adverse reactions)

• common (more than 1 but less than 10 animals in 100 animals treated)

• uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• rare (more than 1 but less than 10 animals in 10,000 animals treated)

• very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

In case of overdose, symptomatic treatment should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to Non Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Pharmaceutical precautions

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate packaging: 6 months.

Keep out of the sight and reach of children. For animal treatment only.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Packaging quantities

Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a tamper proof child resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene measuring syringe. Not all pack sizes may be marketed.

Further information

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic particulars

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing Authorisation Number

EU/2/97/004/003 : 10 ml

EU/2/97/004/004 : 32 ml

EU/2/97/004/005 : 100 ml

EU/2/97/004/029 : 180 ml

Horse » 250ml Bottle

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for cattle and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (calves and young cattle) and pigs

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For the relief of post-operative pain associated with minor soft tissue surgery such as castration.

4.3 Contraindications

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Do not use in pigs less than 2 days old.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

Treatment of piglets with Metacam before castration reduces post-operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed. To obtain the best
possible pain relieving effect post-surgery Metacam should be administered 30 minutes before surgical
intervention.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient
swelling at the injection site following subcutaneous administration was observed in less than 10 % of the
cattle treated in clinical studies.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body
weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body
weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate
dosing device and careful estimation of body weight.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days
Pigs: Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit
production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 g/ml were reached after
7.7 hours in young cattle.
Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 g/ml was
reached within 1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately
2.5 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via
faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a
rubber stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/035 1 x 20 ml
EU/2/97/004/037 1 x 50 ml
EU/2/97/004/001 1 x 100 ml
EU/2/97/004/036 12 x 20 ml
EU/2/97/004/038 12 x 50 ml
EU/2/97/004/010 12 x 100 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 4 drops/kg body weight
Maintenance dose: 2 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a tamper-
proof child-resistant closure. Each bottle is packed in a cardboard box and is equipped with a
polypropylene measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/003 10 ml
EU/2/97/004/004 32 ml
EU/2/97/004/005 100 ml
EU/2/97/004/029 180 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of
post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity. During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should
avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have
been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been
reported. These side effects occur generally within the first treatment week and are in most cases transient
and disappear following termination of the treatment but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or
subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and
NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Dogs:
Musculo-skeletal disorders:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body
weight). Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for
dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight,
24 hours after administration of the injection.

Reduction of post-operative pain (over a period of 24 hours):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e.
0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats:
Reduction of post-operative pain:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 0.73 g/ml in dogs and 1.1 g/ml in cats were reached approximately 2.5 hours and
1.5 hours post administration, respectively.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range in dogs and cats. More than 97 % of meloxicam is bound to plasma proteins. The
volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an
acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.

In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Five major metabolites were detected all

having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. As for other species investigated, the main pathway of
meloxicam biotransformation in cat is oxidation.

Elimination
In dogs, meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered
dose is eliminated via faeces and the remainder via urine.

In cats, meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/006 10 ml
EU/2/97/004/011 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 20 mg/ml solution for injection for cattle, pigs and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 20 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, pigs and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia
syndrome) with appropriate antibiotic therapy.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

See also section 4.7.
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated;
only a slight transient swelling at the injection site following subcutaneous administration was observed
in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals treated in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle and pigs: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares.
See also section 4.3.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body
weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of
meloxicam can be given after 24 hours.

Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body
weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a
dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, symptomatic treatment should be initiated.

4.11 Withdrawal period

Cattle: Meat and offal: 15 days; Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days.
Not authorised to use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves, lactating cows and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 g/ml was reached after
1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. The
metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In pigs, after intramuscular administration the mean plasma elimination half-life is approximately
2.5 hours.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials):
3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20 ml, 50 ml or
100 ml.

Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/027 1 x 20 ml
EU/2/97/004/007 1 x 50 ml
EU/2/97/004/008 1 x 100 ml
EU/2/97/004/031 1 x 250 ml
EU/2/97/004/028 12 x 20 ml
EU/2/97/004/014 12 x 50 ml
EU/2/97/004/015 12 x 100 ml
EU/2/97/004/032 6 x 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 15 mg

Excipient:
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Horses

4.2 Indications for use, specifying the target species

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in
horses.

4.3 Contraindications

Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal
toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials
(slight urticaria, diarrhoea). Symptoms were reversible.
In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic
effects. However, no data have been generated in horses. Therefore the use in this species is not
recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body
weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small
quantity of food, prior to feeding.

The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 3 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli
endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
When the product is used according to the recommended dosage regime the oral bioavailability is
approximately 98 %. Maximal plasma concentrations are obtained after approximately 23 hours. The
accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution
Approximately 98 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively
there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-
metabolites and the oxalyl-metabolite. The metabolism in horses was not investigated. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter
and a tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/009 100 ml
EU/2/97/004/030 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.02 mg per drop)

Excipients:
Sodium benzoate 1.5 mg (equivalent to 0.06 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats due to the different dosing devices. In cats, Metacam
0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 10 drops/kg body weight
Maintenance dose: 5 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 15 ml or 30 ml with a polyethylene dropper and a tamper-proof child-
resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene
measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/012 15 ml
EU/2/97/004/013 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substance:
Meloxicam 1 mg
Meloxicam 2.5 mg

Excipients:
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablets.
Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or
"M25" on one side.
The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be
given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.

Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance
dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the
dog. Metacam chewable tablets can be administered with or without food, are flavoured and are taken by
most dogs voluntarily.

Dose scheme for the maintenance dose:

Number of chewable tablets
Body weight (kg) mg/kg
1 mg 2.5 mg
4.07.0 0.130.1
7.110.0 1 0.140.1
10.115.0 1 0.150.1
15.120.0 2 0.130.1
20.125.0 1 0.120.1
25.135.0 1 0.150.1
35.150.0 2 0.140.1

The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For
dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days if
no clinical improvement is apparent.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated in faeces and the remainder in urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium citrate dihydrate
Starch, pregelatinized
Iron oxide brown
Iron oxide yellow
Cellulose, microcrystalline
Meat Dry Flavour
Silica, colloidal anhydrous
Magnesium stearate

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard boxes containing 7, 84 or 252 tablets in Alu/Alu child-resistant blisters.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

Metacam 1 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/043 7 tablets
EU/2/97/004/044 84 tablets
EU/2/97/004/045 252 tablets

Metacam 2.5 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/046 7 tablets
EU/2/97/004/047 84 tablets
EU/2/97/004/048 252 tablets

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.017 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Cats and guinea pigs

4.2 Indications for use, specifying the target species

Cats:
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Guinea pigs:
Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male
castration.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
Do not use in guinea pigs less than 4 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

Post-operative use in cats and guinea pigs:
In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders in cats:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated
liver enzymes were reported in very rare cases.

These side effects are in most cases transient and disappear following termination of the treatment but in
very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided.

In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for
injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Cats:
Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours
later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg
meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg
meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be
discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration
Dosing procedure using the drop dispenser of the bottle:
Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight
Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculo-
skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the
treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be
required.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight.
Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the
package can be used.
Particular care should be taken with regard to the accuracy of dosing.
The recommended dose should not be exceeded.

Guinea pigs:
Dosage
Post-operative pain associated with soft tissue surgery:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery).
Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg
meloxicam/kg body weight on day 2 to day 3 (post-surgery).

The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The
safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.

Route and method of administration
The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml
scale and 0.01 ml increments.

Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised
to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw
up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe
directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next
use.

Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs.

Advice on correct administration
Shake well before use.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at
relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more
frequent. In case of overdose symptomatic treatment should be initiated.

In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of
0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of
doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Cats:
Absorption
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately
3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown

to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

Guinea pigs:
No data available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:
3 ml bottle: 2 years
10 ml, 15 ml and 30 ml bottle: 3 years.

Shelf life after first opening the immediate packaging:
3 ml bottle: 14 days
10 ml, 15 ml and 30 ml bottle: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper-proof child-resistant
closure.
Polyethylene bottle containing 10 ml, 15 ml or 30 ml with a polyethylene dropper and a tamper-proof
child-resistant closure.
Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe
which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/034 3 ml
EU/2/97/004/033 10 ml
EU/2/97/004/026 15 ml
EU/2/97/004/049 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 2 mg/ml solution for injection for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 2 mg

Excipients:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cats

4.2 Indications for use, specifying the target species

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive cat, as there is a potential risk of renal
toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
In case additional pain relief is required, multimodal pain therapy should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported and in very rare cases gastrointestinal
ulceration and elevated liver enzymes.

These adverse reactions are in most cases transient and disappear following termination of the treatment
but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged
animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be
excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.
To continue treatment for up to five days, this initial dose may be followed 24 hours later by
administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.

Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has
also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation.
This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible

e.g. feral cats. In this case do not use oral follow up treatment.

Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 1.1 g/ml were reached approximately 1.5 hours post administration.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. More than 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.09 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown
to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/039 10 ml
EU/2/97/004/040 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998

Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance(s):
Meloxicam 15 mg

Excipient(s):
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-
Agalactia syndrome MMA) with appropriate antibiotic therapy.

4.3 Contraindications

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders,
or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in
combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam
can be given after 24 hours.
In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam
20 mg/ml solution for injection is recommended.

To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to
feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli

endotoxin administration in pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 g/ml was reached after 2 hours.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. Bile and urine contain only traces of the parent compound.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
After oral administration the mean plasma elimination half-life is approximately 2.3 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter, a
tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/041 100 ml
EU/2/97/004/042 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 40 mg/ml solution for injection for cattle and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 40 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

Do not use in pregnant or lactating mares (see section 4.7).
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam

alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other
prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product
should not be administered by pregnant women or women attempting to conceive.

4.6 Adverse reactions (frequency and seriousness)

In cattle, a slight transient painless swelling at the injection site was observed in most animals in
laboratory studies. This local reaction resolved within 8 hours following subcutaneous administration.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares (see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Horses:
Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 1.5 ml/100 kg body
weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dose
of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days; milk: 5 days.
Horses: Meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves and lactating cows.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an
alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive. The metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Pack sizes of 1 or 12 colourless glass injection vial(s) each containing 50 ml or 100 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

  1. MARKETING AUTHORISATION NUMBER(S)

EU/2/97/004/050053

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Cat » 3ml Bottle

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for cattle and pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle (calves and young cattle) and pigs

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For the relief of post-operative pain associated with minor soft tissue surgery such as castration.

