BAYTRIL 2.5 % SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2017
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Active ingredient:
ENROFLOXACIN
Available from:
Bayer Limited
ATC code:
QJ01MA90
INN (International Name):
ENROFLOXACIN
Dosage:
2.5 %w/v
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Avian, Canine, Feline, Gerbils, Hamsters, Rabbits, Reptile
Therapeutic area:
Enrofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1988-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril 25 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml solution contains:
ACTIVE SUBSTANCE:
Enrofloxacin
25 mg
EXCIPIENT:
n-Butyl alcohol
30 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear light-yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats, pigs (piglets), 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.
Pigs (piglets)
Treatment
of infections of the respiratory tract
caused by enrofloxacin susceptible strains of:
_Pasteurella multocida,_
_Mycoplasma_ spp_., Actinobacillus pleuropneumoniae_.
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_.
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
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