LANFLOX 100 mg/ml Solution for use in drinking water for Chickens and Turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Vetpharma Animal Health, S.L.

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for use in drinking water

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:

2010-04-30

Summary of Product characteristics

Health Products Regulatory Authority
19 July 2018
CRN000YNC
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
LANFLOX 100 mg/ml Solution for use in drinking water 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
Solution for use in drinking water.
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._
TURKEY
_Mycoplasma gallisepticum, _
_Mycoplasma synoviae, _
_Pasteurella multocida._
Health Products Regulatory Authority
19 July 2018
CRN000YNC
Page 2 of 6
4.3 CONTRAINDICATIONS
Do not use in birds producing eggs for human consumption.
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.
Do not use in cases of hypersensitivity to the active substanceor 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 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 stirr