Enroxil 100 mg/ml solution for injection for cattle and pigs

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Enrofloxacin

Tilgængelig fra:

Krka, d.d., Novo mesto

ATC-kode:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosering:

100 milligram(s)/millilitre

Lægemiddelform:

Solution for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

enrofloxacin

Terapeutiske indikationer:

Antibacterial

Autorisation status:

Authorised

Autorisation dato:

2009-07-10

Produktets egenskaber

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
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_.
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.
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