FENBENDAZOL 10% PREMIX

Medicated premix

FENBENDAZOL 10% PREMIX
100 mg/g, fenbendazol, premix for medicated feed for pigs, cattle and sheep.

1. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
FENBADEM 10% PREMIX is a white powder that contains per 1 gram:
Fenbendazole …………………………………..… 100 mg
Excipient (corn starch) up to.………………………. 1 g

2. INDICATIONS
In pigs: the product is recommended for the prevention and treatment of Trichinella spiralis (high efficacy) infestation and for other nematode infestations: Ascaris suum, Oesophagostomum dentatum, Trichuris suis, Stephanurus dentatum and Metastrongylus elongatus and some cestodes Diphilobothrium spp.
In cattle and sheep: the product is used for the prevention and treatment of several nematodes infestations: Haemonchus spp., Ostertagia spp., Trichostrongylus spp., Marshallagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp, Chabertia spp., Oesophagostomum spp., Strongyloides spp. and cestodes: Moniedaya spp., Avitelina spp., Thisaniedaya spp., Stilesia spp.

3. CONTRAINDICATIONS
None.

4. ADVERSE REACTIONS
None.
5. TARGET SPECIES
Pigs, cattle and sheep.

6. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The product is administered via feed in the following dosages:
Pigs: for the treatment of trichinelosis the product is administered in dosage of 75 mg FENBADEM 10% premix/kg body weight, for 14 consecutive days. For the treatment of other round worm infestation the product is administered in dosage of 75 mg FENBADEM 10% premix/kg body weight, for 3 consecutive days, repeating the treatment once more after 14-21 days. For the treatment of Stephanurus dentatum infestation and also for cestodes infestation, the product is administered in dosage of 100 mg FENBADEM 10% premix /kg body weight, for 3 consecutive days, repeating the treatment once more after 14-21 days.
Cattle and sheep: For treatment of round worm infestation, the product is administered as brewage or via feed in dosage of 75 mg FENBADEM 10% premix/kg body weight, for 3 consecutive days. For treatment of cestodes infestations, the product is administered in dosage of 100 mg FENBADEM 10% premix/kg body weight, for 3 days, repeating the treatment once more after 14-21 days.

Based on the recommended doses and the number and weight of the animals to be treated, the exact daily amount of FENBENDAZOL 10% PREMIX should be calculated according to the following formula:

mg FENBENDAZOL 10% PREMIX / kg body weight/day x mean body weight of animals to be treated

mg FENBENDAZOL 10% PREMIX / kg feed

Mean daily feed consumption (kg) / animal

=

The uptake of medicated feed is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in feed may have to be adjusted

7. ADVICE ON CORRECT ADMINISTRATION
During treatment, the animals should eat only medicated feed. To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing. The use of suitable calibrating weighing equipment is recommended if part packs are used. The product should be well mixed with the feed to be homogenous.

8. WITHDRAWAL PERIOD
Edible tissues: 28 days after cessation of oral medication.
For milk: 7 days after cessation of oral medication.

9. SPECIAL PRECAUTIONS FOR STORAGE
Keep away from reach and sight of children!
Store in original packaging at temperatures below 25oC, protected from moisture and direct sunlight.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after dilution in drinking water, according to directions: 24 hours.
Shelf life after first opening of the package: 7 days.
Shelf life after incorporation into meal: 7 days
Do not use after expiry date which is stated on the label.