Doraflox 100 mg/ml Solution for Injection for Cattle and Pigs
Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Summary of Product characteristics
(SPC)
20-07-2021
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Active ingredient:
Enrofloxacin
Available from:
Dopharma Research B.V.
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:
Expired
Authorization date:
2011-06-27
Summary of Product characteristics
Revised: May 2016
AN: 00762/2015
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DORAFLOX 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Enrofloxacin
100 mg
Excipients
Benzyl alcohol
Disodium edetate
7.8 mg
10 mg
For the full list of excipients, see section 6.1.
3.
PHARMAPEUTICAL FORM
Solution for injection.
Clear slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible
strains of _Pasteurella multocida_, _Mannheimia haemolytica_ and
_Mycoplasma spp_.
Treatment of acute severe mastitis caused by enrofloxacin susceptible
strains of
_Escherichia coli._
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.
Revised: May 2016
AN: 00762/2015
Page 2 of 7
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_.
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
CONTRA-INDICATIONS
Do not use in growing horses because of possible deleterious damage on
articular
cartilage.
Do not use for prop
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