Name
DRONTAL MULTI AROMA CARNE XL 525/504/175 MG TABLETS FOR DOGS
Pharmacotherapeutic Group
Anthelmintics, praziquantel combinations.
Active Ingredients
Each tablet contains the active substances: 525 mg febantel; 175 mg pyrantel equivalent to 504 mg pyrantel embonate; 175 mg praziquantel. Excipients: for the full list of excipients, see section 6.1.
Excipients
Maize starch, lactose monohydrate, microcrystalline cellulose, povidone K25, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, croscarmellose sodium, meat flavour.
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/Adverse Effects
Do not use in cases 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 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 35 kg of body weight (15 mg febantel, 14.4 mg pyrantel embonate and 5 mg praziquantel/kg body weight). Dosages are as follows. Body weight: 7-17.5 kg; number of tablets: ½. Body weight: >17.5-35 kg; number of tablets: 1. Body weight: >35-52.5 kg; number of tablets: 1½. Body weight: 52.5-70 kg; number of tablets: 2. For each additional 17.5 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 most (88%) of the dogs tested. The tablets can be given with or without food. Access to a normal diet need not be restricted before or after treatment. The tablets should be given as a single administration. After opening the blister, any remaining half tablets must be discarded immediately or returned to the opened blister until use. Contact a veterinary surgeon regarding the need for, and frequency of, repeat treatment. Do not use in dogs weighing less than 7 kg.
Storage
This veterinary medicinal product does not require any special storage conditions. Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life of halved tablets: 7 days.
Warnings
Fleas serve as intermediate hosts for a common type of tapeworm: Dipylidium caninum. Tapeworm infestation will recur unless intermediate hosts such as fleas, mice, etc. are controlled. Special precautions for use in animals: parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. 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 to humans. As echinococcosis is a disease notifiable to the World Organisation for Animal Health (OIE), specific guidelines on treatment, follow-up and safeguarding of persons must be obtained from the relevant competent authority. Doses 10 times the recommended dose were tolerated by dogs and puppies without signs of adverse reactions. Major 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 medicines are used together.
Diagnosis and Prescription
Veterinary medicinal product not subject to veterinary prescription.
Adverse 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 treated, including isolated reports).
Pregnancy and Lactation
Teratogenic effects attributed to high doses of febantel administered 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.
