ENRO-K 100 mg/ml Solution for use in drinking water

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Enrofloxacin

Disponibbli minn:

Laboratorios Karizoo S.A.

Kodiċi ATC:

QJ01MA90

INN (Isem Internazzjonali):

Enrofloxacin

Dożaġġ:

100 milligram(s)/millilitre

Għamla farmaċewtika:

Oral solution

Tip ta 'preskrizzjoni:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupp terapewtiku:

Chickens, Turkeys

Żona terapewtika:

enrofloxacin

Indikazzjonijiet terapewtiċi:

Antibacterial

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2009-08-28

Karatteristiċi tal-prodott

Health Products Regulatory Authority
30 July 2018
CRN000YMW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ENRO-K 100 mg/ml Solution for use in drinking water
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of ENRO-K 100 mg/ml Solution for use in drinking water
contains:
ACTIVE SUBSTANCE:
Enrofloxacin 100 mg
EXCIPIENTS:
Benzyl Alcohol (E 1519) 14 mg
For the 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._
TURKEYS
_Mycoplasma gallisepticum,_
_Mycoplasma synoviae,_
_Pasteurella multocida._
Health Products Regulatory Authority
30 July 2018
CRN000YMW
Page 2 of 7
Enrofloxacin should be used where clinical experience, supported where
possible by
sensitivity testing of the causal organism, indicates enrofloxacin as
the active
substance of choice.
4.3 CONTRAINDICATIONS
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 known hypersensitivity to the active substance,
other
(fluoro)quinolones 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
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 inspected at regular intervals for
presence of dust,
algae formation and sedimentation.
Official and local antimicrobia