Drontal Puppy
The Drontal dose 1ml per kg bodyweight, Drontal puppy liquid is very convenient in use as the wormer dosage is just given as a single dose per puppy every two weeks from two weeks of age, until twelve weeks of age. THEREAFTER DRONTAL PLUS SHOULD BE USED EVERY THREE MONTHS for regular dog worming. PLEASE NOTE:- After opening - Drontal puppy liquid should be discarded after 10 weeks. Contains - Pyrantel and febantel The safety of the product has not been assessed in puppies younger than 2 weeks and weighing less than 0.600 kg.
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Oral Suspension for Puppies
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances:
Febantel
15.0 mg
Pyrantel
5.0 mg (as pyrantel embonate 14.4mg)
Excipients:
Sodium benzoate (E211) 2.05 mg
Sodium propionate (E281) 2.05 mg
Ponceau 4R (E124) 0.25 mg
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 for each target species
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 or IMMUNOLOGICAL PROPERTIES
Fixed combination of two anthelmintics: a tetrahydro-pyrimidine derivative, pyrantel (as the embonate) and a probenzimidazole, 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 and Trichuris vulpis. Published data are also available to confirm that Toxascaris leonina and Uncinaria 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 probenzimidazole. 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 properties
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 Cmax of 0.019 mg/l two hours after dosing. As febantel as a pro-drug is metabolised to fenbendazole which is further converted to oxfendazole, also these metabolites were measured. Cmax of febendazole was 0.130 mg/l after 3 hours and Cmax of oxfendazole was 0.157 mg/l at about 5 hours after application.
The Cmax of 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 25ºC.
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:
50ml, 100ml.
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 products or waste materials
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
Bayer Ltd.
Animal Health Division
The Atrium
Blackthorn Road
Dublin 18
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
VPA: 10021/053/001
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23 May 2008
Date of last authorisation: 22 May 2013
10 DATE OF REVISION OF THE TEXT
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