ENROXIL 50 mg/ml solution for injection for calves, pigs and dogs

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Enrofloxacin

Commercializzato da:

Krka, d.d., Novo mesto

Codice ATC:

QJ01MA90

INN (Nome Internazionale):

Enrofloxacin

Dosaggio:

50 milligram(s)/millilitre

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Cattle, Pigs

Area terapeutica:

enrofloxacin

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2009-07-10

Scheda tecnica

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
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution practically free from particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, 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.
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.
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