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

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

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Prenos Lastnosti izdelka (SPC)
11-05-2024

Aktivna sestavina:

Enrofloxacin

Dostopno od:

Krka d.d., Novo Mesto

Koda artikla:

QJ01MA90

INN (mednarodno ime):

Enrofloxacin

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Cattle, Dogs, Pigs

Terapevtsko območje:

Antimicrobial

Status dovoljenje:

Authorized

Datum dovoljenje:

2006-03-15

Lastnosti izdelka

                                Revised: May 2024
AN: 00504/2023
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
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
n-butyl alcohol
30 mg
Potassium hydroxide
Water for injections
Clear yellow solution practically free from particles.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle (calves), pigs and dogs.
3.2
INDICATIONS FOR USE FOR EACH 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_
Revised: May 2024
AN: 00504/2023
Page 2 of 8
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.
3.3
CONTRAINDICA
                                
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