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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 £3.79
  • Dog » 32ml Bottle £8.50
  • Dog » 100ml Bottle £20.50
  • Dog » 180ml Bottle £25.00
  • Horse » 100ml Bottle £40.49
  • Horse » 250ml Bottle £77.99
  • Pig » 100ml Bottle £50.50

Selection of 10 products from

£3.79 to £77.99

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

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 » 100ml Bottle

Metacam 15 mg/ml oral suspension for horses

Presentation

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

Uses

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

Dosage and administration

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.

Contra-indications, warnings, etc

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.

Special precautions for use in animals

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

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).

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.

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

In the case of overdose symptomatic treatment should be initiated.

Withdrawal period

Meat and offal: 3 days.

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 of 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

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.

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 calves and pigs.

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 2 - 3 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.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing Authorisation Number

EU/2/97/004/009 : 100 ml

EU/2/97/004/030 : 250 ml

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

Metacam 15 mg/ml oral suspension for horses

Presentation

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

Uses

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

Dosage and administration

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.

Contra-indications, warnings, etc

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.

Special precautions for use in animals

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

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).

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.

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

In the case of overdose symptomatic treatment should be initiated.

Withdrawal period

Meat and offal: 3 days.

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 of 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

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.

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 calves and pigs.

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 2 - 3 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.

Marketing Authorisation Holder (if different from distributor)

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

Marketing Authorisation Number

EU/2/97/004/009 : 100 ml

EU/2/97/004/030 : 250 ml

Cat » 3ml 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

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 (247)

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.)