Prazitel Plus Flavour Tablets 104S

4.1 Target species Dogs. 4.2 Indications for use, specifying the target species In dogs: Treatment of mixed infections by nematodes and cestodes of the following species Nematodes: Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms). Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults). Whipworms: Trichuris vulpis (adults). Cestodes: Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms). Revised: October 2019 AN: 00846/2019 Page 2 of 6 4.3 Contraindications Do not use simultaneously with piperazine compounds. Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients. 4.4 Special warnings for each target species Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken. Tapeworm infestation is unlikely in pups less than 6 weeks of age. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. 4.5 Special precautions for use Special precautions for use in animals None. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental ingestion, seek medical advice and show the package leaflet to the physician. In the interests of good hygiene, persons administering the tablets directly to the dog, or by adding them to the dog’s food, should wash their hands afterwards. Echinococcosis represents a hazard for humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority. 4.6 Adverse reactions (frequency and seriousness) In very rare cases, gastrointestinal disorders (diarrhoea, emesis) have been observed. 4.7 Use during pregnancy, lactation or lay Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats. No studies have been performed in dogs during early pregnancy. Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian. It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy. Do not exceed the stated dose when treating pregnant bitches.Revised: October 2019 AN: 00846/2019 Page 3 of 6 4.8 Interaction with other medicinal products and other forms of interaction Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized. Concurrent use with other cholinergic compounds can lead to toxicity.