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NAME DRONTAL MEAT MULTI-Flavor XL 525/504/175 MG TABLETS FOR DOGS ACTIVE INGREDIENTS Each tablet contains the active ingredients: 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, anhydrous colloidal silica, croscarmellose sodium, meat flavor. THERAPEUTIC INDICATIONS Treatment of mixed infections with 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 / ADVERSE REACTIONS 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 trimesters of pregnancy (see section 4.7). SAFETY IN TARGET SPECIES Doses of the product 10 times higher than the recommended dose have been tolerated by dogs and puppies without signs of adverse reactions. DOSAGE 35-52.5 kg; number of tablets: 1. Body weight: 52.5-70 kg; number of tablets: 2. For each additional 17.5 kg of body weight, half an additional tablet is administered. Administration and duration of treatment: The tablets are flavoured 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. There is no need to restrict access to a normal diet before or after treatment. The tablets should be administered once only. After opening the blister, any remaining half tablets should be discarded immediately or returned to the opened blister until use. A veterinarian should be consulted regarding the need 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 half tablets: 7 days. WARNINGS: Fleas act as intermediate hosts for a common type of tapeworm: Dipylidium caninum. Tapeworm infestation will recur if intermediate hosts such as fleas, mice, etc. are not controlled. Special precautions for use in animals: Parasite resistance to a particular class of anthelmintics may develop following frequent and repeated use of an anthelmintic of that class. To minimise the risk of re-infestation, excretions should be collected and disposed of appropriately 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 interest of good hygiene, persons administering the product directly to a dog or by adding it to the dogs food should wash their hands afterwards. Other precautions: As it contains praziquantel, the product is effective against Echinococcus spp., which are not present in all EU Member States but are becoming increasingly common in some. Echinococcosis poses a risk to humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidance on treatment, monitoring and human safety should be obtained from the relevant competent authority. Doses of ten times the recommended dose of the product have been tolerated by dogs and puppies without signs of adverse reactions. Major incompatibilities: Not applicable. TARGET SPECIES: Dogs. INTERACTIONS: The anthelmintic effects of this product and piperazine-containing products may be antagonised when the two products are used together. DIAGNOSIS AND PRESCRIBING: Veterinary medicinal product available without a prescription. ADVERSE REACTIONS: In very rare cases, mild and transient disorders of the digestive tract (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 treated, including isolated reports). PREGNANCY AND LACTATION: Teratogenic effects attributed to high doses of febantel administered during the first trimester of pregnancy have been reported in rats, sheep and dogs. The safety of the product has not been studied during the first and second trimesters of pregnancy. Do not use in pregnant bitches during the first and second trimesters of pregnancy (see section 4.3). A single treatment during the last trimester of pregnancy or during lactation has been shown to be safe
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