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Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substance or to the excipient.
Special warnings for each target species:
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.
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 to be taken by the person administering the 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 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.
iii) Other precautions
Amprolium is classified as a persistent substance in soil.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
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.
Interaction with other medicinal products and other forms of interaction
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
A prolonged use at high doses can produce thiamine deficiency. This deficiency can be compensated by a thiamine intake.