Target species
Pigs
Indications for use
Treatment of pigs infected with Ascaris suum (adult and migrating larval stages) susceptible to fenbendazole.
Contraindications
Do not use in known cases of hypersensitivity to the active substance, other benzimidazoles or any of the excipients.
Special warnings 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.
Accidental ingestion of the veterinary medicinal product should be avoided.
In case of accidental ingestion, rinse mouth with plenty of clean water, seek medical advice immediately and show the package leaflet or the label to the physician.
This veterinary medicinal product may cause eye irritation and skin sensitisation.
Avoid contact with skin and/or eyes.
Personal protective equipment consisting of goggles, impervious gloves and a disposable half-mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143 should be worn when handling the veterinary medicinal product.
In case of skin and/or eye contact, immediately rinse with plenty of water.
Wash hands after use.
Special precautions for the protection of the environment
The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Other precautions
Not applicable
Adverse reactions (frequency and seriousness)
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy.
The safety of the veterinary medicinal product has not been established during lactation. Use only 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.
Amounts to be administered and administration route
Oral use.
The veterinary medicinal product is only intended for the treatment of individual pigs on farms where a small number of pigs are to receive treatment.
To be mixed with a small quantity (20%) of the daily feed ration and administered prior to offering the remaining feed.
The treated feed must be prepared daily just before administration to the animals.
Pigs to be treated should be separated and treated individually.
May be administered to pigs using the following dosage regimens:
- Single dose of 5 mg fenbendazole (corresponding to 125 mg of the product) per kg bodyweight (migrating larval, intestinal larval and adult stages);
- 0.72 mg fenbendazole (corresponding to 18 mg of the product) per kg bodyweight per day for 7 consecutive days (intestinal larval and adult stages);
- 0.36 mg fenbendazole (corresponding to 9 mg of the product) per kg bodyweight per day for 14 consecutive days (intestinal larval and adult stages).
To ensure a correct dosage, body weight should be determined as accurately as possible.
The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of fenbendazole may need to be adjusted accordingly.
The use of suitably calibrated measuring equipment is recommended.
Partly-consumed feed must be disposed of with other waste feed and not given to other animals.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The veterinary medicinal product administered as a single 25 mg fenbendazole/kg dose for three consecutive days did not produce any clinically apparent adverse reactions in pigs.
Withdrawal periods
Meat and offal: 4 days