Target species
Pigs
Indications for use, specifying the target species
Flubendazole is a broad spectrum anthelmintic, effective against mature and immature stages of the following nematodes of the gastro-intestinal tract:
Ascaris suum, (large roundworm) including migrating larvae, Hyostrongylus rubidus, (red stomach worm), Oesophagostomum dentatum (nodular worm), Trichuris suis (whipworm) and Strongyloides ransomi (threadworm) (adult).
Flubendazole is ovicidal.
Contraindications
Do not use in case 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.
∙ Underdosing, 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
i. Special precautions for use in animals
Not applicable.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental ingestion by humans should be avoided. May cause sensitisation by skin contact. May cause skin and eye irritation. Wear overalls, safety glasses and impervious gloves when mixing and handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. If the operation involves potential exposure to dust, wear either a disposable filter on a half mask respirator, conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 fitted with a filter to EN 143.
Adverse reactions (frequency and seriousness)
None known.
Use during pregnancy, lactation or lay
The product may be used in pregnant and lactating animals.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
To ensure administration of a correct dose, 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.
Individual treatment (single administration):
i. Dosage:
Add 1 g of the veterinary medicinal product for each 10 kg bodyweight onto the finished feed, as a single animal dose. (This is equivalent to 5 mg of flubendazole per one kg bodyweight). One 13 g measuring spoon treats one 130 kg sow.
ii. Treatment frequency:
Twice a year unless recommended otherwise by a veterinary surgeon. Pigs brought onto the premises should be treated on arrival and before mixing with other animals. Regular faecal examination is advocated to know which worms are present on the farm so that specific measures may be taken to prevent re-infection.
iii. Treatment of clinical worm infestations:
Treat relevant infestations at the following intervals:
Nodular worm (Oesophagostomum dentatum) - every 2 months
Large roundworm (Ascaris suum) - every 2 months
Red stomach worm (Hyostrongylus rubidus) - every month
Whipworm (Trichuris suis) - every 6 weeks.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Flubendazole has a low acute oral toxicity and is well tolerated in the target species. In situations where accidental overdose is suspected of having occurred, there is no antidote and treatment should be symptomatic.
Withdrawal period(s)
Pigs must not be slaughtered for human consumption during treatment.
Pigs may be slaughtered for human consumption only after 7 days from the last treatment.
