KARIFLOX 100 mg/ml Oral Solution for Chickens and Turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Laboratorios Karizoo S.A.

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Turkeys

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-09-12

Summary of Product characteristics

Health Products Regulatory Authority
19 July 2018
CRN000YMT
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
KARIFLOX 100 mg/ml Oral Solution for Chickens and Turkeys.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Enrofloxacin
100​
mg​
​
EXCIPIENTS:
​
​
​
Benzyl alcohol (E 1519)
14​
mg​
​
For a full list of excipients, see section 6.1
​
​
3 PHARMACEUTICAL FORM
Oral solution.
An aqueous, clear, yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens and Turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by the following bacteria susceptible
to enrofloxacin:
CHICKENS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Avibacterium paragallinarum,_
_Pasteurella multocida._
TURKEYS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida._
4.3 CONTRAINDICATIONS
Do not use in birds producing eggs for human consumption.
Do not use for prophylaxis.
Health Products Regulatory Authority
19 July 2018
CRN000YMT
Page 2 of 7
Do not use when resistance / cross-resistance to (fluoro) quinolones
is known to
occur in the flock intended for treatment.
Refer to section 4.5.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of _Mycoplasma_ spp. infections may not eradicate the
organism.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Since enrofloxacin was first authorised for use in poultry, there has
been widespread
reduction in the susceptibility of _E.coli _to fluoroquinolones and
emergence of
resistant organisms. Resistance has also been reported in _Mycoplasma
synoviae _in the
EU.
Before use, header tanks should be emptied, thoroughly cleaned and
then filled with
a known volume of clean water before adding the required amount of
product. The
resulting mixture should be stirred.
Before use, header tanks should be