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

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Enrofloxacin

Verfügbar ab:

Krka d.d., Novo Mesto

ATC-Code:

QJ01MA90

INN (Internationale Bezeichnung):

Enrofloxacin

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cattle, Dogs, Pigs

Therapiebereich:

Antimicrobial

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2006-03-15

Fachinformation

Revised: May 2024
AN: 00506/2023
Page 1 of 8
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
Each ml 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
Cattle (calves), pigs and 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.,
Revised: May 2024
AN: 00506/2023
Page 2 of 8
_Escherichia coli_, _Pasteurella_ spp., _Klebsiella_ spp.,
_Bordetella_ spp., _Pseudomonas_ spp. and
_Proteus_ spp.
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use in case of resistance against quinolones.