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NAME DRONTAL MULTI MEAT FLAVOUR 150/144/50 MG TABLETS FOR DOGS UP TO 10 KG ACTIVE INGREDIENTS Each tablet contains active ingredients: febantel 150 mg; pyrantel 50 mg, equivalent to 144 mg of pyrantel embonate; praziquantel 50 mg. Excipients: for a 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. THERAPEUTIC INDICATIONS Treatment of mixed infections 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. Tapeworms (adults and immature forms): Echinococcus granulosus; Echinococcus multilocularis; Dipylidium caninum; Taenia spp. CONTRAINDICATIONS / SIDE 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 third of pregnancy (see section 4.7). SAFETY IN THE TARGET SPECIES: Product doses 10 times those recommended have been tolerated by dogs and puppies without signs of adverse reactions. DOSAGE: 15-20 kg; number of tablets: 2. For every additional 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 taken spontaneously by the majority (88%) of dogs tested. The tablets can be administered with or without food. It is not necessary to restrict access to a normal diet before or after treatment. The tablets should be administered as a single dose. A veterinarian should be consulted regarding the need 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 halved tablets should be wrapped in foil and returned to the opened 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 is certain to recur. Special precautions for use in animals: Following frequent and repeated use of an anthelmintic of any particular class, parasite resistance to that class of anthelmintics may develop. To minimize the risk of reinfestation or reinfestation, excreta should be collected and disposed of properly 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 physician. In the interests of good hygiene, those administering the product directly to a dog or adding it to the dogs food should wash their hands afterwards. Other precautions: Because 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 poses a risk to humans. Since echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on treatment, follow-up, and human safety must be obtained from the relevant competent authority. Product doses 10 times the recommended dose have been tolerated by dogs and puppies without signs of adverse reactions. Incompatibilities: Not applicable. TARGET SPECIES: Dogs. INTERACTIONS: The anthelmintic effects of this product and products containing piperazine may be antagonized when the two drugs are used together. DIAGNOSIS AND PRESCRIPTION: Veterinary medicinal product not requiring a veterinary prescription. SIDE 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 (less than 1 in 10,000 animals, 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 dogs 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
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