White, bi-convex, oval film coated tablet, scored on one side. The tablet can be divided into halves. The tablet contains Pyrantel embonate 230mg (equivalent to 80mg Pyrantel) and Praziquantel 20mg.

For the treatment of mixed infestations with roundworms and tapeworms in cats, caused by:

- adult stages of ascarids: Toxocara cati (syn. mystax)

- adult stages of hookworms: Ancylostoma tubaeforme, Ancylostoma braziliense

- tapeworms: Echinococcus multilocularis, Dipylidium caninum, Hydatigera (Taenia) taeniaeformis, Mesocestoides spp., Joyeuxiella pasqualei.

FOR ORAL ADMINISTRATION

Dosage:

5 mg praziquantel and 20 mg pyrantel base (57.5 mg pyrantel embonate) per kg of body weight. This corresponds to 1 tablet per 4 kg of body weight. Kittens weighing less than 1 kg should not be treated with the product, because correct dosing of such cats may not be feasible.

Administration:

The tablets are to be given directly into the mouth but can be administered in a small amount of food, if necessary.

Duration of treatment:

Single treatment. In ascarid infestation, especially in kittens, complete elimination cannot be expected, so a risk of infection for humans can persist. Repeat treatments should therefore be carried out with a suitable roundworm product at 14 day intervals until 2-3 weeks after weaning.

The safety of the veterinary medicinal product has not been established during pregnancy. The product should not be used during pregnancy but may be used during lactation.

Do not use simultaneously with piperazine compounds, because the specific activities of piperazine (neuromuscular paralysis of the parasites) can inhibit the efficacy of pyrantel (spastic paralysis of the parasites).

None.

In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.

In the interest of good hygiene, persons administering the tablets directly to the cat or by adding them to the cat’s food, should wash their hands afterwards.

Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

Mild and transient digestive tract disorders such as hypersalivation and/or vomiting and mild and transient neurological disorders such as ataxia may occur in extremely rare cases.

Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.

Environmental Safety
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Store unused parts of the halved tablets below 25°C. Each time an unused part-tablet is stored until next use, it should be returned to the open blister pocket and kept in a safe place out of the sight and reach of children.

Shelf-life of unopened package: 3 years.

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Shelf life of halved tablets after first opening the immediate packaging: 1 month

Blister packs consisting of cold formed OPA/Aluminium/PVC foil and aluminium foil containing 2 or 10 tablets.

2 x 1, 4 x 1, 10 x 1, 30 x 1, 50 x 1 or 100 x 1 tablet in perforated unit dose blisters, in a box.

Not all pack sizes may be marketed.

KRKA, d.d., Novo mesto

Šmarješka cesta 6

8501 Novo mesto

Slovenia

Pharmacotherapeutic group: Anthelmintics, quinoline derivatives and related substances, praziquantel, combinations.

ATCvet code: QP52AA51

Symptoms of overdoses do not occur less than 5 times the recommended dose. The first expected sign of intoxication is vomiting.

The product is a roundworm and tapeworm anthelmintic containing as active constituents the pyrazinoisoquinolinone derivative praziquantel and the tetrahydropyrimidine derivative pyrantel (as embonate salt).

In this fixed combination praziquantel serves as a tapeworm agent whose action spectrum covers cestode species in cats, in particular Hydatigera (Taenia) taeniaeformis, Joyeuxiella pasqualei., Dipylidium caninum, Mesocestoides spp. and Echinococcus multilocularis. Praziquantel acts against all stages of these parasites occurring in the cat intestine.

Pyrantel is the roundworm-specific component and has a good activity against nematodes occurring in cats, in particular Toxocara cati (syn. mystax), and Ancylostoma tubaeformae and Ancylostoma braziliense. Pyrantel acts as a cholinergic agonist similarly to nicotine, and causes spastic paralysis of the nematodes by a depolarising neuromuscular blockade.

Praziquantel is absorbed very rapidly through the parasite's surface and is distributed evenly inside the parasite. Both in vitro and in vivo severe damage to the parasite integument sets in very quickly, resulting in contraction and paralysis of the parasites. The basis for the rapid onset of action is above all the praziquantel-induced change in the permeability of the parasite membrane to Ca++, which leads to a dysregulation of the parasite.

Praziquantel is rapidly absorbed following oral administration. Maximum serum levels are achieved within 2 hours. Praziquantel is widely distributed and is rapidly metabolised in the liver. In addition to other metabolites, the main metabolite occurring in each case is the 4-hydroxycyclohexyl derivative of praziquantel. Praziquantel is completely eliminated within 48 hours in the form of its metabolites - between 40 and 71 % in the urine and, in bile, between 13 and 30 % in the faeces.

The embonate salt of pyrantel is poorly absorbed from the gastrointestinal tract.

Vm 01656/4116