Dogs

For the treatment of pain and inflammation associated with osteoarthritis (or degenerative joint disease) in dogs.

Do not use in animals suffering from gastrointestinal disorders, protein or blood losing enteropathy or haemorrhagic disorders. Do not use in cases of impaired renal or hepatic function. Do not use in cases of cardiac insufficiency. Do not use in pregnant or lactating dogs. Do not use in animals intended for breeding purposes. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.Do not use in cases of known hypersensitivity to sulphonamides. Do not use in any dehydrated, hypovolemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

Do not administer other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or glucocorticoids concurrently or within 2 weeks of the last administration of this veterinary medicinal product.

Since the safety of the medicinal product has not been fully demonstrated in very young animals, careful monitoring is advised during the treatment of young dogs aged less than 6 months. The active metabolite of enflicoxib exhibits an extended plasma half-life due to its low rate of elimination. Use this veterinary medicinal product under strict veterinary monitoring where there is a risk of gastrointestinal ulceration, or if the animal previously displayed intolerance to NSAIDs.

This veterinary medicinal product can cause hypersensitivity (allergic) reactions. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product. Some NSAIDs may be harmful for the unborn child, especially during the third trimester of pregnancy. Pregnant women should administer this veterinary medicinal product with care. Ingestion of this veterinary medicinal product may be harmful, especially for children, and prolonged pharmacological effects leading to e.g. gastrointestinal disorders may be observed. To avoid accidental ingestion, administer the tablet to the dog immediately after removal from the blister packaging and do not split or crush tablets. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Vomiting, soft faeces and/or diarrhoea have been commonly reported in clinical trials, but most cases recovered without treatment. Apathy, loss of appetite or haemorrhagic diarrhoea have been reported in uncommon cases. Gastrointestinal ulceration has been reported in uncommon cases. Elevated blood urea and serum cholesterol levels were observed in healthy, young dogs at the recommended dose in a laboratory safety study. In case of adverse reactions the use of the veterinary medicinal product should be stopped and general supportive therapy, as for clinical overdose with NSAIDs, should be applied until complete resolution of the signs. Particular attention should be paid to maintain haemodynamic status. Gastrointestinal protectants and parenteral fluids, as appropriate, may be required for animals that experience gastrointestinal or renal adverse reactions.

Laboratory studies in rats and rabbits have shown evidence of foetotoxic effects at maternally toxic doses. The safety of this veterinary medicinal product has not been established during pregnancy, lactation or reproduction in the target species. Do not use in pregnant, lactating or breeding dogs.

No drug-interaction studies have been performed. In common with other NSAIDs, this veterinary medicinal product should not be administered simultaneously with other NSAIDs or glucocorticoids. Animals should be carefully monitored if this veterinary medicinal product is administered simultaneously with an anticoagulant. Enflicoxib is highly bound to plasma proteins and may compete with other highly bound substances, such that concomitant administration may result in toxic effects. Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse reactions. To avoid such adverse reactions when this veterinary medicinal product is to be administered in replacement to another NSAID, ensure an appropriate treatment-free period before administering the first dose. The treatmentfree period should, however, consider the pharmacology of the medicinal products previously used. Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided.

Oral use.

Dosing interval is ONCE PER WEEK.

First dose: 8 mg enflicoxib per kg body weight.

Maintenance dose: repeat the treatment every 7 days at the dose of 4 mg enflicoxib per kg body weight.

The veterinary medicinal product should be given immediately before or with the dog’s meal. The bodyweight of animals to be treated should be accurately determined to ensure administration of the correct dose.

In overdose safety studies at a continuous weekly administration at 12 mg/kg body weight for a period of 7 months and at 20 mg/kg body weight for a period of 3 months, with an initial loading dose, there was evidence of elevated blood urea and serum cholesterol levels. No other associated treatment related effects were detected.

Not applicable.