Target species
Pigs
Indications for use, specifying the target species
Treatment of pigs infected with Ascaris suum (adult, intestinal and migrating larval stages).
Contraindications
Do not use in cases of hypersensitivity to the active substance or to 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 veterinary medicinal 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 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.
Personal protective equipment consisting of goggles and impervious gloves should be worn when handling the veterinary medicinal product or preparing medicated drinking water.
In case of accidental ingestion, rinse mouth with plenty of clean water and seek medical advice immediately and show the package leaflet or label to the physician. 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.
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:
Administration of fenbendazole (500 mg/kg) to sows between days 8 and 33 of pregnancy produced no foetal effects. 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.
Amount(s) to be administered and administration route
In drinking water use. Shake well before use.
To ensure a correct dosage, body weight should be determined as accurately as possible. Before allowing animals to have access to the medicated water, the water delivery system should be drained, if possible, and flushed with the medicated water to ensure accuracy of dosing. This procedure may need to be performed on all treatment days.
The dose is 2.5 mg fenbendazole per kg body weight per day (equivalent to 0.0125 ml veterinary medicinal product per kg body weight per day). This dose has to be administered on 2 consecutive days.
Dose calculation:
Based on the recommended dose and the number and weight of animals to be treated, the exact daily dose of the veterinary medicinal product should be calculated according to the following formula:
ml veterinary medicinal product/day = total estimated body weight (kg) of pigs to be treated x 0.0125 ml
The intake of medicated water 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 each treatment day the medicated water needs to be freshly prepared. Follow the instructions described below to prepare the medicated water. Use a sufficiently accurate commercially available measuring device.
For use in medication tank:
Add the calculated amount of veterinary medicinal product to the volume of drinking water usually consumed by the animals over 6 hours. Stir until content in the medication tank is visibly homogeneous. The medicated water appears hazy. No further stirring during administration is necessary.
For use in dosing pump:
Add the calculated amount of veterinary medicinal product to the unmedicated water in the stock suspension container of the dosing pump. The volume of unmedicated water in the stock suspension container has to be calculated taking into account the preset injection rate of the dosing pump and the volume of drinking water usually consumed by the animals over 6 hours. Stir until content in the stock suspension container is visibly homogeneous. The medicated water appears hazy.
During treatment all animals must have solely but unrestricted access to the medicated water.
During treatment, after complete consumption of the medicated water, animals must be allowed access to un-medicated drinking water as soon as possible.
Ensure that the total amount of medicated water offered is consumed.
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
Meat and offal: 4 days.