4.3 Contraindications

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.
Do not use in pigs less than 2 days old.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

Treatment of piglets with Metacam before castration reduces post-operative pain. To obtain pain relief
during surgery co-medication with an appropriate anaesthetic/sedative is needed. To obtain the best
possible pain relieving effect post-surgery Metacam should be administered 30 minutes before surgical
intervention.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient
swelling at the injection site following subcutaneous administration was observed in less than 10 % of the
cattle treated in clinical studies.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body
weight). If required, a second administration of meloxicam can be given after 24 hours.

Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body
weight) before surgery.

Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate
dosing device and careful estimation of body weight.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days
Pigs: Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic properties. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit
production of thromboxane B2 induced by E. coli endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 g/ml were reached after
7.7 hours in young cattle.
Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 g/ml was
reached within 1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a half-life of 26 hours after subcutaneous injection in young cattle.
In pigs, after intramuscular administration, the mean plasma elimination half-life is approximately
2.5 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via
faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with 1 or 12 colourless glass injection vial(s) of 20 ml, 50 ml or 100 ml, closed with a
rubber stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/035 1 x 20 ml
EU/2/97/004/037 1 x 50 ml
EU/2/97/004/001 1 x 100 ml
EU/2/97/004/036 12 x 20 ml
EU/2/97/004/038 12 x 50 ml
EU/2/97/004/010 12 x 100 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 1.5 mg (equivalent to 0.05 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use. To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 4 drops/kg body weight
Maintenance dose: 2 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 10 ml, 32 ml, 100 ml or 180 ml with a polyethylene dropper and a tamper-
proof child-resistant closure. Each bottle is packed in a cardboard box and is equipped with a
polypropylene measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/003 10 ml
EU/2/97/004/004 32 ml
EU/2/97/004/005 100 ml
EU/2/97/004/029 180 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 5 mg/ml solution for injection for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 5 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

Dogs:
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of
post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity. During anaesthesia, monitoring and fluid therapy should be considered as standard practice.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should
avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have
been reported.

In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been
reported. These side effects occur generally within the first treatment week and are in most cases transient
and disappear following termination of the treatment but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or
subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and
NSAID are concomitantly administered, a risk for renal function cannot be excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Dogs:
Musculo-skeletal disorders:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body
weight). Metacam 1.5 mg/ml oral suspension for dogs or Metacam 1 mg and 2.5 mg chewable tablets for
dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight,
24 hours after administration of the injection.

Reduction of post-operative pain (over a period of 24 hours):
Single intravenous or subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e.
0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.

Cats:
Reduction of post-operative pain:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.

Particular care should be taken with regard to the accuracy of dosing.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 0.73 g/ml in dogs and 1.1 g/ml in cats were reached approximately 2.5 hours and
1.5 hours post administration, respectively.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range in dogs and cats. More than 97 % of meloxicam is bound to plasma proteins. The
volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism
In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an
acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive.

In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product
whereas urine contains only traces of the parent compound. Five major metabolites were detected all

having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid
derivative and to several polar metabolites. As for other species investigated, the main pathway of
meloxicam biotransformation in cat is oxidation.

Elimination
In dogs, meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered
dose is eliminated via faeces and the remainder via urine.

In cats, meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Sodium chloride
Glycine
Sodium hydroxide
Glycofurol
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/006 10 ml
EU/2/97/004/011 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 20 mg/ml solution for injection for cattle, pigs and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 20 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, pigs and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Pigs:
For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia
syndrome) with appropriate antibiotic therapy.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

See also section 4.7.
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam
alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated;
only a slight transient swelling at the injection site following subcutaneous administration was observed
in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals treated in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle and pigs: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares.
See also section 4.3.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.
2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Pigs:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body
weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of
meloxicam can be given after 24 hours.

Horses:
Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3.0 ml/100 kg body
weight).
For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a
dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, symptomatic treatment should be initiated.

4.11 Withdrawal period

Cattle: Meat and offal: 15 days; Milk: 5 days
Pigs: Meat and offal: 5 days
Horses: Meat and offal: 5 days.
Not authorised to use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves, lactating cows and pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 g/ml was reached after
1 hour in pigs.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain
only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. The
metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In pigs, after intramuscular administration the mean plasma elimination half-life is approximately
2.5 hours.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials):
3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20 ml, 50 ml or
100 ml.

Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/027 1 x 20 ml
EU/2/97/004/007 1 x 50 ml
EU/2/97/004/008 1 x 100 ml
EU/2/97/004/031 1 x 250 ml
EU/2/97/004/028 12 x 20 ml
EU/2/97/004/014 12 x 50 ml
EU/2/97/004/015 12 x 100 ml
EU/2/97/004/032 6 x 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 15 mg

Excipient:
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Horses

4.2 Indications for use, specifying the target species

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in
horses.

