One ml contains:

Active substance: meloxicam 15 mg. Excipient: sodium benzoate 1.5 mg

Yellowish viscous oral suspension with a green tinge.

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

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.

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.

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

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.

This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.

Diarrhoea, typically associated with NSAIDs, was very rarely observed in clinical trials. The clinical sign was reversible.

Loss of appetite, lethargy, abdominal pain, colitis and urticaria have been reported very rarely from post-marketing safety experience.

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

Meat and offal: 3 days.

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.

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.

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.

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.

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein

Germany

UK(GB): Vm 04491/5018