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

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Enrofloxacin

Dostupno od:

Krka, d.d., Novo mesto

ATC koda:

QJ01MA90

INN (International ime):

Enrofloxacin

Doziranje:

50 milligram(s)/millilitre

Farmaceutski oblik:

Solution for injection

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Cattle, Pigs

Područje terapije:

enrofloxacin

Terapijske indikacije:

Antibacterial

Status autorizacije:

Authorised

Datum autorizacije:

2009-07-10

Svojstava lijeka

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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_