Pale yellow granules in sachet.

One sachet contains:

Active substance: meloxicam 330 mg.

Horses.

Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses weighing between 500 and 600 kg.

In-feed use.

To be administered mixed with food at a dose of 0.6 mg/kg body weight, once daily, up to 14 days. The product should be added to 250 g of muesli feed, prior to feeding.

Each sachet contains one dose for a horse weighing between 500 and 600 kg and the dose must not be divided into smaller doses.

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 case of hypersensitivity to the active substance or to any of the excipients.

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

None.

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

In order to minimise risk of intolerance, the product should be mixed into muesli feed.

This product is only for use in horses weighing between 500 and 600 kg.

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.

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.

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 horses is not recommended during pregnancy and lactation.

Do not administer concurrently with glucocorticoids, other NSAIDs or with anti-coagulant agents.

In the case of overdose symptomatic treatment should be initiated.

Meat and offal: 3 days.

Not authorised for use in lactating animals producing milk for human consumption

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.

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.

Approximately 98% of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

The metabolism is qualitatively similar in rats, humans, cattle and pigs (including mini-pigs), although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxyand 5-carboxy- metabolites and the oxalyl- metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.

Meloxicam is eliminated with a terminal half-life of 7.7 hours.

Glucose monohydrate

Povidone

Apple flavour (containing butylated hydroxyanisole (E320))

Crospovidone

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

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after incorporation into muesli feed: use immediately.

This veterinary medicinal product does not require any special storage conditions

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

Paper foil sachets (paper/PE/alu/PE) containing 1.5 g granules per sachet in a cardboard box.

Pack size: 20 and 100 sachets.

Not all pack sizes may be marketed.

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea,

Co. Galway,

IRELAND

VM 08749/5016