Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Enrofloxacin

Διαθέσιμο από:

Chanelle Pharmaceuticals Manufacturing Limited

Φαρμακολογική κατηγορία (ATC):

QJ01MA90

INN (Διεθνής Όνομα):

Enrofloxacin

Δοσολογία:

50 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Bovine, Canine, Feline, Porcine

Θεραπευτική περιοχή:

enrofloxacin

Θεραπευτικές ενδείξεις:

Antibacterial

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2010-07-16

Αρχείο Π.Χ.Π.

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and
Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
50 mg
EXCIPIENT:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
n-butanol
_ _
30 mg
Potassium hydroxide, (for pH adjustment)
_ _
_ _
Water for injections
_ _
_ _
Clear light yellow solution for injection free from particulate
matter.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (calves), Pigs, Dogs and Cats.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Calves:
Treatment of infections of respiratory tract caused by enrofloxacin
susceptible strains of
_Pasteurella _
_multocida, Mannheimia haemolytica _
and
_ Mycoplasma _
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_
.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin
susceptible strains of
_Mycoplasma bovis. _
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 alimentary tract caused by enrofloxacin
susceptible strains of
_Escherichia coli. _
Treatment of septicaemia caused by enrofloxacin susceptible strains of
_Escherichia_
_coli_
.
3
Dogs:
Treatment of infections of the alimentary, respiratory and urogenital
tracts (including prostatitis,
adjunctive antibiotic therapy for pyometra), skin and wound infections
and 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 ali