البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
mavacoxib
Zoetis Belgium SA
QM01AH92
mavacoxib
Dogs
Anti inflammatory and antirheumatic products
For the treatment of pain and inflammation associated with degenerative joint disease in dogs in cases where continuous treatment exceeding one month is indicated.
Revision: 10
Authorised
2008-09-09
15 B. PACKAGE LEAFLET 16 PACKAGE LEAFLET: TROCOXIL 6 MG CHEWABLE TABLETS FOR DOGS TROCOXIL 20 MG CHEWABLE TABLETS FOR DOGS TROCOXIL 30 MG CHEWABLE TABLETS FOR DOGS TROCOXIL 75 MG CHEWABLE TABLETS FOR DOGS TROCOXIL 95 MG CHEWABLE TABLETS FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Pfizer Italia s.r.l. Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) ACTIVE SUBSTANCE: Mavacoxib 6 mg Mavacoxib 20 mg Mavacoxib 30 mg Mavacoxib 75 mg Mavacoxib 95 mg Tablets also contain the following ingredients: Sucrose Silicified microcrystalline cellulose Artificial powdered beef flavour Croscarmellose sodium Sodium laurylsulfate Magnesium stearate Triangular tablet with mottled brown appearance embossed with the tablet strength on one side, the reverse side is blank. 17 4. INDICATION(S) Trocoxil chewable tablets are indicated for the treatment of pain and inflammation associated with degenerative joint disease in dogs where treatment for more than one month is needed. Trocoxil belongs to a group of medicines called Non-steroidal Anti-inflammatory drugs (NSAIDs) which are used to treat pain and inflammation. 5. 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 kidney or liver function. Do not use in cases of heart insufficiency. اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Trocoxil 6 mg chewable tablets for dogs Trocoxil 20 mg chewable tablets for dogs Trocoxil 30 mg chewable tablets for dogs Trocoxil 75 mg chewable tablets for dogs Trocoxil 95 mg chewable tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains: ACTIVE SUBSTANCE: Mavacoxib 6 mg Mavacoxib 20 mg Mavacoxib 30 mg Mavacoxib 75 mg Mavacoxib 95 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 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. 3 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 Special precautions for use in animals Mavacoxib exhibits an ex اقرأ الوثيقة كاملة