Solution for use in drinking water. Clear and yellow solution.

Each mL contains:

Active substance: Amprolium 400.0 mg (equivalent to amprolium hydrochloride 452.4 mg)

Excipients: Sorbic acid (E200) 0.5 mg

Chickens (broilers, pullets, layers and breeder hens), turkeys.

In chickens (broilers, pullets, layers and breeder hens), turkeys:

Treatment of intestinal coccidiosis caused by Eimeria spp susceptible to amprolium.

In drinking water use.

The posology for each target species is 20 mg amprolium / kg body weight / day (equivalent to 0.5 mL of oral solution / 10 kg bodyweight/day) for 5 to 7 consecutive days.

For the preparation of medicated water, the body weight of the animals to be treated and their actual daily water consumption should be taken into account. Consumption may vary depending on factors like age, state of health, breed, and husbandry system. To provide the required amount of veterinary medicinal product in ml per litre drinking water the following calculation should be made:

Sufficient access to the system of water supply should be available for the animals to be treated to ensure adequate water consumption. No other source of drinking water should be available during the medication period. Medicated drinking water should be replaced every 24 hours.

After the end of the medication period the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.

The veterinary medicinal product should not be used in contact with metal pipework or containers.

Chickens and turkeys:

- Meat and offal: zero days

Eggs: zero days

Contraindications:

Do not use in cases of hypersensitivity to the active substance or to the excipient.

As with any antiparasiticide, frequent and repeated use of an antiprotozoal agents of the same class can lead to resistance development. 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. In case of detection of lack of efficacy during treatment, communicate it to competent national authorities.

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.

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 protective glasses when handling the product.

The selected protective gloves should satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

In the case of contact with skin or eyes, wash the affected area with clean running water immediately and remove any contaminated clothes. If irritation persists, seek medical advice and show the label to the physician.

In case of accidental ingestion, rinse the mouth with fresh water, seek medical advice immediately and show the label to the physician

Those with known hypersensitivity to amprolium or to sorbic acid should avoid contact with the product.

Wash hands and exposed skin after use.

Amprolium is classified as a persistent substance in soil.

None known.

Studies in laboratory animals have not produced any evidence of teratogenic effects. The safety of amprolium has not been investigated in laying birds. Use only according to the risk/benefit assessment by the responsible veterinarian.

Amprolium is an anticoccidial belonging to thiamin analogs family. Therefore, the efficacy of amprolium may be reduced during a simultaneous administration of products containing vitamin B-complex.

A prolonged use at high doses can produce thiamine deficiency. This deficiency can be compensated by a thiamine intake.

Pharmacotherapeutic group: antiprotozoals, agents against protozoal diseases, amprolium.

ATCvet code: QP51AX09.

Amprolium is an anticoccidial which belongs to the thiamine analogues family. Amprolium acts by interfering as a competitive antagonist of thiamine within thiamine transport mechanisms. It interferes in the carbohydrate metabolism required for coccidies multiplication and survival.

In in-vitro studies it was shown that the uptake of thiamine by schizonts of Eimeria tenella and by host intestinal cells can occur through passive diffusion or by an active, energy-and pH-dependent process. Amprolium competitively inhibited both systems, however, the parasite was shown to be more sensitive to amprolium than the host.

As shown with Eimeria maxima inoculated chicken, the administration of Amprolium resulted in a proportion of morphologically abnormal macrogametes and oocysts which may be considered the reason for a reduced sporulation rate.

Amprolium is weakly absorbed after oral administration. Maximum plasma drug concentration is reached 4 hours later.

Amprolium is excreted mainly via faeces.

Amprolium is persistent in soil.

Sorbic acid (E200).

Purified water.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Do not store above 30°C.

100 mL can: white and opaque can made of high density polyethylene, closed with a white and opaque cap made of high density polyethylene with a ring and having polyethylene foam inside.

1 and 5 L cans: white and opaque can made of high density polyethylene closed with a purple and opaque cap made of polypropylene and having a tamper-proof ring and a seal made of aluminium/PET/polyethylene.

Not all pack sizes may be marketed.

Shelf life of the veterinary medicinal product as packaged for sale: 24 months

Shelf life after first opening the immediate packaging: 4 months

Shelf life after dilution according to directions: 24 hours

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

HUVEPHARMA SA

34 RUE JEAN MONNET

ZI D'ETRICHE

SEGRE

49500 SEGRE-EN-ANJOU BLEU

FRANCE

Vm 41623/4001