FLOXIBAC 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ENROFLOXACIN

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

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:

2010-07-16

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Floxibac 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
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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