Coccibal 400 mg/ml solution for use in drinking water for chickens and turkeys

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Amprolium hydrochloride

Disponível em:

SP Veterinaria, S.A.

Código ATC:

QP51AX09

DCI (Denominação Comum Internacional):

Amprolium hydrochloride

Dosagem:

400 milligram(s)/millilitre

Forma farmacêutica:

Solution for use in drinking water

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapêutica:

amprolium

Status de autorização:

Authorised

Data de autorização:

2021-02-26

Características técnicas

Health Products Regulatory Authority
01 March 2021
CRN009HDQ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Coccibal 400 mg/ml solution for use in drinking water for chickens and
turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
​
Amprolium
​
400 mg
(equivalent to 452.4 mg Amprolium Hydrochloride)
​
EXCIPIENTS:
​
​
Sodium methyl parahydroxybenzoate (E-219)
​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 yellowish 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
Treatment of intestinal coccidiosis caused by _Eimeria _spp
susceptible to Amprolium.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with any antiparasiticide, frequent and repeated use of
antiprotozoal agents of the same class can lead to resistance
development.
In case of detection of 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 this product. Wear
impervious gloves and protect