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Contra-indications, warnings, etc
Do not use on an empty stomach. Do not use in cases of established diarrhoea for more than 24 hours and in weak animals. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
As symptoms of toxicity may occur at twice the therapeutic dose, it is necessary to apply the recommended dosage strictly. Symptoms of toxicity include diarrhoea, visible blood in faeces, decline in milk consumption, dehydration, apathy and prostration. Should clinical signs of overdosing occur, the treatment should be stopped immediately and the animal fed unmedicated milk or milk replacer. Rehydration may be necessary.
In very rare cases, an increase in the level of diarrhoea has been observed in treated animals.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Special precautions for use in animals
Administer after colostrum feeding, or after milk or milk replacer feeding only, using an appropriate device for oral administration. For treatment of anorexic calves, the product should be administered in half a litre of an electrolyte solution. The animals should receive enough colostrum according to good breeding practice.
Special precautions to be taken by the person administering the veterinary medicinal product to animals.
This product contains halofuginone, which can cause allergic reactions in some people. People with known hypersensitivity (allergy) to halofuginone or any of the excipients should administer the veterinary medicinal product with caution. Repetitive contact with the product may lead to skin allergies.
The product may be irritating to the skin and eyes and systemic toxicity cannot be excluded in case of contact with the skin.
Avoid skin, eye or mucosal contact with the product.
Personal protective equipment consisting of protective gloves should be worn when handling the veterinary medicinal product.
Wash hands after use.
In case of skin and eye contact wash the exposed area thoroughly with clean water. If you develop symptoms following exposure, such as skin rash or eye irritation, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.