Unisol 100 mg/ml Oral Solution for use in Drinking Water for Chickens and Turkeys

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Enrofloxacin

Available from:

Vetpharma Animal Health, S.L

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Authorization status:

Expired

Summary of Product characteristics

Issued 17/06/2010 – AN 00928/2009
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
mg
EXCIPIENTS:
Benzyl Alcohol (E 1519)....................14
mg
For 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
For the treatment of diseases of the respiratory tract due to
_Escherichia coli_ or/
and _Mycoplasma gallisepticum_, where clinical experience and/or
sensitivity
testing indicates enrofloxacin as the drug of choice.
4.3.
CONTRAINDICATIONS
Do not use in birds producing eggs for human consumption.
Do not use for prophylaxis.
Do not use in cases of confirmed, or suspected, resistance to
quinolones.
Do not use in cases of hypersensitivity to the active substance.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
1/6
Issued 17/06/2010 – AN 00928/2009
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 antimicrobial policies should be taken into account
when the
product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions
which have responded poorly, or are expected to respond poorly, to
other
classes of antimicrobials.
Wherever possible, fluoroquinolones should be used based on
susceptibility
testing.
Use of the product deviating from instructions given in the SPC may
increase
the prevalence of bacteria resis