Package leaflet for
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Prodivet pharmaceuticals sa/nv
Manufacturer responsible for the batch release:
LABORATORIA WOLFS NV
B – 2070 ZWIJNDRECHT
NAME OF THE VETERINARY MEDICINAL PRODUCT
Praziquantel 50,0 mg - Fenbendazole 500,0 mg
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Active substances: Praziquantel 50,0 mg - Fenbendazole 500,0 mg
Excipients: Carmellosum natricum conexum - Natrii laurilsulfas - Polyvidonum - Magnesii stearas q.s. pro tabletta compr. una.
Round cross-scored tablets bi-convex, white.
Treatment of mixed parasitic infections due to adult nematodes (round worms) and cestodes (tapeworms) in all breeds of dogs and cats.
In the dog:
Nematodes: Ancylostoma caninum, Toxocara canis, Toxascaris leonina, Trichuris vulpis, Uncinaria stenocephala
Cestodes: Dipylidium caninum, Echinococcus granulosus, Taenia spp, Echinococcus multilocularis, Mesocestoïdes spp.
In the cat:
Nematodes: Ancylostoma tubaeforme, Toxascaris leonida, Toxacara cati
Cestode: Dipylidium caninum, Echinococcus multilocularis, Taenia taeniaformis
Slight vomiting and diarrhea can occur occasionally at high dosages, especially in cats.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Dogs and cats
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
The recommended dosage is 5 mg Praziquantel and 50 mg Fenbendazole per kg body weight, which corresponds to 1 tablet per 10 kg body weight. The administration should be repeated the day after.
In case of infestation by Ancylostoma caninum, Uncinaria stenocephala, Trichuris vulpis, Echinococcus granulosus, administer one tablet per 10 kg body weight during 3 consecutive days. The dosage for cats dependent of their weight is generally ½ tablet per cat.
ADVICE ON CORRECT ADMINISTRATION
The administration of the tablets is performed directly, with or without food. No dietetic measure or fasting is necessary.
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 package
Particular warnings for use in animal
The safety of the veterinary medicinal product has not been established during pregnancy.
The use is not recommended in case of gravidity.
The treatment of puppies en kittens should start in the third week of age, after a diagnostic of mixed infection.
Interaction with other medicinal products and other forms of interaction
Do not administer with other anthelmintics
Overdose (symptoms, emergency measures, antidotes)
After an overdose of 5 times the recommended dose, vomiting and diarrhea can occur.
Special precautions to be taken by the person administering the veterinary medicinal product to the animals
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIAL, IF ANY
Medicines should not be disposed of via wastewater or household waste
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Oral Tablets for veterinary use, packs of 2, 6, 10, 20, 50, 100 tablets under blister. 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.
MARKETING AUTHORIZATION HOLDER:
PRODIVET Pharmaceuticals S.A./N.V.
B - 4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20