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

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ixtrih issa

DSU DSU (DSU)
08-11-2023

Ingredjent attiv:

Enrofloxacin

Disponibbli minn:

Chanelle Pharmaceuticals Manufacturing Limited

Kodiċi ATC:

QJ01MA90

INN (Isem Internazzjonali):

Enrofloxacin

Dożaġġ:

100 milligram(s)/millilitre

Għamla farmaċewtika:

Solution for injection

Tip ta 'preskrizzjoni:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupp terapewtiku:

Bovine, Porcine

Żona terapewtika:

enrofloxacin

Indikazzjonijiet terapewtiċi:

Antibacterial

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2010-07-16

Karatteristiċi tal-prodott

                                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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