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

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Enrofloxacin

Inapatikana kutoka:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC kanuni:

QJ01MA90

INN (Jina la Kimataifa):

Enrofloxacin

Dawa fomu:

Solution for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cats, Cattle, Dogs, Pigs

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Authorized

Idhini ya tarehe:

2010-04-07

Tabia za bidhaa

Revised: August 2015
AN: 00612/2015
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenoflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and
Cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
50mg
EXCIPIENT:
n-butanol
30mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear light yellow solution free from particulate matter.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves), Pigs, Dogs and Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE 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._
Dogs:
Revised: August 2015
AN: 00612/2015
Page 2 of 7
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 alimentary, respiratory and urogenital
tracts (as
adjunctive antibiotic th