DORAFLOX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-06-2016
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Active ingredient:
ENROFLOXACIN
Available from:
Dopharma Research B.V.
ATC code:
QJ01MA90
INN (International Name):
ENROFLOXACIN
Dosage:
100 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Enrofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2014-10-10
Summary of Product characteristics
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
3 PHARMACEUTICAL 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.
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._
Each ml contains:
Active substance
Enrofloxacin
100 mg
Excipients
Benzyl alcohol
7.8 mg
Disodium edetate
10 mg
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY A
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