Bayer Praziquantel 50 Mg Tablets
Issued: September 2014
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Bayer Praziquantel 50 mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Praziquantel 50 mg per tablet
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Target species
Cats and dogs.
4.2 Indications for use, specifying the target species
For the treatment of adult tapeworms of cats and dogs. The tablets are effective against both immature and mature forms of adult tapeworms in both cats and dogs.
The product is a highly effective treatment against all the common species of tapeworm infecting cats and dogs in the United Kingdom including Echinococcus granulosus, Taenia ovis, Taenia pisiformis, Taenia multiceps, Taenia hydatigena, Taenia taeniaeformis, andDipylidium caninum. The product is also effective against Echinococcus multilocularis (see 4.4)
Do not administer to dogs weighing less than 2.5 kg.
Do not administer to unweaned kittens and puppies as such animals are rarely infected with tapeworms.
4.4 Special warnings for each target species
Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum. To avoid reinfection with this parasite, flea control of the animal and its housing should be carried out at the same time. Unless flea control is complete an infected flea population may survive: i.e. re-treatment of the animal may be necessary.
As a precautionary measure to prevent the establishment of Echinococcus multilocularis in the UK, it is recommended that all cats and dogs entering the country be treated with praziquantel.
4.5 Special precautions for use
Special precautions for use in animals
Any part-used tablets should be discarded.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In the interests of good hygiene, persons administering the tablets directly to an animal or adding them to the animal’s food should wash their hands afterwards.
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
The product may be administered to pregnant females. It is safe to the female herself, to the unborn foetus and to the new born young,
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
The recommended dose rate is 5 mg/kg body weight. This corresponds to 1 tablet per 10 kg body weight.
2.5 – 5.0 kg
6.0– 10.0 kg
11.0 – 20.0 kg
21.0 – 30.0 kg
Over 30 kg
Administration and Duration of Treatment
For oral administration.
The tablets are administered by opening the animal’s mouth and pushing the tablet over the back of the tongue so that it cannot be rejected. Alternatively, a tablet can be wrapped in a piece of meat or butter and offered to the animal or crushed and mixed with the food.
A single dose is all that is required. However, for dogs in rural areas and for packs of hounds, this dose should be repeated every four weeks to ensure that newly acquired tapeworms are destroyed before reaching maturity. Dosing must be associated with strict control of the dog’s diet to ensure that uncooked offal is not eaten.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Pyrazino-isoquinoline derivative, with anthelmintic activity.
ATCvet code: QP52AA01
5.1 Pharmacodynamic properties
The spectrum of action of praziquantel covers all the important species of cestodes in cats and dogs. It specifically includes all Taeniaspecies occurring in cats and dogs, Multiceps multiceps, Joyeuxiella pasquali, Dipylidium caninum, Mesocestoidesspecies, Echinococcus multilocularis and E.granulosus.Praziquantel is effective against all stages of development of these parasites occurring in the intestines of cats and dogs.
Praziquantel impairs the normal tegument function of the parasite, making it permeable to excessive glucose loss and thereby more easily attacked by proteolytic enzymes. Because of this, whole tapeworms including the scolex are very rarely passed in the faeces following administration of the drug. Disintegrated and partially digested fragments may occasionally be seen in the faeces.
5.2 Pharmacokinetic particulars
Praziquantel is rapidly absorbed by the animal and metabolised by the liver. It is excreted, entirely as metabolites, in the urine and faeces.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium lauryl sulphate
Silica colloidal anhydrous
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.
6.4. Special precautions for storage
Do not store above 25 C.
Store in a dry place.
6.5 Nature and composition of immediate packaging
Aluminium foil blister or polyethylene coated aluminium blister; silver or white coloured.
Cartons containing 100 tablets (10 x 10 tablet blisters).
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Animal Health Division
8. MARKETING AUTHORISATION NUMBER
9. DATE OF FIRST AUTHORISATION
25 September 2014
10. DATE OF REVISION OF THE TEXT
Page 4 of 4