Coccibal, 200 mg/ml Solution for Use in Drinking Water for Chicken and Turkeys

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Amprolium

Fáanlegur frá:

SP Veterinaria, S.A.

ATC númer:

QP51AX09

INN (Alþjóðlegt nafn):

Amprolium

Lyfjaform:

Oral solution

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Chickens, Turkeys

Lækningarsvæði:

Antiprotozoal coccidiostat

Leyfisstaða:

Authorized

Leyfisdagur:

2012-04-11

Vara einkenni

Revised: February 2023
AN: 01022/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coccibal, 200 mg/ml solution for use in drinking water for chickens
and turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Amprolium 200 mg
(equivalent to 226.2 mg Amprolium Hydrocloride)
Excipients:
Sodium methyl parahydroxybenzoate (E219) 1 mg
Sodium propyl parahydroxybenzoate 0.2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (broilers, pullets, layers, breeder hens) and turkeys
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Chickens (broilers, pullets, layers, breeder hens) and turkeys:
treatment of intestinal
coccidiosis caused by _Eimeria_ spp susceptible to amprolium.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
Revised: February 2023
AN: 01022/2022
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with any antiparasiticide, frequent and repeated use of
antiprotozoals from the
same class may lead to the development of resistance.
In case of detection a lack of efficacy during treatment, communicate
it to the national
competent authorities.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The product is not intended for preventive use.
This product should be reserved for use 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.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
This product is acidic and may cause irritation to, or corrosion of,
the skin, eyes,
throat and airways.
Avoid all physical contact with the product, including any vapours.
Do not eat, drink or smoke whilst handling