Enrotron 25 mg/ml Solution for Injection for Dogs, Cats, Rodents, Reptiles and Ornamental Birds

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Enrofloxacin

Fáanlegur frá:

aniMedica GmbH

ATC númer:

QJ01MA90

INN (Alþjóðlegt nafn):

Enrofloxacin

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats, Dogs, Ornamental Birds, Reptiles, Rodents

Lækningarsvæði:

Antimicrobial

Leyfisstaða:

Authorized

Leyfisdagur:

2012-03-06

Vara einkenni

Revised: February 2019
AN: 01476/2018
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_._
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_._
Revised: February 2019
AN: 01476/2018
Page 2 of 7
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 in animals that are epileptic or suffer from