Krka Multiwormer 50/144/150 mg Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Praziquantel 50 mg

Pyrantel embonate 144 mg

Febantel 150 mg

Excipients:

For the full list of excipients, see section 6.1.

6.1 List of excipients

Lactose Monohydrate

Maize Starch

Povidone K-30

Sodium Lauryl Sulfate

Microcrystalline Cellulose

Colloidal Anhydrous Silica

Magnesium Stearate

Meat Flavour

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Pharmaceutical form

Tablets.

Yellow coloured, round, biconvex tablets with visible darker spots, cross-scored on one side.

The tablets can be divided into halves or quarters.

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Pharmacological properties

Pharmacotherapeutic group: Anthelmintics, Benzimidazoles and related substances

ATCVet code: QP52AC55

5.1 Pharmacodynamic properties

The product contains anthelmintics active against roundworms and tapeworms. The product contains three active substances: febantel, pyrantel embonate (pamoate) and praziquantel, a partially hydrogenated pyrazino-isoquinoline derivative used widely as an anthelmintic for both human and veterinary use. Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis and thereby allow removal from the gastro-intestinal (GI) system by peristalsis.

With the mammalian system febantel undergoes ring closure forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerization. Formation of microtubules is thereby prevented, resulting in disruption to structures vital to the normal functioning of the helminth. Glucose uptake, in particular, is affected, leading to depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2 – 3 days later.

Praziquantel is very rapidly absorbed and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in contraction and paralysis. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolisation of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

In this fixed combination product pyrantel and febantel act synergistically against nematodes (ascarids and hookworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala and Ancylostoma caninum. The spectrum of activity of praziquntel covers also cestode species in dogs, in particular all Taenia spp. and Dipylidium caninum. Praziquantel acts against adult and immature forms of these parasites.

5.2 Pharmacokinetic particulars

Perorally administered praziquantel is absorbed almost completely from the intestinal tract. After absorption, the drug is distributed to all organs. Praziquantel is metabolized into inactive forms in the liver and secreted in bile. It is excreted within 24 hours to more than 95% of the administered dosage. Only traces of non-metabolised praziquantel are excreted.

The pamoate salt of pyrantel has low aqueous solubility, an attribute that reduces absorption from the gut and allows the drug to reach and be effective against parasites in the large intestine. Because of the low systemic absorption of pyrantel pamoate, there is very little danger of adverse reactions/toxicity in the host. Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.

Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.

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Target species

Dogs (small and medium size)

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Indications

For the treatment of mixed infestations with the following roundworms and tapeworms in adult dogs and puppies:

Nematodes

Ascarids: Toxocara canis, Toxascaris leonina (late immature forms and mature forms)

Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults)

Cestodes

Tapeworms: Taenia spp., Dipylidium caninum

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Dosage

For oral administration.

It is important to follow the treatment recommendations as presented here. Do not deviate from the recommendations without the advice of your veterinary surgeon.

Dosage

The recommended dose rates are: 15 mg/kg body weight febantel, 14.4 mg/kg pyrantel and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 10 kg body weight. Tablets may be halved/quartered to allow accuracy of dosing.

Administration and Duration of Treatment

The tablet(s) can be given directly to the dog or disguised in food. No restriction of access to food is required either before or after administration of the product.

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

Puppies may be wormed with this product from 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 monthly intervals until 6 months of age. It is advisable to treat the bitch at the same time as the puppies. For the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every 2 weeks until weaning.

For adult dogs, a single dose should be used. The advice of a veterinarian should be sought regarding the need for and frequency of repeat treatment.

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Contraindications

Do not use simultaneously with piperazine compounds.

Do not use in bitches during the first two-thirds of pregnancy.

Do not use in animals with a known hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs younger than 2 weeks of age and/or weighing less than 2 kg.

Do not use simultaneously with other deworming products without veterinary advice.

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Adverse reactions

In very rare cases slight and transient digestive tract disorders such as loose faeces vomiting and /or diarrhoea may occur. In individual cases these signs can be accompanied by nonspecific signs such as lethargy, anorexia or hyperactivity

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

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Warnings

Special precautions for use in animals

Do not exceed the stated dose, especially when treating pregnant bitches.

In dogs less than 6 weeks old, tapeworm infections are highly uncommon. Treatment of animals less than 6 weeks old with a fixed combination product against cestodes and nematodes may, therefore, not be necessary.

To minimise the risk of reinfestation and new infestation, any excreta within 24 hours following treatment should be collected and properly disposed of.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In the interests of good hygiene, persons administering the tablet directly to a dog or by adding it to the dog's food, should wash their hands afterwards.

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

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Use during pregnancy, lactation or lay

Consult a veterinary surgeon before treating pregnant animals.

The tablets may be used during lactation (see Section 4.9).

Do not use in bitches during the first two-thirds of pregnancy.

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Interactions

Do not combine with piperazine as the anthelmintic effects of pyrantel and piperazine (used in many worming products for dogs) may be antagonized.

Concurrent use with other cholinergic compounds can lead to toxicity.

Simultaneous administration of compounds that inhibit the activity of acetylcholinesterase - AChE (e.g.organophosphates) may increase systemic effects of pyrantel.

Plasma concentrations of praziquantel may be decreased by concomitant administration with drugs that increase the activity of cytochrome P-450 enzymes (e.g. dexamethasone, phenobarbital).

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Overdose

Benzimidazoles possess a wide safety margin. Pyrantel is not absorbed systemically to any extent. Praziquantel also has a wide safety margin, of up to five times the recommended dose.

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Special warnings

Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to re-occur unless control of intermediate hosts such as fleas, mice etc. is undertaken.

Dogs may become infected with worms by eating insects (including fleas and lice), birds, small rodents, rabbits or raw offal from affected sheep, goats and cattle. Dogs will continue to be re-infected unless the route of infection is controlled e.g. treating a flea infestation or preventing a dog from scavenging or hunting.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

OPA/Al/PVC-Al blister

Cardboard box containing 2 or 4 tablets.

Not all pack sizes may be marketed.

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Storage

This medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Any part-used tablets should be discarded.

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Disposal of unused product

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

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Additional information

Vm 01656/5000

9 DATE OF FIRST AUTHORISATION

21 July 2021

10 DATE OF REVISION OF THE TEXT

May 2022

Approved: 18 May 2022

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Registration holder

KRKA, d.d., Novo mesto

Šmarkeška cesta 6

8501 Novo mesto

Slovenia

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