SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bob Martin Clear 3 in 1 Wormer XL 525/504/175 mg Tablets for Large Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances mg per tablet

Febantel 525.0

Pyrantel embonate 504.0

Praziquantel 175.0

Excipients

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Tablet.

Yellow oval shaped tablet scored on both sides.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

For the control of the following roundworms and tapeworms in adult dogs:

Ascarids:	Toxocara canis, Toxascaris leonina (adult and late immature forms).
Hookworms:	Uncinaria stenocephala, Ancylostoma caninum (adults)
Whipworms:	Trichuris vulpis (adults)
Tapeworms:	Echinococcus spp. Taenia spp. and Dipylidium caninum (adult and immature forms).

4.3 Contraindications

Do not use simultaneously with piperazine compoundsas piperazine may block the action of pyrantel embonate contained in Bob Martin Clear 3 in 1 Wormer XL 525/504/175 mg Tablets for Large Dogs. Other worming products may contain piperazine.

4.4 Special warnings for each target species

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.

Echinococcus multilocularisis a tapeworm of foxes, dogs and cats which is common in parts of Europe. It can also infect humans potentially causing severe liver disease which can be fatal. To prevent Echinococcus multilocularisestablishing in the UK and Ireland it is a requirement that all dogs must be treated with a product containing praziquantel before entering the country.

4.5 Special precautions for use

Do not exceed the stated dose when treating pregnant bitches.

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 tablet directly to a dog or by adding it to the dog’s food, should wash their hands afterwards.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy and lactation

Consult a veterinary surgeon before treating pregnant animals. Bob Martin Clear 3 in 1 Wormer XL 525/504/175 mg Tablets for Large Dogs may be used during lactation (see Section 4.9 below).

4.8 Interaction with other medicinal products and other forms of interaction

Do not use simultaneously with piperazine.

4.9 Amounts to be administered and administration route

Dosage

The recommended dose rates are: 15 mg/kg bodyweight febantel,

14.4 mg/kg pyrantel and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 35 kg bodyweight. It is important to follow the treatment recommendations as presented here. Do not deviate from the recommendations without the advice of your veterinary surgeon.

Dogs of 35 kg bodyweight 1 Bob Martin Clear 3 in 1 Wormer XL 525/504/175 mg Tablets for Large Dogs

Dogs of > 35 kg bodyweight 1 Bob Martin Clear 3 in 1 Wormer XL 525/504/175 mg Tablets for Large Dogs plus the appropriate quantity of Bob Martin 3 in 1 Dewormer Tablets for Dogs equivalent to 1 tablet per 10 kg bodyweight

Administration and Duration of Treatment

Oral administration: the tablet(s) 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 the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every 2 weeks until weaning.

For routine control adult dogs should be treated every 3 months. In case of suspected heavy roundworm infestation, please contact your veterinary surgeon for diagnosis and treatment recommendation

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Bob Martin Clear 3 in 1 Wormer XL 525/504/175 mg Tablets for Large Dogs is well tolerated in dogs. In safety studies doses of 5 x or greater gave rise to occasional vomiting.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

The product contains anthelmintics active against roundworms and tapeworms. The product contains three active substances:

2) Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative, and

3) Praziquantel, a partially hydrogenated pyrazino-isoquinoline derivative.

ATC VetCode:QP52AA51

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.

Praziquantel is very rapidly absorbed and distributed throughout the parasite. Both in vivo and in vitro 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.

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.

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 to 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.

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.

There is no known resistance to the active ingredients or the combination contained in Bob Martin Clear 3 in 1 Wormer XL 525/504/175 mg Tablets for Large Dogs.

5.2 Pharmacokinetic Properties

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 2-3 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize starch

Lactose monohydrate

Microcrystalline cellulose

Povidone K25

Magnesium stearate

Sodium laurilsulfate

Silica colloidal anhydrous

6.2 Incompatibilities

None known.

6.3 Shelf-life

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

6.4 Special precautions for storage

Do not store above 25ºC.

Protect from light.

Any part-used tablets should be discarded.

6.5 Nature and composition of immediate packaging

Container material:	PVC-coated aluminium foil
Container colour:	White
Container sizes:	Cartons containing 2, 10, 20, and 50 tablets Not all pack sizes may be marketed.
Contents:	Pale yellow tablets

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

7. MARKETING AUTHORISATION HOLDER

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER

Vm00010/4126

9. DATE OF FIRST AUTHORISATION

Date: 20 August 2002

10. DATE OF LAST REVISION OF THE TEXT

Date: November 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

APPROVED 20/11/14