Enrotron 25 mg/ml Solution for injection for dogs, cats, rodents, reptiles and ornamental birds

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Enrofloxacin

Disponible des:

aniMedica GmbH

Codi ATC:

QJ01MA90

Designació comuna internacional (DCI):

Enrofloxacin

Dosis:

25 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

enrofloxacin

Estat d'Autorització:

Authorised

Data d'autorització:

2012-04-20

Fitxa tècnica

Health Products Regulatory Authority
11 February 2019
CRN008V5C
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotron 25 mg/ml Solution for injection for dogs, cats, rodents,
reptiles and
ornamental birds
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Enrofloxacin 25.0 mg
EXCIPIENTS
1-Butanol 30.0 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellowish to yellowish orange solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
Cats
Rodents
Reptiles
Ornamental birds
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
DOGS
Treatment of infections of the alimentary, respiratory and urogenital
tracts (including
prostatitis, adjunctive antibiotic therapy for pyometra), skin and
wound infections,
otitis (externa/media) caused by enrofloxacin susceptible strains of:
_Staphylococcus _
spp_., Escherichia coli, Pasteurella _spp_., Klebsiella _spp_.,
Bordetella _spp_., Pseudomonas _
spp_. _and _Proteus _spp_._
Health Products Regulatory Authority
11 February 2019
CRN008V5C
Page 2 of 7
CATS
Treatment of infections of the alimentary, respiratory and urogenital
tracts (as
adjunctive antibiotic therapy for pyometra), skin and wound
infections, caused by
enrofloxacin susceptible strains of: _Staphylococcus _spp_.,
Escherichia coli, Pasteurella _
spp_., Klebsiella _spp_., Bordetella _spp_., Pseudomonas _spp_. _and_
Proteus _spp_._
RODENTS, REPTILES AND ORNAMENTAL BIRDS
Treatment of infections of the alimentary and respiratory tracts where
clinical
experience, if possible, supported by susceptibility testing of the
causal organism,
indicates enrofloxacin as the substance of choice.
4.3 CONTRAINDICATIONS
Do not use in dogs less than 1 year of age or in exceptionally large
breeds of dog
with a longer growth period under 18 months of age.
Do not use for cats less than 8 weeks of age.
Do not use in cases of known hypersensitivity to fluoroquinolones or
to any of the
excipients.
Do not use