4.3 Contraindications

Do not use in pregnant or lactating mares.
Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage,
impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal
toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials
(slight urticaria, diarrhoea). Symptoms were reversible.
In very rare cases loss of appetite, lethargy, abdominal pain and colitis have been reported.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic
effects. However, no data have been generated in horses. Therefore the use in this species is not
recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body
weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small
quantity of food, prior to feeding.

The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 3 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli
endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption
When the product is used according to the recommended dosage regime the oral bioavailability is
approximately 98 %. Maximal plasma concentrations are obtained after approximately 23 hours. The
accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution
Approximately 98 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism
The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively
there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-
metabolites and the oxalyl-metabolite. The metabolism in horses was not investigated. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter
and a tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/009 100 ml
EU/2/97/004/030 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.02 mg per drop)

Excipients:
Sodium benzoate 1.5 mg (equivalent to 0.06 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs less than 6 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.
This product for dogs should not be used in cats due to the different dosing devices. In cats, Metacam
0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be
continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg
meloxicam/kg body weight.

For longer term treatment, once clinical response has been observed (after 4 days), the dose of Metacam
can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation
associated with chronic musculo-skeletal disorders may vary over time.

Particular care should be taken with regard to the accuracy of dosing.
Shake well before use.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using either the drop dispenser of the bottle (for very small breeds) or the
measuring syringe provided in the package.

Dosing procedure using the drop dispenser of the bottle:
Initial dose: 10 drops/kg body weight
Maintenance dose: 5 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to the maintenance dose. Thus for initiation of the therapy on the first day, twice the maintenance volume
will be required.
Alternatively therapy may be initiated with Metacam 5 mg/ml solution for injection.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days at
the latest if no clinical improvement is apparent.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated via faeces and the remainder via urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle containing 15 ml or 30 ml with a polyethylene dropper and a tamper-proof child-
resistant closure. Each bottle is packed in a cardboard box and is equipped with a polypropylene
measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/012 15 ml
EU/2/97/004/013 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 1 mg chewable tablets for dogs
Metacam 2.5 mg chewable tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Active substance:
Meloxicam 1 mg
Meloxicam 2.5 mg

Excipients:
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Chewable tablets.
Round mottled beige biconvex tablet, scored on the upper side with embedded code either "M10" or
"M25" on one side.
The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species. In cats,
Metacam 0.5 mg/ml oral suspension for cats should be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported. In very rare cases haemorrhagic diarrhoea,
haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

These side effects occur generally within the first treatment week and are in most cases transient and
disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be
given orally or alternatively using Metacam 5 mg/ml solution for injection for dogs and cats.

Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance
dose of 0.1 mg meloxicam/kg body weight.
Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily
maintenance dose for a 10 kg body weight dog, or a 25 kg body weight dog respectively.

Each chewable tablet can be halved for accurate dosing according to the individual body weight of the
dog. Metacam chewable tablets can be administered with or without food, are flavoured and are taken by
most dogs voluntarily.

Dose scheme for the maintenance dose:

Number of chewable tablets
Body weight (kg) mg/kg
1 mg 2.5 mg
4.07.0 0.130.1
7.110.0 1 0.140.1
10.115.0 1 0.150.1
15.120.0 2 0.130.1
20.125.0 1 0.120.1
25.135.0 1 0.150.1
35.150.0 2 0.140.1

The use of Metacam oral suspension for dogs may be considered for an even more precise dosing. For
dogs weighing less than 4 kg the use of Metacam oral suspension for dogs is recommended.

A clinical response is normally seen within 34 days. Treatment should be discontinued after 10 days if
no clinical improvement is apparent.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are
obtained after approximately 4.5 hours. When the product is used according to the recommended dosage
regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.3 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative
and to several polar metabolites. All major metabolites have been shown to be pharmacologically
inactive.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is
eliminated in faeces and the remainder in urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium citrate dihydrate
Starch, pregelatinized
Iron oxide brown
Iron oxide yellow
Cellulose, microcrystalline
Meat Dry Flavour
Silica, colloidal anhydrous
Magnesium stearate

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard boxes containing 7, 84 or 252 tablets in Alu/Alu child-resistant blisters.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

Metacam 1 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/043 7 tablets
EU/2/97/004/044 84 tablets
EU/2/97/004/045 252 tablets

Metacam 2.5 mg chewable tablets for dogs:
Blisters:
EU/2/97/004/046 7 tablets
EU/2/97/004/047 84 tablets
EU/2/97/004/048 252 tablets

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 0.5 mg (equivalent to 0.017 mg per drop)

Excipient:
Sodium benzoate 1.5 mg (equivalent to 0.05 mg per drop)

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Cats and guinea pigs

4.2 Indications for use, specifying the target species

Cats:
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Guinea pigs:
Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male
castration.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age.
Do not use in guinea pigs less than 4 weeks of age.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal
toxicity.

Post-operative use in cats and guinea pigs:
In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders in cats:
Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid
contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult
blood, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated
liver enzymes were reported in very rare cases.

These side effects are in most cases transient and disappear following termination of the treatment but in
very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(See section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic drugs should be avoided.

In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for
injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Cats:
Dosage
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours
later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg
meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:
Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is
to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg
meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be
discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration
Dosing procedure using the drop dispenser of the bottle:
Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight
Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.

