Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
The veterinary medicinal product is to be used at the maximum recommended dose of 3 mg/kg/day for 10 consecutive days for the treatment of Raillietina echinobothrida which is encountered in free-ranging and traditionally reared poultry.
Do not use the veterinary medicinal product at this dose regimen in intensively reared broiler chickens which are unlikely to be infected with Raillietina echinobothrida.
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the veterinary medicinal product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each flock.
Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a flock, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole flock should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific flock should be sought from the responsible veterinarian.
The use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available.
It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test (FECRT). Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.
Special precautions for use
i). Special precautions for use in animals
The safety of the veterinary medicinal product at overdose has not been evaluated in chickens of less than 14 days of age and in pheasants of less than 3 weeks of age.
ii). Special precautions to be taken by the person administering the veterinary 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 veterinary medicinal product may cause eye irritation.
- Contact with the skin and the eyes or accidental ingestion of the veterinary medicinal product should be avoided.
- Do not smoke, eat or drink when handling the veterinary medicinal product.
- 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.
iii). Other precautions
The veterinary medicinal product should not enter water courses as fenbendazole may be dangerous for fish and other aquatic organisms.
Withdrawal periods
Chickens:
Meat and offal: 6 days for the dosage 1 and 2 mg fenbendazole/kg body weight/day 8 days for the dosage 3 mg fenbendazole/kg body weight/day
Eggs: zero days
Pheasants:
Meat and offal: 6 days
Do not release pheasants for hunting for at least 6 days after the end of medication.
Eggs: zero days