Pays: Royaume-Uni
Langue: anglais
Source: VMD (Veterinary Medicines Directorate)
Mavacoxib
Zoetis UK Limited
QM01AH92
Mavacoxib
Chewable tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Anti Inflammatory NSAID
Authorized
2008-09-09
Issued: October 2023 AN: 01444/2022 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Trocoxil 20 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCE: Mavacoxib 20 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablets Triangular tablet with mottled brown appearance embossed with the tablet strength on one side, the reverse side is blank. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs aged 12 months or more. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated. 4.3 CONTRAINDICATIONS Do not use in dogs less than 12 months of age and/or less than 5 kg body weight. Do not use in dogs suffering from gastro-intestinal disorders including ulceration and bleeding. Do not use where there is evidence of a haemorrhagic disorder. Do not use in cases of impaired renal or hepatic function. Do not use in cases of cardiac insufficiency. Issued: October 2023 AN: 01444/2022 Page 2 of 8 Do not use in pregnant, breeding or lactating dogs. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in case of known hypersensitivity to sulphonamides. Do not use concomitantly with glucocorticoids or other Non-Steroidal Anti- Inflammatory Drugs (NSAIDs), see section 4.8. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not administer other NSAIDs or glucocorticoids concurrently or within 1 month of the last administration of Trocoxil. 4.5 SPECIAL PRECAUTIONS FOR USE i. 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 Lire le document complet