Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Enrofloxacin

Disponible depuis:

Chanelle Pharmaceuticals Manufacturing Limited

Code ATC:

QJ01MA90

DCI (Dénomination commune internationale):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Bovine, Porcine

Domaine thérapeutique:

enrofloxacin

indications thérapeutiques:

Antibacterial

Statut de autorisation:

Authorised

Date de l'autorisation:

2010-07-16

Résumé des caractéristiques du produit

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.
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