Multivermyx Cat 80/20 mg tablet

. Qualitative and quantitative composition

One tablet contains :

Active substance(s):
Pyrantel ................................. 80,0 mg
(as embonate)
(i.e. 230 mg pyrantel embonate)
Praziquantel............................. 20.0 mg

Pharmaceutical form

Tablet.
Yellow tablet with a score bar.
The tablet can be divided into half tablets.

Clinical information

1. Target species
Cats.

2. Indications for use, specifying target species
In cats:
- Curative treatment of mixed infestations of gastrointestinal parasites susceptible to praziquantel and pyrantel:
- Adult nematodes:
Toxocara cati
Ancylostoma tubaeforme
Ancylostoma braziliense

- cestodes:
Taenia taeniaeformis

3. Contraindications
Do not use in case of known hypersensitivity to pyrantel, praziquantel or any of the excipients.
Do not use concomitantly with cholinergic compounds (e.g. piperazine).
Do not use in cats under 8 weeks of age or weighing less than 1 kg.

See also "Use during gestation, lactation or egg-laying" and "Drug and other interactions".

4. Target Species Specific Warnings
Taenia taeniaeformis infestation may recur unless control of intermediate hosts such as rodents is undertaken.
Because they increase the risk of resistance development and may ultimately lead to ineffective treatment, the following practices should be avoided:
- too frequent and repeated use of anthelmintics of the same class over a prolonged period of time.
- underdosing due to underestimation of the animal's weight or improper administration of the product.

5. Special precautions for use
i) Special precautions for use in animals
Not applicable.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
In case of accidental ingestion by a child, seek medical advice immediately and show the package leaflet or label.

(iii) Other precautions
None.

6. Adverse reactions (frequency and severity)
Treated animals may experience transient diarrhoea (very common), related to the elimination of parasites.
In very rare cases, other mild and transient digestive disorders such as hypersalivation and/or vomiting may occur.

The frequency of adverse reactions is defined as:
- very common (adverse reactions in more than 1 in 10 treated animals)
- common (1 to 10 in 100 treated animals)
- uncommon (1 to 10 in 1,000 treated animals)
- rare (1 to 10 in 10,000 treated animals)
- very rare (less than 1 in 10,000 treated animals, including isolated cases).

7. Use during pregnancy, lactation or oviposition
Praziquantel and pyrantel have not been shown to affect reproductive parameters in cats. No embryotoxic, fetotoxic or teratogenic effects have been demonstrated in laboratory animals (rats, mice) for pyrantel and praziquantel, and in cats for praziquantel.
The safety of the veterinary medicinal product has not been investigated in pregnant or lactating cats.
Not recommended for use during gestation.
May be used during lactation

8. Drug and other interactions
Do not use concomitantly with other cholinergic compounds (e.g. piperazine) as the specific activities of these cholinergic compounds (neuromuscular paralysis of parasites) may inhibit the effectiveness of pyrantel (spastic paralysis of parasites).

9. Dosage and route of administration
Oral.
5 mg praziquantel and 20 mg pyrantel (57.5 mg as pyrantel embonate) per kg body weight, i.e. 1 tablet per 4 kg body weight in a single dose.
To ensure correct dosing, the body weight should be determined as accurately as possible.
The dosage is presented in the following table:

Tablets may be given directly into the mouth or mixed with food.
No dietary measures are required.
In cases of infestation with Toxocara cati, particularly in kittens, complete elimination cannot be envisaged and the risk of transmission to humans may persist. Additional treatments should be carried out at intervals of 14 days until 2-3 weeks after weaning, using a product effective against Toxocara cati.

10. Overdose (symptoms, emergency procedures, antidotes), if necessary
At three times the recommended dose of the praziquantel/pyrantel combination, vomiting and diarrhoea have been observed.

11.Waitingtime
Not applicable.

Pharmacological properties

Pharmacotherapeutic group: anthelmintic product

Pharmacodynamic properties
The product is an anthelmintic containing praziquantel, a pyrazinoisoquinoline derivative, and pyrantel, a tetrahydropyrimidine derivative (as embonate), active against nematodes and cestodes.

Praziquantel acts on cestodes; its spectrum of action includes Taenia taeniaeformis. It acts on all stages of development of these parasites of the cat's intestine. The parasites absorb praziquantel very rapidly from their surface. Praziquantel is homogeneously distributed in the parasite. In vitro and in vivo, significant lesions are rapidly observed in the parasite integument, leading to contraction and paralysis of the parasites. This rapid onset of action is explained by the fact that praziquantel modifies the permeability of the parasite membrane to calcium ions, which leads to a deregulation of parasite metabolism.

No resistance to praziquantel has been reported in cats. The mechanism of resistance has been studied in mice. In parasites less sensitive to praziquantel, there was less inhibition of liver enzymes, and thus more metabolism of praziquantel, resulting in lower exposure for the parasite.

Pyrantel acts specifically on nematodes, particularly Toxocara cati, Ancylostoma tubaeforme and Ancylostoma braziliense. It exerts a nicotinic cholinergic agonist effect and causes spastic paralysis of the nematodes through depolarizing neuromuscular blockade.

No resistance to pyrantel has been reported in cats. The mechanisms of resistance are not clearly identified, but appear to involve the different cholinergic receptor subtypes, to which pyrantel binds, in the parasite.

Pharmacokinetics
Praziquantel is very rapidly and almost completely absorbed in the stomach and small intestine after oral administration. Peak plasma concentrations are usually reached within 0.3 to 2 hours. Praziquantel is very rapidly distributed to all organs. The half-lives of C14 praziquantel and its metabolites range from 2 to 3 hours. Praziquantel is rapidly metabolized in the liver. Of all the metabolites, the major one is the 4-hydroxycyclohexyl derivative of praziquantel. Praziquantel is completely eliminated within 48 hours as metabolites, between 40 and 71% in the urine and, via bile, between 13 and 30% in the feces.

Pyrantel as embonate is very poorly absorbed from the gastrointestinal tract.

Pharmaceutical information

1. List of excipients
Microcrystalline cellulose
Pregelatinised starch
Pork liver flavour
Brewer's yeast solids
Magnesium stearate
Povidone K30

2. Major Incompatibilities
None known.

3. Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

4. Special storage precautions
No special storage precautions regarding temperature.
Do not keep the half-tablets after opening.

5. Nature and composition of the immediate packaging
PVC/aluminium blister pack

6. Special precautions for disposal of unused veterinary medicinal products or waste products derived from the use of these medicinal products
Empty packagings and any leftover product must be disposed of in accordance with current practices governed by waste regulations.