Target species
Pigs
Indications for use
Treatment of pigs infected with Ascaris suum (adult, intestinal and migrating larval stages) susceptible to fenbendazole.
Contra-indications
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.
In appetent animals should be treated individually.
Special precautions for use
i. Special precautions for use in animals
None
ii. Special precautions to be taken by the person administering the medicinal product to animals.
This product may cause eye irritation.
Avoid contact with skin and/or eyes.
When handling or mixing, care should be taken to avoid direct contact with the skin and eyes, and inhalation of dust, by wearing 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.
Wash hands after use.
In case of skin and/or eye contact, immediately rinse with plenty of water.
Do not eat or smoke during handling the premix or the medicated feed.
iii. Other precautions
The veterinary medicinal product should not be allowed to enter surface waters as it has harmful effects on aquatic organisms.
Adverse reactions
None known.
Use during pregnancy, lactation or lay
The product can be safely administered to pregnant animals.
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.
Interactions
Exacerbation of paracetamol hepatotoxicity by fenbendazole cannot be excluded.
Amounts to be administered and administration route
For oral administration. In-feed use.
The product is suitable for herd medication of pigs. Administer at a dose rate of 5mg 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 powder 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 powder 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 powder per tonne = | Bodyweight (kg) |
| (Daily feed intake (kg) x 112) |
To avoid under dosing, all incorporation rate calculations as presented above should be based on the heaviest pig in the group.
For incorporation into dry feed at the registered mill.
A manufacturer who is approved to incorporate veterinary medicinal products, or premixtures containing such products, directly at any concentration, must be responsible mixing when incorporation is less than 2kg per tonne for final feed.
To ensure adequate distribution of the product in the final feed it isrecommended to premix the product at a ratio of 1:10 with feed ingredientsbefore 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
Pigfen 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 welltolerated in pigs.
Withdrawal periods
Meat and offal: 4 days