Do not use in known cases of hypersensitivity to the active substance or to any of the excipients
Special warning for each target species
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
•Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
•Under dosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
Special precautions for use
Special precautions for use in animals:
None.
Special precautions to be taken by the person administering the medicinal product to animals:
Embryotoxic effects cannot be excluded. Pregnant women must take extra precautions when handling this veterinary medicinal product.
This veterinary medicinal product may be toxic to humans after ingestion.
This product may cause eye irritation.
Contact with the skin and the eyes or accidental ingestion of the product should be avoided.
Do not smoke, eat or drink when handling the veterinary medicinal product.
Wear goggles and impervious gloves to avoid direct skin and eye contact with the product when handling or preparing medicated drinking water.
In the event of accidental ingestion, rinse mouth with plenty of clean water and seek medical advice. In the event of accidental contact with the skin or eyes, rinse with plenty of clean water and seek medical advice.
Wash hands after use.
Other precautions:
The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
Administration of fenbendazole (500 mg/kg) to sows between days 8 and 33 of pregnancy produced no foetal effects. The safety of the product has not been established during lactation. Use according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Exacerbation of paracetamol hepatotoxicity by fenbendazole cannot be excluded.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No undesirable effects have been observed in pigs at up to 5 times the recommended dose.
Withdrawal Periods
Pigs: 4 days.