Target species
Pigs
Indications for use, specifying the target species
Treatment of pigs infected with Ascaris suum (adult, intestinal 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.
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed, animals should be treated parenterally.
Special precautions for use
Special precautions for use in animals
None
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.
Accidental ingestion of the veterinary medicinal product should be avoided.
In case of accidental ingestion, rinse mouth with plenty of clean water and 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
For oral administration. In-feed use.
The veterinary medicinal product is suitable for herd medication of pigs.
Administer at a dose rate of 5 mg fenbendazole per kg bodyweight. May be administered to pigs either as a single dose of 5 mg/kg (migrating larval, intestinal larval and adult stages) or by divided dose of 0.72 mg/kg over 7 days (intestinal larval and adult stages) or 0.36 mg/kg over 14 days (intestinal larval and adult stages).
Single dose treatment
Use the following formula to calculate how much product to add per tonne of feed:
Single dose treatment
Kg veterinary medicinal product per tonne = | Bodyweight (kg) |
| (Daily feed intake (kg) x 8) |
7 day treatment
The standard dose rate can be divided and administered in feed over 7 days. Use the following formula to calculate how much product to add per tonne of feed:
Kg veterinary medicinal product per tonne = | Bodyweight (kg) |
| (Daily feed intake (kg) x 56) |
14 day treatment
The standard dose rate can be divided and administered in feed over 14 days. Use the following formula to calculate how much product to add per tonne of feed:
Kg veterinary medicinal product per tonne = | Bodyweight (kg) |
| (Daily feed intake (kg) x 112) |
To ensure a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.
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.
For incorporation into dry feed at the registered mill.
A manufacturer who is approved to incorporate veterinary medicinal products, or premixtures containing such veterinary medicinal products, directly at any concentration, must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed
To ensure adequate distribution of the veterinary medicinal product in the final feed it is recommended to premix the veterinary medicinal product at a ratio of 1:10 with feed ingredients before blending into the final feed.
If the premix is used for supplementation of pelleted feed, the pelleting temperature should not exceed 85 °C.
Not to be mixed in liquid feed.
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. In addition, it has been shown that administration of non-formulated fenbendazole at a dose of 2000 mg/kg for 14 consecutive days was well tolerated in pigs.
Withdrawal periods
Meat and offal: 4 days