Unisol 100 mg/ml Oral 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:

2010-02-26

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
Unisol 100 mg/ml Oral Solution for use in drinking water for chickens
and turkeys.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin..........................................................
100.0 mg
EXCIPIENTS:
Benzyl Alcohol (E 1519)......................................... 14.0
mg
F
or a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral 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._
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.
Health Products Regulatory Authority
19 July 2018
CRN000YNC
Page 2 of 6
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