País: Grècia
Idioma: anglès
Font: HMA (Heads of Medicines Agencies)
nimesulide 100 mg
Virbac S.A.
QM01AX17
Tablet
nimesulide
Dogs
2010-01-19
1 _[Version 7.1, 10/2006] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS SULIDENE 100 mg RENEWAL Final SPC March 2007 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT SULIDENE 100 MG TABLET FOR DOGS 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. SULIDENE 100 mg RENEWAL Final SPC March 2007 3 - If side effects occur, treatment should be discontinued and the advice of a vete Llegiu el document complet