STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 g of white to brownish white suspension contains 100 mg of flubendazole with 2 mg of methyl parahydroxybenzoate (E218), 5 mg of sodium benzoate (E211) and 0,1 mg of disodium edetate.
INDICATION(S)
In hens/chickens:
- Treatment of helminthiasis caused by Ascaridia galli (adult stages), Heterak is gallinarum (adult
stages), Capillaria spp. (adult stages).
In pigs:
- Treatment of helminthiasis caused by Ascaris suum (adult and intestinal larval stages) in piglets, pigs for fattening, pregnant and lactating sows.
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
No undesirable effects have been demonstrated with flubendazole after administration of the therapeutic dose in pigs or in chickens.
If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
TARGET SPECIES
Pigs (piglets, pigs for fattening, pregnant and lactating sows) and chickens (layer hens, chickens for reproduction, pullets, broilers).
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use. Hens/chickens:
1.43 mg flubendazole (= 14.3 mg product) per kg body weight daily during 7 days i.e. 1 g of the product per 70 kg body weight daily for 7 days.
Pigs:
a) Treatment of helminthiasis caused by Ascaris suum (adult stages and intestinal larval stages):
1 mg flubendazole (= 10 mg product) per kg body weight daily during 5 days, i.e. 1 g of the product per 100 kg body weight daily for 5 days;
b) Treatment of helminthiasis caused by Ascaris suum (adult stages):
2.5 mg flubendazole (= 25 mg product) per kg body weight daily during 2 days, i.e. 2.5 g of the product per 100 kg body weight daily for 2 days.
Pigs should be grouped according to their bodyweight and dosed accordingly, in order to prevent under or overdosing.
Calculate the dosage accurately with the following formula:
…mg [product ] X Average bw (kg) of the
per kg bw/day treated animals = .... mg [product]
average quantity of drinking water (litre/animal) consumed per litre drinking water
in 4 h
per kg bw/day treated animals = .... mg [product]
average quantity of drinking water (litre/animal) consumed per litre drinking water
in 4 h
This will result in a concentration of flubendazole between 20 and 200 mg per litre.
ADVICE ON CORRECT ADMINISTRATION
Administration in drinking water
1) The required quantity of the product is in function of the estimated body weight of the total group animals (see table below for guidance).
Hens/chickens, 7 days of treatment
Total weight of chickens |
Amount of medication to be used (g/ day) |
Total amount of medication used (g/ 7 days) |
1400 kg 7000 kg 35000 kg |
20 g 100 g 500 g |
7 x 20 g 7 x 100 g 7 x 500 g |
Pigs, 5 days of treatment
Total weight of pigs |
Amount of medication to be used (g/ day) |
Total amount of medication used (g/ 5 days) |
2000 kg 10000 kg 50000 kg |
20 g 100 g 500 g |
5 x 20 g 5 x 100 g 5 x 500 g |
Pigs, 2 days of treatment
Total weight of pigs |
Amount of medication to be used (g/ day) |
Total amount of medication used (g/ 2 days) |
2000 kg 4000 kg 40000 kg |
50 g 100 g 1000 g |
2 x 50 g 2 x 100 g 2 x 1000 g |
2) Each day a predilution is prepared containing the daily required dose of the product admixed in 10 to 100 times its weight in water depending on the distribution system. For example: for 500 g of the product, add 5 litres to 50 litres of water.
3) Squeeze the sachet gently before use and then empty the contents into the predilution recipient.
4) If less than entire sachet is required, the required dose should be measured by suitably calibrated weighing equipment.
5) Stir the predilution vigorously with a manual mixer (whisk) for 2 minutes to obtain a white milky homogenous mixture.
6) This predilution must be distributed via the general water supply system:
Tanks: add the predilution to the quantity of water usually consumed by the animals over a period of up to 4 hours.
Dosing pumps: adjust the flow rate of the pump to distribute the predilution over a period of up to 4 hours.
In order to ensure administration of the correct dose, a substantial water flow must be present in the drinking water system. Administration of the product over a period of up to 4 hours on each treatment day, at times when water consumption is likely to be highest, prevents precipitation of flubendazole in the water delivery system and allows washing out of the drinking water system within a 24 hour period after the period of drug administration is finished.
7) Prior to and after the period of treatment make sure the water distribution system is cleaned.
8) Make sure that all animals in the group receive enough drinking water with the product. Withhold drinking water for 2 hours before treatment to stimulate thirst.
9) The corresponding dose must always be distributed when the water consumption of the animals is highest.
WITHDRAWAL PERIOD
Meat and offal: chickens: 2 days pigs:
- dose 1 mg/kg body weight for 5 days: 3 days
- dose 2.5 mg/kg body weight for 2 days: 4 days
Eggs: zero days
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the packaging after {EXP}.
Shelf life after dilution according to directions: 24 hours.
SPECIAL WARNING(S)
Special warnings for each target species
In chickens, optimal results can only be achieved if strict rules of hygiene are respected in the
maintenance of the cages. In both 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 in animals
Development disorders of the feathers cannot be fully excluded after the administration of
flubendazole.
Use during pregnancy, lactation or lay
Laboratory studies in rabbits and rats have not produced any evidence of embryotoxicity,
teratogenicity at therapeutic doses. High dosages gave equivocal results. In laboratory studies in rats, there were no effects on pups during lactation.
The safety of the product has been demonstrated in laying hens, pregnant and lactating sows. The
product can be administered to these animals.
Interaction and incompatibilities
None known.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Flubendazole has a low acute oral toxicity.
In hens, no undesirable effects have been observed after administration of up to 15 mg/kg b.w./day flubendazole.
In porcine, no adverse effects have been observed after administration of up to 50 mg/kg b.w./day flubendazole.
In situation when accidental overdose is suspected of having occurred, there is no antidote and treatment should be symptomatic.
User warnings
Direct contact with product should be avoided. Wear protective gloves while using the product. Wash
hands after use.
People with known hypersensitivity to flubendazole should avoid contact with the veterinary medicinal product. In the event of eye contact, rinse thoroughly with water. In case of appearance and persistence of conjunctival redness, seek medical advice and show the package leaflet to the physician.
Box containing 2 sachets (sachet PE/PET/aluminium/PET) of 20 g suspension for use in drinking water.
Box containing 24 sachets (sachet PE/PET/aluminium/PET) of 20 g suspension for use in drinking water.
Box containing 2 sachets (sachet PE/PET/aluminium/PET) of 50 g suspension for use in drinking
water.
Box containing 24 sachets (sachet PE/PET/aluminium/PET) of 50 g suspension for use in drinking water.
Box containing 1 sachet (sachet PE/PET/aluminium/PET) of 100 g suspension for use in drinking water.
Box containing 5 sachets (sachet PE/PET/aluminium/PET) of 100 g suspension for use in drinking water.
Box containing 25 sachets (sachet PE/PET/aluminium/PET) of 100 g suspension for use in drinking water.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.