Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Bayer Limited
QJ01MA90
ENROFLOXACIN
5.0 Mg/Ml
Oral Solution
POM
Porcine
Enrofloxacin
Antibacterial
Authorised
1988-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Piglet Doser 0.5% Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral Solution. Clear aqueous solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Piglets. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is for use in the treatment of diseases of the respiratory and alimentary tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia and salmonellosis), and multifactorial diseases such as atrophic rhinitis and enzootic pneumonia, where clinical experience, supported where possible by sensitivity testing of the casual organism, indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS Should not be used for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. Active Constituents mg per ml Enrofloxacin 5.0 Relevant Constituents of the Excipient Benzyl Alcohol 14.0 For full list of excipients see section 6.1 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_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _6_ _6_ _2_ _4_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are exp Read the complete document