Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Vetpharma Animal Health, S.L.
QJ01MA90
Enrofloxacin
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
enrofloxacin
Antibacterial
Authorised
2011-05-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Unisol 100 mg/ml solution for injection for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Enrofloxacin 100.0 mg EXCIPIENTS Benzyl alcohol (E1519) 7.8 mg Disodium edetate 10.0 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear slightly yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs 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_ _3_ _/_ _1_ _2_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _2_ _1_ _7_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of_ Pasteurella multocida,_ _Mannheimia haemolytica_ and_ Mycoplasma_ spp. Treatment of acute severe mastitis caused by enrofloxacin susceptible strains of_ Escherichia coli_. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of_ Escherichia coli_. Treatment of septicaemia caused by enrofloxacin susceptible strains of_ Escherichia coli_. Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of_ Mycoplasma bovis_ in cattle less than 2 years old. PIGS Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of_ Pasteurella multocida_, _Mycoplasma_ spp. a Lestu allt skjalið