Dosing procedure using the measuring syringe:
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds
to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculo-
skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the
treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be
required.

To be administered orally either mixed with food or directly into the mouth.
The suspension can be given using the drop dispenser of the bottle for cats of any body weight.
Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the
package can be used.
Particular care should be taken with regard to the accuracy of dosing.
The recommended dose should not be exceeded.

Guinea pigs:
Dosage
Post-operative pain associated with soft tissue surgery:
Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery).
Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg
meloxicam/kg body weight on day 2 to day 3 (post-surgery).

The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The
safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.

Route and method of administration
The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml
scale and 0.01 ml increments.

Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight
Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised
to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw
up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe
directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next
use.

Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs.

Advice on correct administration
Shake well before use.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at
relatively small overdose levels.
In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more
frequent. In case of overdose symptomatic treatment should be initiated.

In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of
0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of
doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Cats:
Absorption
If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately
3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown

to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

Guinea pigs:
No data available.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:
3 ml bottle: 2 years
10 ml, 15 ml and 30 ml bottle: 3 years.

Shelf life after first opening the immediate packaging:
3 ml bottle: 14 days
10 ml, 15 ml and 30 ml bottle: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper-proof child-resistant
closure.
Polyethylene bottle containing 10 ml, 15 ml or 30 ml with a polyethylene dropper and a tamper-proof
child-resistant closure.
Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe
which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/034 3 ml
EU/2/97/004/033 10 ml
EU/2/97/004/026 15 ml
EU/2/97/004/049 30 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 2 mg/ml solution for injection for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 2 mg

Excipients:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cats

4.2 Indications for use, specifying the target species

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in
cats, e.g. orthopaedic and soft tissue surgery.

4.3 Contraindications

Do not use in pregnant or lactating animals.
Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired
hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in cats less than 6 weeks of age nor in cats of less than 2 kg.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive cat, as there is a potential risk of renal
toxicity.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
In case additional pain relief is required, multimodal pain therapy should be considered.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

4.6 Adverse reactions (frequency and seriousness)

Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood,
lethargy and renal failure have occasionally been reported and in very rare cases gastrointestinal
ulceration and elevated liver enzymes.

These adverse reactions are in most cases transient and disappear following termination of the treatment
but in very rare cases may be serious or fatal.

In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation
(see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein
binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in
conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products should be avoided. In animals at anaesthetic risk (e.g. aged
animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration.
When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be
excluded.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and
accordingly a treatment-free period with such veterinary medicinal products should be observed for at
least 24 hours before commencement of treatment. The treatment-free period, however, should take into
account the pharmacological properties of the products used previously.

4.9 Amounts to be administered and administration route

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body
weight) before surgery, for example at the time of induction of anaesthesia.
To continue treatment for up to five days, this initial dose may be followed 24 hours later by
administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body
weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.

Single subcutaneous injection of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) has
also been shown to be safe and efficacious for the reduction of post-operative pain and inflammation.
This treatment can be considered in cats undergoing surgery where no oral follow-up treatment is possible

e.g. feral cats. In this case do not use oral follow up treatment.

Particular care should be taken with regard to the accuracy of dosing.
Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In the case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that
meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

5.2 Pharmacokinetic particulars

Absorption
Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma
concentrations of 1.1 g/ml were reached approximately 1.5 hours post administration.

Distribution
There is a linear relationship between the dose administered and plasma concentration observed in the
therapeutic dose range. More than 97 % of meloxicam is bound to plasma proteins. The volume of
distribution is 0.09 l/kg.

Metabolism
Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine
contains only traces of the parent compound. Five major metabolites were detected all having been shown
to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to
several polar metabolites. As for other species investigated, the main pathway of meloxicam
biotransformation in cat is oxidation.

Elimination
Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent
compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the
recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in
the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one colourless glass injection vial of 10 ml or 20 ml, closed with a rubber
stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/039 10 ml
EU/2/97/004/040 20 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998

Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 15 mg/ml oral suspension for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance(s):
Meloxicam 15 mg

Excipient(s):
Sodium benzoate 1.5 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension
Yellowish viscous oral suspension with a green tinge.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.
For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-
Agalactia syndrome MMA) with appropriate antibiotic therapy.

4.3 Contraindications

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders,
or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral
rehydration, as there may be a potential risk of renal toxicity.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid

contact with the veterinary medicinal product.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label
to the physician.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or
with anticoagulant agents.

4.9 Amounts to be administered and administration route

Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in
combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam
can be given after 24 hours.
In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam
20 mg/ml solution for injection is recommended.

To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to
feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits
onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the
measuring syringe with warm water and let it dry.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period

Meat and offal: 5 days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli

endotoxin administration in pigs.

5.2 Pharmacokinetic particulars

Absorption
After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 g/ml was reached after 2 hours.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. Bile and urine contain only traces of the parent compound.
Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major
metabolites have been shown to be pharmacologically inactive.

