Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Krka, d.d., Novo mesto
QJ01MA93
Marbofloxacin
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
marbofloxacin
Antibacterial
Authorised
2011-08-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marfloxin 100 mg/ml solution for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Marbofloxacin 100 mg EXCIPIENTS: Disodium edetate 0.10 mg Monothioglycerol 1 mg Metacresol 2 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear, greenish yellow to brownish yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: - treatment of respiratory infections caused by sensitive strains of_ Pasteurella multocida, Mannheimia haemolytica_ and _Histophilus somni._ - treatment of acute_ E.coli_ mastitis_._ In pigs: - treatment of Metritis Mastitis Agalactia (MMA) syndrome caused by susceptible strains of organisms. 4.3 CONTRAINDICATIONS Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance). Do not administer in animals with known hypersensitivity to fluoroquinolones, or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 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_ _1_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _2_ _0_ _4_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Official and local antimicrobial policies should be taken into account wh Leggi il documento completo