Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Enrofloxacin

Available from:

Chanelle Pharmaceuticals Manufacturing Ltd

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2010-04-07

Summary of Product characteristics

Revised: August 2015
AN: 00612/2015
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenoflox 100 mg/ml Solution for Injection for Cattle and Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100mg
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 and Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of bacterial infections caused by strains susceptible to
enrofloxacin.
CATTLE
Treatment of infections of the 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 _in cattle less than 2 years old.
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 urinary tract caused by enrofloxacin
susceptible strains
of _Escherichia coli. _
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome)
caused by
enrofloxacin susceptible strains of _Escherichia coli _and _Klebsiella
_spp.
Revised: August 2015
AN: 00612/2015
Page 2 of 6
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_.
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use when resistance / cross resistance to (Fluoro)quinolones is
known to
occur. Refer to secti