Clear yellow solution for injection. One ml contains 20 mg meloxicam (active substance) and 150 mg ethanol (excipient).

Cattle:

For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

For use in diarrhoea, in combination with oral re-hydration therapy, to reduce clinical signs in calves of over one week of age and young non-lactating cattle.

For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.

For the relief of post-operative pain following dehorning in calves.

For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation.

For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.

For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.

For the relief of pain associated with equine colic.

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

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

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

Avoid introduction of contamination during use.

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

Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

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

For the treatment of diarrhoea, do not use in animals less than one week of age.

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

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

Horses: Do not use in pregnant or lactating mares.

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

In case of overdose, symptomatic treatment should be initiated.

In cattle only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.

In horses, a transient swelling at the injection site was observed in isolated cases in clinical studies, but resolved without intervention.

Anaphylactoid reactions, which may be serious (including fatal), have been observed very rarely from post-marketing safety experience and should be treated symptomatically.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment)

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

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

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

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

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

Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.

Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Meat and offal – 15 days.

Milk – 5 days.

Meat and offal – 5 days.

Meat and offal - 5 days.

Not authorised to use in horses producing milk for human consumption.

Shelf-life of the veterinary medicinal product as packaged for sale (20 ml, 50 ml, 100 ml or 250 ml vials): 3 years.

Shelf-life after first opening the immediate packaging: 28 days.

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.

Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 20 ml, 50 ml or 100 ml. Cardboard box with either 1 or 6 colourless glass injection vial(s) each containing 250 ml. Each vial is closed with a rubber stopper and sealed with an aluminium cap. Not all pack sizes may be marketed.

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

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

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.

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

Meloxicam is eliminated with a half life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively. In pigs, after intramuscular injection, the mean plasma elimination half life is approximately 2.5 hours. In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours. Approximately 50% of the administered dose is eliminated via urine and the remainder via faeces.

Boehringer Ingelheim Vetmedica GmbH,

55216 Ingelheim/Rhein,

GERMANY

UK(GB): Vm 04491/5021