FENOFLOX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Preparatomtale
(SPC)
15-09-2015
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Aktiv ingrediens:
ENROFLOXACIN
Tilgjengelig fra:
Chanelle Pharmaceuticals Manufacturing Limited
ATC-kode:
QJ01MA90
INN (International Name):
ENROFLOXACIN
Dosering :
100 Mg/Ml
Legemiddelform:
Solution for Injection
Resept typen:
POM
Terapeutisk gruppe:
Bovine, Porcine
Terapeutisk område:
Enrofloxacin
Indikasjoner:
Antibacterial
Autorisasjon status:
Authorised
Autorisasjon dato:
2010-05-14
Preparatomtale
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear light yellow solution free from particulate matter.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of bacterial infections caused by strains susceptible to enrofloxacin.
Cattle
Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of _Pasteurella multocida,_
_Mannheimia haemolytica _and _Mycoplasma _spp.
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 the alimentary tract caused by enrofloxacin susceptible strains of _Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains of _Escherichia coli_.
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENT:
n-butanol
30 mg
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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