Amprol 12% w/v Solution for Use in Drinking Water

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Amprolium Hydrochloride

Fáanlegur frá:

Pharmsure International Ltd

ATC númer:

QP51AX09

INN (Alþjóðlegt nafn):

Amprolium Hydrochloride

Lyfjaform:

Solution for use in drinking water

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Chickens, Turkeys

Lækningarsvæði:

Antiprotozoal coccidiostat

Leyfisstaða:

Expired

Leyfisdagur:

2016-06-14

Vara einkenni

Amended pages July 2016
AN: 00696/2011
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amprol 12% w/v Solution for use in drinking water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains:
Qualitative composition
Quantitative composition
Amprolium hydrochloride
120 mg (equivalent to 106 mg
amprolium)
Sorbic acid (E200)
1 mg
3.
PHARMACEUTICAL FORM
Solution for use in drinking water
The solution is clear, yellow in colour.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers, pullets, layers, breeder hens) and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of intestinal coccidiosis caused by Eimeria spp
susceptible to
amprolium.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with all anticoccidials, prolonged use may result in the
development of
resistant strains. Use of anticoccidial drugs having the same mode of
action
should be avoided due to the development of cross-resistance.
Amended pages July 2016
AN: 00696/2011
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
The product is not intended for a preventive use.
This product should be reserved in case of coccidiosis outbreaks due
to
non-availability of vaccine, in case of lack of efficacy of vaccine
and in
vaccinated flocks if a severe coccidial challenge is diagnosed before
immunity has fully developed.
ii)
Special precautions for the person administering the veterinary
medicinal
product to animals
This is an irritant and corrosive product. It could cause airway, eye
and
skin irritation. Wear impervious gloves and protective glasses when
handling the product.
The selected protective gloves have to satisfy the specifications of
EU
Directive 89/686/EEC and the standard EN 374 derived from it.
Avoid inhalation of vapours.
Avoid contact with the skin and eyes. In the case of contact with skin
or
eyes, wash th