NAME PRAZITELP ACTIVE INGREDIENTS Praziquantel 50 mg, Pirantel 50 mg (equivalent to 144 mg of pyrantel embonate), Febantel 150 mg. EXCIPIENTS Lactose monohydrate, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, croscarmellose sodium, sodium lauryl sulfate THERAPEUTIC INDICATIONS Treatment of mixed infections caused by nematodes and cestodes of the following species: NEMATODES. Ascarids: Toxocara canis and Toxascaris leonina (adult and immature forms). Hookworms: Uncinaria stenocephala and Ancylostoma caninum (adults). Trichuris: Trichuris vulpis (adults). TAPEWAVES. Tapeworms: Echinococcus spp. (E. granulosus, E. multilocularis), Taenia spp. (T. hydatigena, T. pisiformis, T. taeniformis) and Dipylidium caninum (adult and immature forms). CONTRAINDICATIONS / ADVERSE REACTIONS Do not administer simultaneously with piperazine compounds. Do not use in case of hypersensitivity to the active ingredients or to any of the excipients. DOSAGE Administer orally only. For dosage, follow the following indications: 15 mg/kg/kg body weight for febantel, 5 mg/kg for pyrantel (equivalent to 14.4 mg pyrantel embonate) and 5 mg/kg for praziquantel equivalent to one (1) tablet per 10 kg body weight. The tablets can be administered directly to the dog or hidden in food. A fasting period is not necessary, either before or after treatment. If there is a risk of reinfestation, consult a veterinarian for guidance on the need and frequency of subsequent administrations. To ensure correct dosage, body weight should be determined as accurately as possible. STORAGE: This veterinary medicinal product does not require any special storage conditions. WARNINGS: Fleas are the intermediate hosts of a common type of tapeworm, Dipylidium caninum. Tapeworm infestation will certainly recur unless control measures are implemented on intermediate hosts such as fleas, mice, etc. Tapeworm infestation is unlikely in puppies under 6 weeks of age. Resistance of a parasite to a particular class of anthelmintic may develop following frequent and repeated use of an anthelmintic of that class. 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 to the doctor. In accordance with hygiene rules, wash hands after administering the tablets directly to the dog or after adding them to its food. Overdose: The combined administration of praziquantel, pyrantel embonate and febantel is well tolerated by dogs. In safety studies, doses five or more times the recommended dose occasionally caused vomiting. TARGET SPECIES: Dogs. INTERACTIONS: Do not administer piperazine compounds concurrently, as the anthelmintic effects of pyrantel and piperazine may be antagonized. Concomitant use of other cholinergic compounds may cause toxicity. ADVERSE REACTIONS: None known. PREGNANCY AND LACTATION: Teratogenic effects attributed to high doses of febantel have been reported in sheep and mice. No studies have been conducted in dogs during early pregnancy. Use of the product during pregnancy should be subject to a risk/benefit assessment. It is recommended that the product not be used in bitches during the first 4 weeks of pregnancy. Do not exceed the recommended dose when treating pregnant bitches