Elimination
After oral administration the mean plasma elimination half-life is approximately 2.3 hours.
Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate
Sorbitol, liquid
Glycerol
Saccharin sodium
Xylitol
Sodium dihydrogen phosphate dihydrate
Silica, colloidal anhydrous
Hydroxyethylcellulose
Citric acid
Honey aroma
Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging: 6 months.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter, a
tamper-proof child-resistant closure and a measuring syringe. Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

8. MARKETING AUTHORISATION NUMBERS

EU/2/97/004/041 100 ml
EU/2/97/004/042 250 ml

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metacam 40 mg/ml solution for injection for cattle and horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:
Meloxicam 40 mg

Excipient:
Ethanol 150 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection.
Clear yellow solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle and horses

4.2 Indications for use, specifying the target species

Cattle:
For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.
For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of
over one week of age and young, non-lactating cattle.
For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.
For the relief of post-operative pain following dehorning in calves.

Horses:
For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal
disorders.
For the relief of pain associated with equine colic.

4.3 Contraindications

Do not use in pregnant or lactating mares (see section 4.7).
Do not use in horses less than 6 weeks of age.
Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic
disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.

4.4 Special warnings for each target species

Treatment of calves with Metacam 20 minutes before dehorning reduces post-operative pain. Metacam

alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief
during surgery co-medication with an appropriate analgesic is needed.

4.5 Special precautions for use

Special precautions for use in animals
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be
sought.
Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral
rehydration, as there may be a potential risk of renal toxicity.
In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the
diagnosis should be made as this could indicate the need for surgical intervention.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental self-injection may give rise to pain. People with known hypersensitivity to non-steroidal anti-
inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the
label to the physician.

In view of the risk of accidental self-injection and the known adverse class-effects of NSAIDs and other
prostaglandin inhibitors on pregnancy and/or embryofoetal development, the veterinary medicinal product
should not be administered by pregnant women or women attempting to conceive.

4.6 Adverse reactions (frequency and seriousness)

In cattle, a slight transient painless swelling at the injection site was observed in most animals in
laboratory studies. This local reaction resolved within 8 hours following subcutaneous administration.

In horses, a transient swelling at the injection site can occur but resolves without intervention.

In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should
be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reactions)
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay

Cattle: Can be used during pregnancy and lactation.
Horses: Do not use in pregnant or lactating mares (see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.

4.9 Amounts to be administered and administration route

Cattle:
Single subcutaneous or intravenous injection at a dose of 0.5 mg meloxicam/kg body weight (i.e.
1.25 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as
appropriate.

Horses:
Single intravenous injection at a dose of 0.6 mg meloxicam/kg body weight (i.e. 1.5 ml/100 kg body
weight).

For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculo-
skeletal disorders, Metacam 15 mg/ml oral suspension may be used for continuation of treatment at a dose
of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal periods

Cattle: Meat and offal: 15 days; milk: 5 days.
Horses: Meat and offal: 5 days.
Not authorised for use in horses producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids (oxicams).
ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by
inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and
antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also
inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties
because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin
administration in calves and lactating cows.

5.2 Pharmacokinetic particulars

Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmaxvalues of 2.1 g/ml and 2.7 g/ml were
reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.

Distribution
More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to
be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in
milk and bile whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an
alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be
pharmacologically inactive. The metabolism in horses has not been investigated.

Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young
cattle and lactating cows, respectively.

In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.

Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Ethanol
Poloxamer 188
Macrogol 300
Glycine
Disodium edetate
Sodium hydroxide
Hydrochloric acid
Meglumine
Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other
veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Pack sizes of 1 or 12 colourless glass injection vial(s) each containing 50 ml or 100 ml.
Each vial is closed with a rubber stopper and sealed with an aluminium cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste
materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY

  1. MARKETING AUTHORISATION NUMBER(S)

EU/2/97/004/050053

  1. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07.01.1998
Date of last renewal: 06.12.2007

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European
Medicines Agency http://www.ema.europa.eu/.

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Cat » 30ml bottle

Metacam 0.5 mg/ml oral suspension for cats and guinea pigs

Presentation

Yellowish viscous oral suspension with a green tinge. One ml contains 0.5 mg meloxicam as active ingredient (equivalent to 0.017 mg per drop) and 1.5 mg sodium benzoate (equivalent to 0.05 mg per drop).

Uses

Cats

Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery. For alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.

Guinea pigs:

Alleviation of mild to moderate post-operative pain associated with soft tissue surgery such as male castration.

Dosage and administration

Cats:

Dosage

Post-operative pain and inflammation following surgical procedures:

After initial treatment with Metacam 2 mg/ml solution for injection for cats, continue treatment 24 hours later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

Acute musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.

Chronic musculo-skeletal disorders:

Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.05 mg meloxicam/kg body weight. A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

Route and method of administration

Dosing procedure using the drop dispenser of the bottle:

Dose of 0.2 mg meloxicam/kg body weight: 12 drops/kg body weight

Dose of 0.1 mg meloxicam/kg body weight: 6 drops/kg body weight

Dose of 0.05 mg meloxicam/kg body weight: 3 drops/kg body weight.

Dosing procedure using the measuring syringe:

The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to dose of 0.05 mg meloxicam/kg body weight. Thus for initiation of the treatment of chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be required. For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.

To be administered orally either mixed with food or directly into the mouth.

The suspension can be given using the drop dispenser of the bottle for cats of any body weight. Alternatively and for cats with a body weight of at least 2 kg, the measuring syringe provided in the package can be used.

