ENROXIL 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-04-2015
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Active ingredient:
ENROFLOXACIN
Available from:
Krka, d.d., Novo mesto
ATC code:
QJ01MA90
INN (International Name):
ENROFLOXACIN
Dosage:
100 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Enrofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2009-07-10
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enroxil 100 mg/ml solution for injection for cattle and pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution practically free from particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs.
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 the alimentary tract caused by enrofloxacin susceptible strains of _Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains of _Escherichia coli_.
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENT(S):
n-butyl alcohol as antimicrobial preservative 30 mg
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