Name
DRONTAL MULTI MEAT FLAVOUR 150/144/50 MG TABLETS FOR DOGS UP TO 10 KG
Pharmacotherapeutic Group
Anthelmintics, praziquantel combinations.
Active Substances
Each tablet contains the active substances: febantel 150 mg; pyrantel 50 mg, equivalent to 144 mg of pyrantel embonate; praziquantel 50 mg. Excipients: for the full list of excipients, see section 6.1.
Excipients
Maize starch, lactose monohydrate, microcrystalline cellulose, povidone K25, magnesium stearate, sodium lauryl sulphate, colloidal anhydrous silica, croscarmellose sodium, meat flavouring.
Indications
Treatment of mixed infestations by nematodes and cestodes of the following species. Nematodes: ascarids (adults and late immature forms): toxocara canis, toxascaris leonina; hookworms (adults): uncinaria stenocephala, ancylostoma caninum; whipworms (adults): trichuris vulpis. Cestodes (adults and immature forms): echinococcus granulosus; echinococcus multilocularis; dipylidium caninum; taenia spp.
Contraindications/Undesirable Effects
Do not use in case of hypersensitivity to the active substances or to any of the excipients. Do not use during the first and second thirds of pregnancy (see section 4.7).
Safety in the Target Species
Doses of product 10 times the recommended dose were tolerated by dogs and puppies without signs of adverse reactions.
Dosage
For oral administration only. Dosage: for the treatment of dogs: 1 tablet per 10 kg of body weight (15 mg of febantel, 14.4 mg of pyrantel embonate and 5 mg of praziquantel/kg of body weight). The dosages are as follows. Body weight: 2-5 kg; number of tablets: ½. Body weight: >5-10 kg; number of tablets: 1. Body weight: >10-15 kg; number of tablets: 1½. Body weight: >15-20 kg; number of tablets: 2. For every additional 5 kg of body weight, give an additional half tablet. Administration and duration of treatment: the tablets are flavoured and studies have shown that they are palatable and are taken voluntarily by the majority (88%) of dogs tested. The tablets can be given with or without food. Access to a normal diet does not need to be restricted before or after treatment. The tablets should be given as a single administration. A veterinary surgeon should be consulted regarding the need for and frequency of repeat treatment. Do not use in dogs weighing less than 2 kg.
Storage
This veterinary medicinal product does not require any special storage conditions. After opening the blister, any remaining half tablets should be wrapped in aluminium foil and returned to the open blister. Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life of halved tablets: 7 days.
Warnings
Fleas act as intermediate hosts for a common type of tapeworm - Dipylidium caninum. If intermediate hosts such as fleas, mice etc. are not controlled, tapeworm infestation will certainly recur. Special precautions for use in animals: following frequent, repeated use of an anthelmintic of any particular class, parasite resistance to that class of anthelmintic may develop. To minimise the risk of reinfestation or new infestation, faeces should be collected and properly disposed of for 24 hours after treatment. Special precautions to be taken by the person administering the veterinary medicinal product to animals: in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the doctor. In the interests of good hygiene, persons administering the product directly to a dog or by adding it to the dog's food should wash their hands afterwards. Other precautions: as it contains praziquantel, the product is effective against Echinococcus spp., which do not occur in all EU member states but are becoming more common in some. Echinococcosis represents a hazard for humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on treatment, follow-up and the safeguarding of persons should be obtained from the relevant competent authority. Doses of product 10 times the recommended dose were tolerated by dogs and puppies without signs of adverse reactions. Incompatibilities: not applicable.
Withdrawal Periods
Not applicable.
Target Species
Dogs.
Interactions
The anthelmintic effects of this product and of products containing piperazine may be antagonised when the two drugs are used together.
Diagnosis and Prescription
Veterinary medicinal product not subject to veterinary prescription.
Undesirable Effects
In very rare cases, mild and transient digestive tract disorders (e.g. vomiting) may occur. The frequency of adverse reactions is defined using the following convention: very rare (fewer than 1 animal in 10,000 animals, including isolated reports).
Pregnancy and Lactation
Teratogenic effects attributed to high doses of febantel given during early pregnancy have been reported in rats, sheep and dogs. The safety of the product has not been studied during the first and second thirds of pregnancy. Do not use in pregnant bitches during the first and second thirds of pregnancy (see section 4.3). A single treatment during the last third of pregnancy or during lactation has been shown to be safe.
