SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

	Member State	Proposed name
	AT	Drontal Junior
	DE	Welpan für Welpen und junge Hunde
	EE	Drontal Puppy
	FI	Welpan vet
	FR	Dronstop Chiot
	ES	Drontal suspensión oral para cachorros y perros jóvenes
	IE	Drontal Oral Suspension for Puppies
	IS	Welpan vet
	LT	Drontal Puppy
	LV	Drontal Puppy
	NO	Welpan vet
	UK	Drontal Oral Suspension for Puppies

Febantel 15 mg/ml / Pyrantel 5 mg/ml

Oral Suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains

Active substances:

Febantel 15.00mg

Pyrantel 5.00mg (as pyrantel embonate 14.40mg)

Excipients:

Sodium benzoate (E211) 2.05mg

Sodium propionate (E281) 2.05mg

Ponceau 4R (E124) 0.25mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension

Pale red suspension

4. CLINICAL PARTICULARS

4.1 Target species

Dogs (puppies and young dogs up to one year of age)

4.2 Indications for use, specifying the target species

For the treatment of roundworm infections in puppies and young dogs up to one year of age caused by:

Ascarids: Toxocara canis

Toxascaris leonina

Hookworms: Ancylostoma caninum

Uncinaria stenocephala

Whipworm: Trichuris vulpis

4.3 Contraindications

Do not use simultaneously with compounds containing piperazine. See sections 4.7 and 4.8.

4.4 Special warnings

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

4.5 Special precautions for use

Special precautions for use in animals

The safety of the product has not been assessed in puppies younger than 2 weeks and weighing less than 0.600 kg.

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

Wash hands after use,

Avoid direct contact with the skin and eyes. In case of accidental spillage wash the affected area immediately with clean running water.

Other precautions

None

4.6 Adverse reactions (frequency and seriousness)

In very rare cases mild transient digestive tract signs (e.g., vomiting diarrhoea) may occur.

4.7 Use during pregnancy, lactation or lay

Do not use in pregnant and lactating bitches.

4.8 Interaction with other medicinal products and other forms of interaction

The anthelmintic effects of both pyrantel (spastic paralysis) and piperazine (neuromuscular paralysis) may be antagonised when the two drugs are used together.

4.9 Amounts to be administered and administration route

Dosage and Treatment Schedule

For a single oral adminstration 15 mg/kg bodyweight febantel and 5 mg/kg bodyweight pyrantel (as embonate) corresponding to 14.4 mg/kg pyrantel embonate, equivalent to 1 ml/kg bodyweight.

Through intrauterine and trans-mammary infection, ascarid infestation may occur in dogs at a very early age. For some animals, especially in case of severe infections, elimination of ascarids may be incomplete, and a potential risk of infections to humans cannot be excluded. Where epidemiologically appropriate, it is recommended that treatment should be started at 2 weeks of age and should be performed repeatedly at suitable intervals (for example every 2 weeks), until weaning. Otherwise treatment should be based upon confirmed infection, for example the results of faecal examinations.

Method of Administration

Oral administration. The product may be given directly to the animal or mixed with feed. No special dietary measures are necessary.

Mix the product by inversion of the container before drawing the required dose.

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

Doses of up to 5 times the therapeutic level of the product have been administered to puppies and young dogs without clinical signs of intolerance arising.

At 10 times the recommended dose the first sign of intolerance – vomiting – was evident.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Fixed combination of two anthelmintics: a tetrahydro-pyrimidine derivative, pyrantel (as the embonate) and a pro-benzimidazole, febantel.

ATCvet code QP52AF02.

5.1 Pharmacodynamic properties

In this fixed combination product, the pyrantel and febantel act synergistically against nematodes (ascarids, hookworms and whipworms) of dogs. In particular, the spectrum of activity covers Toxocara canis, Ancyclostoma caninum andTrichuris vulpis. Published data are also available to confirm that Toxascaris leonina andUncinaria stenocephala are also susceptible to this particular combination of actives.

Febantel, N-{2-[2,3-bis,(methoxycarbonyl)-guanidino]-5-(phenylthio) phenyl}-2-methoxyacetamide, is a pro-benzimidazole. 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 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.

Pyrantel, (E)-1,4,5,6-Tetrahydro-1-methyl-2-[2-(2-thienyl) vinyl] pyrimidine pamoate belongs to the tetrahydropyrimidine type. Its mode of action is to stimulate nicotinic cholinergic receptors inducing spastic paralysis and thereby allowing removal from the gastro-intestinal (GI) system by paralysis.

5.2 Pharmacokinetic particulars

Literature reports indicate after oral application of the recommended dose of 1 ml/kg bodyweight (corresponding to 14.4mg/kg pyrantel embonate and 15 mg/kg febantel) maximum serum concentrations for febantel were found between 1 and 6 hours with with a C_maxof 0.019 mg/l two hours after dosing. As febantel as a pro-drug is metabolised to fenbendazol which is further converted to oxfendazole, also these metabolites were measured. C_maxof febendazole was 0.130 mg/l after 3 hours and C_maxof oxfendazole was 0.157 mg/l at about 5 hours after application.

The C_maxof pyrantel (measured as pyrantel base) was 0.084 mg/l 2.5 hours after application.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate (E211)

Sodium propionate (E281)

Ponceau 4R (E124)

Sodium dihydrogen phosphate dihydrate

Sorbitan oleate (E494)

Povidone K25 (E1202)

Polysorbate 80 (E433)

Docusate sodium

Bentonite (E558)

Citric acid anhydrous (E330)

Xanthan gum (E415)

Propylene glycol (E1520)

Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale:	5 years
Shelf-life after first opening the immediate packaging:	12 weeks

6.4. Special precautions for storage

Do not use after expiry date.

This unopened veterinary medicinal product does not require any special storage conditions. After opening, store the product at a temperature not exceeding 25 ºC.

6.5 Nature and composition of immediate packaging

Material of the primary container:	White high density polyethylene bottle White polypropylene screw closure Colourless low density polyethylene adapter insert
Container volumes:	50 ml, 100 ml (Not all pack sizes may be marketed)
Devices supplied (if relevant)	5ml transparent polypropylene syringe with rubber plunger

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

UK	IE
Bayer plc, Animal Health Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA	Bayer Ltd, Animal Health Division, The Atrium, Blackthorn Road, Dublin 18. Ireland

8. MARKETING AUTHORISATION NUMBER

UK	IE
Vm 00010/4102	VPA 10021/53/1

9. DATE OF FIRST AUTHORISATION

17 April 1998

10. DATE OF REVISION OF THE TEXT

July 2013

APPROVED 3/07/13