Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: VMD (Veterinary Medicines Directorate)
Nimesulide
Virbac S.A.
QM01AX17
Nimesulide
Expired
1. NAME OF THE VETERINARY MEDICINAL PRODUCT SULIDENE 100 MG TABLET FOR DOGS (ZOLAN 100 MG TABLET FOR DOGS, UK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 tablet contains: ACTIVE SUBSTANCE Nimesulide 100 mg EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Round light yellow divisible tablet 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES Reduction of inflammation and relief of pain associated with musculo-skeletal disorders. 4.3 CONTRAINDICATIONS Do not use in animals suffering from gastrointestinal ulceration or bleeding. Do not use where there is hypersensitivity to the product. Do not use in animals suffering from cardiac, hepatic or renal impairment. Do not use where there is evidence of a blood dyscrasia. Do not use in puppies younger than 4 months. Do not use in cats. And see section 4.7. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A dark yellow discoloration of the serum and urine may be observed in treated animals. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS - The dog should be monitored for signs of gastrointestinal disturbances. - Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of increased renal toxicity. - If side effects occur, treatment should be discontinued and the advice of a veterinary surgeon should be sought. 1 - Concurrent use of potentially nephrotoxic drugs should be avoided. - As with other NSAIDs, use in aged animals may involve additional risk. - Do not exceed the stated dose or the duration of treatment. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINAY MEDICINAL PRODUCT TO ANIMALS: In case of accidental ingestion by a child, seek medical advice immediately and show the package insert or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Typical undesirable effects associated with NSAIDs are vomiting, soft faeces/diarrhoea, blood in faeces, reduced appetite and letha Διαβάστε το πλήρες έγγραφο