Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Enrofloxacin
SP Veterinaria, S.A.
QJ01MA90
Enrofloxacin
25 milligram(s)/millilitre
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
enrofloxacin
Antibacterial
Authorised
2010-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT COLMYC 25 mg/ml ORAL SOLUTION for calves 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral solution. Clear yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In calves: - treatment of respiratory infections due to_ Pasteurella multocida_ and_ Mannheimia haemolytica_ - treatment of gastro-intestinal infection due to_ Escherichia coli_. To be used where clinical experience and/or sensitivity testing indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS Do not use in cases of confirmed, or suspected, resistance to quinolones. Do not use in cases of known hypersensitivity to the active substance, to other (fluoro)quinolones or to any of excipients. Do not use in case of disturbances in growth of cartilage and/or during injury of locomotory system particularly on functionally loaded joints or due to body weight loaded joints. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin 25.0 mg EXCIPIENTS: Benzyl alcohol (E1519) 14.0 mg For the 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_ _ _ _0_ _4_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _6_ _6_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Do not use for prophylaxis. Of Perskaitykite visą dokumentą