Clear yellow solution for injection. One ml contains 40 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.

Horses:

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

For the relief of pain associated with equine colic.

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

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

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

Avoid introduction of contamination during use.

Do not use in pregnant or lactating mares.

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

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

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

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

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: Can be used during pregnancy and lactation.

Horses: Do not use in pregnant or lactating mares.

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

In case of overdose, symptomatic treatment should be initiated.

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

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 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).

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.

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

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.

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

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

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

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

To be supplied only on veterinary prescription.

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

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

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

Absorption: 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.

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

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

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein

GERMANY

UK(GB): Vm 04491/5023