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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

GLOBAL VET HEALTH SL

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-01-11

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Quinoflox 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100.0 mg
EXCIPIENTS:
QUALITATIVE COMPOSITION OF
EXCIPIENTS AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCt
Benzyl alcohol
0.02 ml
Lactic acid
Disodium edetate
Water for injections
Clear yellow solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle and pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
CATTLE
Treatment
of
infections
of
the
respiratory
tract
caused
by
_ _
_Mannheimia _
_haemolytica, Mycoplasma _spp and_ Pasteurella multocida_.
Treatment of infections of the alimentary tract caused by _Escherichia
coli_.
Treatment of septicaemia caused by _Escherichia coli_.
Treatment of acute mycoplasma-associated arthritis due to _Mycoplasma
bovis _
in cattle less than 2 years old.
PIGS
Treatment
of
infections
of
the
respiratory
tract
caused
by
_Actinobacillus _
_pleuropneumoniae, Mycoplasma _spp. and_Pasteurella multocida . _
Treatment of infections of the urinary tract caused by _Escherichia
coli. _
Treatment
of
post-partum
dysgalactiae
syndrome,
PDS
(MMA
syndrome)
caused by _Escherichia coli _and _Klebsiella _spp.
Treatment of infections of the alimentary tract caused by _Escherichia
coli_.
Treatment of septicaemia caused by _Escherichia coli_.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in growing horses because of possible deleterious damage on
articular cartilage.
Do
not
use
in
animals
with
central
nervous
system-associated
seizure
disorders.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Degenerative changes of articular cartilage were observed in calves
treated
orally with 30 mg enrofloxacin/kg bw during 14 days.
Do not use in the presence of existing disorders o