Contraindications:
Do not use in cases of hypersensitivity to the active substance or to the excipient.
Special warnings for each target species:
As with any antimicrobial, frequent and repeated use of antiprotozoal agents of the same class can lead to resistance development. Cross-resistance has been shown between amprolium and anticoccidial drugs having the same mode of action. Use of the veterinary medicinal product/amprolium should be carefully considered when susceptibility testing has shown resistance to amprolium/anticoccidials because its effectiveness may be reduced. As with all anticoccidials, prolonged use may result in the development of resistant strains. 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 veterinary medicinal product is not intended for prophylaxis. This veterinary medicinal 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. Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level. Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
ii) Special precautions to be taken by the person administering the medicinal product to animals
This veterinary medicinal 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. People with known hypersensitivity to amprolium or to sorbic acid should avoid contact with the veterinary medicinal product. Wash hands and exposed skin after use.
iii) Special precautions for the protection of the environment
Amprolium is classified as a very persistent substance in soil.
iv) Other precautions
Not applicable
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Laboratory studies have not produced any evidence of teratogenic effects. The safety of amprolium has not been established in laying birds. Laying birds: Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Amprolium is a thiamine analogue. Therefore, the efficacy of amprolium may be reduced during a simultaneous administration of products containing vitamin Bcomplex.
Overdose (symptoms, emergency procedures, antidotes), if necessary
A prolonged use at high doses can produce thiamine deficiency. This deficiency can be compensated for by an appropriate thiamine intake.