Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Vetpharma Animal Health, S.L.
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
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 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 23/12/2016_ _CRN 7025217_ _page number: 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. and _Actinobacillus pleuropneumoniae_. Treatment of infections of the urinary tract caused by enrofloxacin susceptible strains of _Escherichia coli._ Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of _Escherichia coli _and _Klebsiella _spp. Treatment of infections of t Прочитать полный документ