Enroxil 50 mg/ml Solution for Injection for Calves, Pigs and Dogs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Enrofloxacin

Commercializzato da:

Krka d.d., Novo Mesto

Codice ATC:

QJ01MA90

INN (Nome Internazionale):

Enrofloxacin

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Cattle, Dogs, Pigs

Area terapeutica:

Antimicrobial

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2006-03-15

Scheda tecnica

Revised: January 2015
AN: 01130/2014
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ENROXIL 50 mg/ml solution for injection for calves, pigs and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Enrofloxacin
50 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
Calves, pigs, dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves:
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_.
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:
Treatment of infections of the alimentary, respiratory and urogenital
tracts (including
prostatitis, adjunctive antibiotic therapy for pyometra), skin and
wound infections, otitis
(externa/media) caused by enrofloxacin susceptible strains of
_Staphylococcus _spp.,
_Escherichia coli_, _Pasteurella _spp., _Klebsiella _spp., _Bordetella
_spp., _Pseudomonas _spp. and
_Proteus _spp.
Revised: January 2015
AN: 01130/2014
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use in cases of resistance ag