Quinoflox 100 mg/ml Solution for Use in Drinking Water, Chicken and Rabbits

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Enrofloxacin

Available from:

Global Vet Health S.L.

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Pharmaceutical form:

Solution for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Rabbits

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2011-08-15

Summary of Product characteristics

Revised: July 2018
AN: 00239/2018
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Quinoflox 100 mg/ml solution for use in drinking water for chickens
and rabbits
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the product contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENTS:
Benzyl alcohol (E 1519) 14.6 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Chickens (Broilers, replacement chickens, broiler breeders) and
rabbits
4.2.
INDICATIONS FOR USE
Chickens (Broilers, replacement chickens, broiler breeders):
Treatment of infections caused by the following bacteria susceptible
to enrofloxacin:
_Mycoplasma gallisepticum_,
_Mycoplasma synoviae_,
_Avibacterium paragallinarum_,
_Pasteurella multocida_
Rabbits: Treatment of respiratory infections caused by _ P. multocida
_ susceptible to
enrofloxacin.
Where clinical experience, supported where possible by sensitivity
testing of the
causal organism, indicates enrofloxacin as the drug of choice.
4.3.
CONTRAINDICATIONS
Do not use in case of renal and hepatic failure.
Do not treat animals with cartilaginous growth disturbance.
Do
not
use
in
case
of
known
hypersensitivity
to
the
active
substance,
other
(fluoro)quinolones or to any of the excipients.
Revised: July 2018
AN: 00239/2018
Page 2 of 7
Do not use for prophylaxis.
Do not use when resistance/ cross-resistance to (fluoro)quinolones is
known to occur
in the flock intended for treatment.
See section 4.11
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of _Mycoplasma spp _infections may not eradicate the
organism.
4.5.
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Since
enrofloxacin
was
first
authorised
for
use
in
poultry,
there
has
been
widespread
reduction
in
susceptibility
of
_E.coli _
to
fluoroquinolones
and
emergence
of
resistant
organisms.
Resistance
has
also
been
reported
in
_Mycoplasma synoviae _in the