Particular care should be taken with regard to the accuracy of dosing.

The recommended dose should not be exceeded.

Guinea pigs:

Dosage

Post-operative pain associated with soft tissue surgery:

Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on day 1 (pre-surgery). Treatment is to be continued once daily by oral administration (at 24-hours intervals) at a dose of 0.1 mg meloxicam/kg body weight on day 2 to day 3 (post-surgery).

The dose can, at the discretion of the veterinarian, be titrated up to 0.5 mg/kg in individual cases. The safety of doses exceeding 0.6 mg/kg has, however, not been evaluated in guinea pigs.

Route and method of administration

The suspension should be given directly into the mouth using a standard 1 ml syringe graduated with ml scale and 0.01 ml increments.

Dose of 0.2 mg meloxicam/kg body weight: 0.4 ml/kg body weight

Dose of 0.1 mg meloxicam/kg body weight: 0.2 ml/kg body weight

Use a small container (e.g. a teaspoon) and drop Metacam oral suspension into the container (it is advised to dispense a few drops more than required into the small container). Use a standard 1 ml syringe to draw up Metacam according to the bodyweight of the guinea pig. Administer Metacam with the syringe directly into the mouth of the guinea pig. Wash the small container with water and dry prior to the next use.

Do not use the cat syringe with the kg-body weight scale and the cat pictogram for guinea pigs.

Advice on correct administration

Shake well before use.

Avoid introduction of contamination during use.

Contra-indications, warnings, etc

Contraindications

Do not use in pregnant or lactating animals.

Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cats less than 6 weeks of age.

Do not use in guinea pigs less than 4 weeks of age.

Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

Post-operative use in cats and guinea pigs:

In case additional pain relief is required, multimodal pain therapy should be considered.

Chronic musculoskeletal disorders in cats:

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

In cats, typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases.

These side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reactions)

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Overdose (symptoms, emergency procedures, antidotes), if necessary

Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.

In case of overdose, adverse reactions, as listed in section 4.6, are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.

In guinea pigs, an overdose of 0.6 mg/kg body weight administred during 3 days followed by a dose of 0.3 mg/kg during 6 additional days did not cause adverse events typical for meloxicam. The safety of doses exceeding 0.6 mg/kg has not been evaluated in guinea pigs.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (See section 4.3).

Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulant, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Metacam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided.

In cats, pre-treatment with anti-inflammatory substances other than Metacam 2 mg/ml solution for injection for cats at a single dose of 0.2 mg/kg may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Pharmaceutical precautions

Shelf life of the veterinary medicinal product as packaged for sale:

3 ml bottle: 2 years

10 ml, 15 ml and 30 ml bottle: 3 years.

Shelf life after first opening the immediate packaging:

3 ml bottle: 14 days

10 ml, 15 ml and 30 ml bottle: 6 months.

This veterinary medicinal product does not require any special storage conditions.

Keep out of the sight and reach of children. For animal treatment only.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Packaging quantities

Polypropylene bottle containing 3 ml with a polyethylene dropper and a tamper-proof child-resistant closure.

Polyethylene bottle containing 10 ml, 15 ml or 30 ml with a polyethylene dropper and a tamper-proof child-resistant closure.

Each bottle is packed in a cardboard box and is equipped with a 1 ml polypropylene measuring syringe which has a kg-body weight scale for cats (2 to 10 kg) and a pictogram showing a cat.

Further information

Pharmacodynamic properties

Meloxicam is a Non-Steroidal Anti-Inflammatory Drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic properties

Cats:

Absorption

If the animal is fasted when dosed, the maximal plasma concentrations are obtained after approximately 3 hours. If the animal is fed at the time of dosing, the absorption may be slightly delayed.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97 % of meloxicam is bound to plasma proteins.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cat is oxidation.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21% of the recovered dose is eliminated in urine (2% as unchanged meloxicam, 19% as metabolites) and 79% in the faeces (49% as unchanged meloxicam, 30% as metabolites).

Guinea pigs:

No data available.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing Authorisation Number

EU/2/97/004/034 – 3 ml

EU/2/97/004/033 – 10 ml

EU/2/97/004/026 – 15 ml

EU/2/97/004/049 – 30 ml

Pig » 100ml Bottle

Metacam 15 mg/ml oral suspension for pigs

Presentation

Yellowish viscous oral suspension with a green tinge. One ml contains meloxicam 15 mg as active substance and Sodium benzoate 1.5 mg.

Uses

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (Mastitis-Metritis-Agalactia syndrome MMA) with appropriate antibiotic therapy.

Dosage and administration

Oral suspension to be administered at a dosage of 0.4 mg/kg body weight (i.e. 2.7 ml/100 kg) in combination with antibiotic therapy, as appropriate. If required, a second administration of Meloxicam can be given after 24 hours. In cases of MMA with severely disturbed general demeanour (e.g. anorexia) the use of Metacam 20 mg/ml solution for injection is recommended.

To be administered preferably mixed with a small quantity of feed. Alternatively to be given prior to feeding, or directly into the mouth.

The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.

Shake well before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

Contra-indications, warnings, etc

Do not use in pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Special precautions for use in animals

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in very severely dehydrated, hypovolaemic or hypotensive pigs which require parenteral rehydration, as there may be a potential risk of renal toxicity.

Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

Can be used during pregnancy and lactation.

In case of overdose symptomatic treatment should be initiated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Withdrawal period

Meat and offal: 5 days.

Pharmaceutical precautions

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening of the immediate packaging: 6 months.

Keep out of sight and reach of children. For animal treatment only.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Legal category

Packaging quantities

Cardboard box containing one polyethylene bottle of 100 ml or 250 ml with a polyethylene tip adapter, a tamper proof child resistant closure and a measuring syringe. Not all pack sizes may be marketed.

Further information

Pharmacodynamic properties

Meloxicam is a Non-Steroidal Anti-Inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in pigs.

Pharmacokinetic particulars

Absorption

After a single oral dose of 0.4 mg meloxicam/kg a Cmax value of 0.81 µg/ml was reached after 2 hours.

Distribution

More than 98 % of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.

Metabolism

Meloxicam is predominantly found in plasma. Bile and urine contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

After oral administration the mean plasma elimination half-life is approximately 2.3 hours. Approximately 50 % of the administered dose is eliminated via urine and the remainder via faeces.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim/Rhein, Germany

Marketing Authorisation Number

EU/2/97/004/041 100 ml

EU/2/97/004/042 250 ml

Delivery Information

How quickly do you deliver?

Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

What do you charge for delivery?

For UK delivery, we charge the following:

Order Total Weight Delivery
£0-£28.99 Under 2kg £2.99
2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

Due to restrictions aerosols can't be sent by Royal Mail. We appreciate your understanding.

Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

Reviews (254)

Q & A

Below are some recent questions we've received regarding Metacam Oral Suspension, including answers from our team.

14 September 2016 at 6:49pm

Oral Metacam

Derek Thomson

  • VioVet customer since 2012
  • From: Highland, United Kingdom

Once opened how long will a bottle last, as Charlie does not need it all the time at present?

  • Veterinary Advisor

The manufacturers suggest that once opened the bottle will last 6 months and that you should discard the bottle even if you have some left after this time.

24 March 2016 at 4:09pm

Metacam and liver shunt

Sharon short

Can I give my 3 year old dog who has liver shunt metacam?

  • Non-Executive Director

This is a very good question. The situation is that Metacam is remarkably safe in most dogs, but much less so if they suffer from certain medical conditions. Reduced liver function is one of these, so there is certainly a risk involved in using Metacam in your dog. That does not mean it is definitely a bad idea, but you have to balance that risk against the perceived benefit (control of pain and inflammation). You should discuss it with your vet who will be more familiar with the precise nature and degree of your dog's condition. I must admit that it I were going to use Metacam, I would start at a very lose dose and possibly monitor liver enzyme levels etc while doing so. If you feel your dog does not particularly need this treatment, it would be safer to avoid it.

12 July 2015 at 12:28am

Is my vet obliged to write a prescription?

Marina

My retired greyhound has an occasional limp . Leg support helps to a degree but Metacam even more so. It is very expensive getting it from the vet so was going to ask for a prescription. Can vet refuse to write one? Thanks.

  • Brand Manager

If your vet is prepared to supply you with a particular medication such as Metacam, then they are not allowed to refuse to write you a prescription. They are howver allowed to charge a small feed which is usually about £10-15. For long term medication, you can ask your vet to write repeats which will allow you to use the prescription multiple times before going back for a new one which will save more money.

A vet may only refuse to write a prescription if they are not willing to prescribe and supply you with the medication themselves, as this means that they do not feel it is suitable for your animal.

You can then email, fax, upload or post your prescription to us.

16 December 2013 at 2:24pm

Can Metacam cause a blocked bladder?

Donald Field

Our customer asked if the Metacam given to her lame cat could have caused the blocked bladder which happened 36 hours later.

  • Non-Executive Director

There will not be a direct link with the Metacam, but possibly an indirect one:

Any male cat prone to any cystitis type problem is at risk of developing urethral obstruction at some point in future. It is not rare. Various factors increase that risk, including illness of some other type, altered eating and drinking habits, reduced mobility for a while (and holding on to the urine for longer than normal) etc. These other things might have triggered the cystitis, but it could have happened just the same, with or without the Metacam.

Personally I would suggest that in future you do not give your cat any dried food. If he eats only moist food, he is very unlikely ever to get these urinary problems, because they are rare in cats producing dilute urine. Cats on dried food can produce very concentrated urine at times, which is a risk factor in itself.

26 July 2013 at 12:52pm

Cat/dog

liz b

Can I use the metacam I have for dogs for my arthritic cat? Presumably with reduced dosage?

  • Non-Executive Director

Metacam for dogs came out long before the cat version. Until that time, Metacam for dogs was commonly used in cats. This can however cause serious trouble if it is done inappropriately and if the cat has kidney or gastro-intestinal trouble, or is ill in some other way. Therefore we would not be able to recommend you do this without talking to your own vet first. Doing as you suggest is in fact against current prescribing regulations, so your vet might not feel able to help much either. (Metacam for dogs is three times as strong as the cat version, and the dose rate for dogs is twice that for cats anyway, so a cat should receive one sixth of the amount recommended for a dog of the same weight.)