Metacam Oral Suspension

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

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

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

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

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

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

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

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

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