Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
aniMedica GmbH
QJ01MA90
ENROFLOXACIN
5 Mg/Ml
Oral Solution
POM
Porcine
Enrofloxacin
Antibacterial
Authorised
2013-06-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 5 mg/ml oral solution for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral solution. Clear slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (piglets) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections of the respiratory and alimentary tract caused by enrofloxacin-sensitive microorganisms. In particular: • Treatment of neonatal diarrhoea and septicaemia caused by enrofloxacin-sensitive_ E. coli_ • Treatment of respiratory infections caused by enrofloxacin-sensitive_ Pasteurella multocida_,_ Mannheimia_ _haemolytica_ and_ Mycoplasma spp._ • Enzootic pneumonia To be used where clinical experience and/or sensitivity testing indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance, or to any of the 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. 1 ml contains: ACTIVE SUBSTANCE: Enrofloxacin 5.0 mg EXCIPIENTS: Benzyl alcohol (E-1519) 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_ _ _ _1_ _3_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _6_ _2_ _5_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _ Olvassa el a teljes dokumentumot