Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Bayer Limited
QJ01MA90
Enrofloxacin
15 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Dogs
enrofloxacin
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Flavour Tablets 15 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet. A light brown to brown, slightly marbled, round, planar tablet for oral administration to dogs and cats. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is for use in dogs and cats in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of the choice. 4.3 CONTRAINDICATIONS Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth. Not recommended for use in cats less than 8 weeks of age. Baytril Flavour Tablets 15 mg should not be used for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Please refer to item 4.3. Cats: Retinotoxic effects including blindness can occur when the recommended dose is exceeded. Active Constituents mg/tablet Enrofloxacin 15 Relevant constituents of the Excipient Artificial beef flavour Irradiated. 6.0 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _8_ _/_ _0_ _4_ _/_ _2_ _0_ _ Læs hele dokumentet