Enrocare 25 mg/ml Solution for Injection for Dogs, Cats, Rabbits, Rodents, Reptiles and Ornamental birds

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Emdoka bvba

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

enrofloxacin

Authorization status:

Authorised

Authorization date:

2013-09-27

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2019
CRN008W34
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrocare 25 mg/ml Solution for Injection for Dogs, Cats, Rabbits,
Rodents, Reptiles and Ornamental birds
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:MG
Enrofloxacin 25
EXCIPIENTS:
Butyl alcohol as antimicrobial preservative 30
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear light yellow, sterile, aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats, rabbits, rodents, reptiles and 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_. _
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.
Rabbits
Treatment of infections of the alimentary and respiratory tracts
caused by enrofloxacin susceptible strains of: _Escherichia coli_,
_Pasteurella multocida _and _Staphylococcus _spp.
Treatment of skin and wound infections caused by enrofloxacin
susceptible strains of _Staphylococcus aureus. _
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 CONTRAINDIC