VetUK XL Flavoured Dog Wormer Tablets 175 mg Pyrantel, 175 mg Praziquantel, 525 mg Febantel

Composition

Each tablet contains:

Active substances:

Praziquantel 175 mg

Pyrantel 175 mg (equivalent to 504 mg pyrantel embonate)

Febantel 525 mg

Excipients:

For the full list of excipients, see section 6.1.

6.1 List of excipients

Lactose monohydrate,

Microcrystalline cellulose,

Magnesium stearate,

Colloidal anhydrous silica,

Croscarmellose sodium,

Sodium laurilsulfate

Pork flavour

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Pharmaceutical form

Tablet

A yellow coloured oblong tablet with a breakline on both sides.

The tablets can be divided into halves.

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Pharmacological properties

Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.

ATC vet code: QP52AA51

5.1 Pharmacodynamic properties

This product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The product contains three active substances, as follows:

1. Febantel, a probenzimidazole

2. Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative

3. Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative

In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.

This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.

The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against all adult and immature forms of these parasites.

Praziquantel is very rapidly absorbed through the parasite’s surface 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 the contraction and paralysis of the parasites. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis.

Within 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 polymerisation. Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. Glucose uptake in particular is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2 – 3 days later.

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.

Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.

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. 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.

Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.

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Target species

Dogs.

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Indications

For the treatment of mixed infections with the following gastrointestinal roundworms and tapeworms in adult dogs:

Roundworms: Toxocara canis, Toxascaris leonina (adult and late immature forms).

Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).

Whipworms: Trichuris vulpis (adults).

Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).

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Dosage

Dosage:

The recommended dose rates are: 15mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel. This is equivalent to 1 VetUK XL Flavoured Dog Wormer tablets per 35 kg body weight.

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

Administration and Duration of Treatment

For oral administration only.

The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.

For routine treatment a single dose is recommended.

- For routine control adult dogs should be treated once every 3 months.

- For the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every 2 weeks until weaning.

In case of suspected heavy roundworm infestation, please contact your veterinary surgeon for diagnosis and treatment recommendations.

If there is a risk for re-infestation (see section 4.4), the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.

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Contraindications

Do not use simultaneously with piperazine compounds.

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

Do not exceed the stated dose.

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Adverse reactions

Slight and transient digestive tract disorders such as vomiting and/or diarrhoea may occur in very rare spontaneous reports. Nonspecific signs such as lethargy, anorexia or hyperactivity can accompany these signs in individual cases.

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

- Very common (more than 1 in 10 animals treated displaying adverse reaction(s))

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

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

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

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

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Warnings

Special precautions for use in animals

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

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

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

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

Other precautions

Echinococcosis represents a hazard for humans and is a notifiable disease according to the World Organisation for Animal Health (OIE). In the UK, suspected or confirmed Echinococcosis must be reported to the Animal and Plant Health Agency. Specific guidelines on Echinococcosis treatment, case follow-up, and any safeguards for people should be obtained from the relevant competent authority.

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Use during pregnancy, lactation or lay

Consult a veterinary surgeon before treating pregnant animals.

Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats. No studies have been performed in dogs during early pregnancy. Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian. It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy. Especially when treating pregnant bitches, do not exceed the stated dose (see section 4.3). The product may be used in lactating bitches from two weeks after giving birth (see section 4.9).

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Interactions

Do not use simultaneously with piperazine compounds (see section 4.3) as the anthelmintic effects of pyrantel and piperazine may be antagonized.

Concurrent use with other cholinergic compounds can lead to toxicity.

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Overdose

The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs. In safety studies, a single dose of 5 times the recommended doseor greater gave rise to occasional vomiting.

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Special warnings

Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken. Dogs should also be prevented from scavenging or hunting as part of measures to prevent tapeworm reinfestation.

Development of parasite resistance to anthelmintics of a certain class can occur 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

The product is presented in:

Blister packs made up of PVC/PE/PCTFE with 20µm hard tempered aluminium foil with 2 or 4 tablets per blister.

Blisters are packed into cartons containing either 2 or 4 tablets.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special temperature storage conditions.

Each time an unused half tablet is stored, it should be returned to the open blister space and inserted back into the outer carton.

Keep the blister in the outer carton.

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Shelf life

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

Unused half tablet must be used within 14 days.

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Disposal of unused product

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

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Additional information

Vm 40162/4020

9 DATE OF FIRST AUTHORISATION

04 March 2016

10 DATE OF REVISION OF THE TEXT

April 2021

Approved: 31/03/21

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Registration holder

C&H Generics Ltd

c/o Michael McEvoy and Co,

Seville House

New Dock Street

Galway

Ireland

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