TROCOXSIL

Special precautions for use in animals
Mavacoxib exhibits an extended plasma half life (up to > 80 days, see section 5.2) due to its low rate of elimination. This corresponds to a duration of effect of 1-2 months after administration of the second dose (and following doses). Care should be taken to avoid treatment of animals that might not tolerate prolonged NSAID exposure. A maximum treatment administration of 6.5 months continuous therapy is recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination
Animals should undergo a thorough clinical examination before commencing treatment with Trocoxil and appropriate laboratory tests to monitor haematology and clinical chemistry are recommended. Animals with evidence of impaired renal or hepatic function, or with evidence of a protein or blood losing enteropathy are not suitable for treatment with Trocoxil. It is recommended to repeat the clinical examination one month after commencing treatment with Trocoxil and prior to administration of the third dose with additional monitoring of clinical pathology as appropriate during treatment.
Mavacoxib is excreted via bile and in dogs with hepatic disorders reduced elimination and thus excessive accumulation could occur. For this reason dogs with hepatic disorders should not be treated.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic medicinal products should be avoided.
Ensure appropriate hydration and haemodynamic status when animals receiving Trocoxil undergo anaesthesia and/or surgical procedures or develop conditions which may result in dehydration or compromised haemodynamic status. The key aim of intervention is to maintain renal perfusion. Patients with underlying renal disease may experience exacerbation or decompensation of their renal disease while on NSAID therapy. (See also section 4.6).
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self-ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Ingestion of Trocoxil may be harmful 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.
People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.
Do not eat, drink, or smoke when handling the product. Wash hands after handling the product.

4.6 Adverse reactions (frequency and seriousness)
Adverse reactions of the digestive tract such as vomiting and diarrhoea were commonly reported, loss of appetite, haemorrhagic diarrhoea and melaena have been reported in uncommon cases. Gastrointestinal ulceration was reported in rare cases. Apathy, degradation of renal biochemistry parameters and impaired renal function have been reported in uncommon cases. In rare cases these adverse reactions may be fatal.
If an adverse reaction following the administration of Trocoxil occurs, no further tablets should be administered and general supportive therapy, as applied to clinical overdose with NSAIDs, should be applied. Particular attention should be paid to maintaining haemodynamic status.
Gastrointestinal protectants and parenteral fluids, as appropriate, may be required for animals that experienced gastrointestinal or renal adverse reactions. Veterinarians should be aware that clinical signs of adverse reactions may continue when supportive therapy (such as gastro protectants) is discontinued.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)