Enroxil 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)
14-06-2023
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Active ingredient:
Enrofloxacin
Available from:
Krka d.d., Novo Mesto
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:
2006-03-15
Summary of Product characteristics
Revised: January 2015
AN: 01130/2014
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ENROXIL 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENT(S):
n-butyl alcohol as antimicrobial preservative
30 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution practically free from particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, 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_.
Revised: January 2015
AN: 01130/2014
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use in cases of resistanc
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