DORAFLOX 100 mg/ml solution for injection for cattle and pigs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Enrofloxacin

Disponible des:

Dopharma Research B.V.

Codi ATC:

QJ01MA90

Designació comuna internacional (DCI):

Enrofloxacin

Dosis:

100 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle, Pigs

Área terapéutica:

enrofloxacin

indicaciones terapéuticas:

Antibacterial

Estat d'Autorització:

Authorised

Data d'autorització:

2014-10-10

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DORAFLOX 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear slightly yellowish solution.
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 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._
Each ml contains:
Active substance
Enrofloxacin
100 mg
Excipients
Benzyl alcohol
7.8 mg
Disodium edetate
10
mg
For the full list of excipients, see section 6.1.
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