WARNINGS
Fleas act as intermediate hosts for a common type of tapeworm: dipylidium caninum. The tapeworm infestation will reoccur if control of intermediate hosts, such as fleas, mice, etc., is not implemented. Special precautions for use in animals: resistance of a parasite to a particular class of anthelmintics may develop following frequent, repeated use of an anthelmintic of that class. To minimize the risk of reinfestation or new infestation, feces should be collected and disposed of properly for 24 hours after treatment. Special precautions to be taken by the person administering the veterinary medicine to animals: in case of accidental ingestion, seek immediate medical attention showing the package leaflet or label. For good hygiene, those administering the product directly to a dog or adding it to the dog’s food should wash their hands afterwards. Other precautions: since it contains praziquantel, the product is effective against Echinococcus spp. which are not present in all EU member states, but are becoming more common in some. Echinococcosis represents a risk to humans. Since echinococcosis is a disease that must be reported to the World Organisation for Animal Health (OIE), specific treatment guidelines, follow-up, and safeguarding of people should be obtained from the relevant competent authority. Doses of the product 10 times those recommended have been tolerated by dogs and puppies without signs of adverse reactions. Main incompatibility: not applicable.
PHARMACEUTICAL CATEGORY
Anthelmintics, praziquantel combinations.
STORAGE
This veterinary medicine does not require any special storage conditions. Shelf life of the veterinary medicine packaged for sale: 3 years. Shelf life of half tablets: 7 days.
CONTRAINDICATIONS/ADVERSE EFFECTS
Do not use in case of hypersensitivity to the active ingredients or to any of the excipients. Do not use during the first and second third of pregnancy (see paragraph 4.7).
NAME
DRONTAL MULTI AROMA MEAT XL 525/504/175 MG TABLETS FOR DOGS
DIAGNOSIS AND PRESCRIPTION
Veterinary medicine without the obligation of a veterinary prescription.
EXCIPIENTS
Corn starch, monohydrate lactose, microcrystalline cellulose, povidone K25, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica, sodium croscarmellose, meat flavor.
ADVERSE EFFECTS
In very rare cases, mild and transient digestive disturbances (e.g., vomiting) may occur. The frequency of adverse reactions is defined using the following conventions: very rare (less than 1 animal in 10,000 animals, including isolated reports).
PREGNANCY AND LACTATION
Teratogenic effects attributed to high doses of febantel, administered during the early stages of pregnancy, have been reported in rats, sheep, and dogs. The safety of the product has not been studied during the first and second third of pregnancy. Do not use in pregnant bitches during the first and second third of pregnancy (see paragraph 4.3). A single treatment during the last third of pregnancy or during lactation has been shown to be safe.
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.
INTERACTIONS
The anthelmintic effects of this product and products containing piperazine may be antagonized when the two drugs are used together.
DOSAGE
For oral administration only. Dosage: for the treatment of dogs: 1 tablet for every 35 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: 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 every additional 17.5 kg of body weight, administer an additional half tablet. Administration and duration of treatment: the tablets are flavored and studies have shown that they are palatable and are spontaneously accepted by most (88%) of the tested dogs. The tablets can be administered with or without food. Before or after treatment, it is not necessary to restrict access to a normal diet. The tablets should be provided in a single administration. For the necessity and frequency of repeating the treatment, contact a veterinarian. Do not use in dogs weighing less than 7 kg.
ACTIVE INGREDIENTS
Each tablet contains active ingredients: febantel 525 mg; pyrantel 175 mg, equivalent to 504 mg of pyrantel embonate; praziquantel 175 mg. Excipients: for the complete list of excipients, see paragraph 6.1.
SAFETY IN TARGET SPECIES
Doses of the product 10 times those recommended have been tolerated by dogs and puppies without signs of adverse reactions.
TARGET SPECIES
Dogs.
WITHDRAWAL TIME
Not applicable.
USE/ROUTE OF ADMINISTRATION
For oral administration.