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Date: Wednesday, August 5, 2020 7:00

Description: vet004
Release 2.180
Drontal Plus Flavour Bone Shaped Tablets
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for dogs, Tapeworm products
Active ingredient: Febantel, Praziquantel, Pyrantel Embonate
Product:Drontal® Plus Flavour Bone Shaped Tablets
Product index: Drontal Plus Flavour Bone Shaped Tablets
Presentation
Drontal Plus Flavour Bone Shaped Tablets are pale brown to brown flavoured bone shaped tablets scored on both sides for oral administration to dogs, containing 50 mg praziquantel, 144 mg pyrantel embonate and 150 mg febantel as active constituents and 116.5 mg Artificial beef flavour irradiated.
Uses
For the control of the following roundworms and tapeworms in dogs and puppies:
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).
Dosage and administration
For oral administration only.
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
Puppies and Small Dogs:
3-5 kg body weight = ½ tablet
6-10 kg body weight = 1 tablet
Medium Dogs:
11-15 kg body weight = 1 ½ tablets
16-20 kg body weight = 2 tablets
21-25 kg body weight = 2 ½ tablets
26-30 kg body weight = 3 tablets
Large Dogs:
31-35 kg body weight = 3 ½ tablets
36-40 kg body weight = 4 tablets
Administration and Duration of Treatment
Oral administration, the tablet(s) can be given directly to the dog or disguised in food. Access to normal diet does not need to be limited before or after treatment.
Puppies should be treated at 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 month intervals. It is advisable to treat the bitch at the same time as the puppies. Not for use in dogs weighing less than 3 kg.
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 the event of a heavy roundworm infection, a repeat dose should be given after 14 days.
Use During Pregnancy and Lactation
Consult a veterinary surgeon before treating pregnant animals for roundworms.
The product may be used during lactation.
Do not exceed the stated dosage when treating pregnant bitches.
Contra-indications, warnings, etc
Do not use simultaneously with piperazine compounds
Do not exceed the stated dosage when treating pregnant bitches.
Any part-used tablets should be discarded.
In very rare cases slight and transient digestive tract disorders such as vomiting and/or diarrhoea may occur. In individual cases these signs can be accompanied by nonspecific signs such as lethargy, anorexia or hyperactivity.
Benzimidazoles possess a wide safety margin. Pyrantel is not absorbed systemically to any extent. Praziquantel has a wide safety margin of up to five times the normal dose
User safety
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.
Environmental safety
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Pharmaceutical precautions
Do not store above 25ºC.
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years
Legal category
Legal category: NFA-VPS
Packaging quantities
Container material : Polypropylene-coated aluminium foil
Container colour : White.
Container sizes : Cartons containing 2, 6, 24 or 108 tablets.
Further information
The product contains anthelmintics active against roundworms and tapeworms. The product contains three active substances:
1) Febantel, 2) Pyrantel embonate (pamoate) and 3) Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative used widely as an anthelmintic for both human and veterinary use. ATC Vet Code: QP52AC55
In this fixed combination product pyrantel and febantel act synergistically 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.
The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular all Taenia spp, Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against adult and immature forms of these parasites.
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 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 a 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 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.
Since it contains praziquantel, the product is effective against Echinococcus multilocularis which does not occur in the UK but is becoming more common in some European countries.
Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum. Tapeworm infection is certain to re-occur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
Marketing Authorisation Number
Vm 00010/4115
Significant changes
GTIN
GTIN description:Drontal Plus Flavour Bone Shaped Tablets (2 Tablets)
GTIN:04007221036197
GTIN description:Drontal Plus Flavour Bone Shaped Tablets (6 Tablets)
GTIN:04007221036395
GTIN description:Drontal Plus Flavour Bone Shaped Tablets (24 Tablets)
GTIN:04007221036210
GTIN description:Drontal Plus Flavour Bone Shaped Tablets (108 Tablets)
GTIN:04007221036227