NAME OF THE VETERINARY MEDICINAL PRODUCT Prazitel Plus XL COMPOSITION Each pork-flavoured tablet contains 175 mg Praziquantel, 504 mg Pyrantel embonate (equivalent to 175 mg Pyrantel) and 525 mg Febantel. A yellow, oblong tablet with a score line on both sides. The tablets can be divided into two equal parts. TARGET SPECIES Dogs INDICATIONS FOR USE In adult dogs : Treatment of mixed infestations with nematodes and cestodes of the following species: Nematodes: Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms) Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adult forms) Whipworms: Trichuris vulpis (adult forms). Cestodes: Tapeworms: Echinococcus species (E. granulosus, E. multilocularis), Taenia species (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms). CONTRAINDICATIONS Do not use simultaneously with piperazine-based compounds. Do not use in cases of hypersensitivity to the active substances or to any of the excipients. SPECIAL WARNINGS Special Warnings: Fleas serve as intermediate hosts for a common type of tapeworm – Dipylidium caninum. Tapeworm infestation will certainly recur if intermediate hosts such as fleas, mice, etc. are not controlled. Care should be taken to avoid the following practices, as they increase the risk of developing resistance and could ultimately lead to ineffective therapy: • Too frequent and repeated use of anthelmintics from the same class over a long period of time • Underdosing, which may be due to underestimation of body weight, incorrect administration of the product. Special precautions for safe use in target species: To ensure the administration of a correct dose, body weight should be determined as accurately as possible. 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. For good hygiene, persons administering the tablets directly to the dog or adding them to the dogs food should wash their hands afterwards. For veterinary use only. Pregnancy: Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats. No studies have been conducted in bitches during early gestation. Use of the product during pregnancy should be in accordance with a benefit-risk assessment by the responsible veterinarian. Use is not recommended during the first 4 weeks of pregnancy in bitches. Do not exceed the indicated dose when treating pregnant bitches. Interactions 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 antagonistic. Concomitant use with other cholinergic compounds may lead to toxicity. Overdose: The combination of praziquantel, pyrantel embonate and febantel is well tolerated by dogs. In safety studies, a single dose of 5 times the recommended dose or more occasionally caused vomiting. Other precautions: Echinococcosis is a hazard to humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidance on treatment and monitoring, as well as protection of individuals, should be obtained from the relevant competent authority. ADVERSE EVENTS Dogs: Very rare (35 kg should be given 1 Prazitel Plus XL tablet, plus the appropriate amount of Cazitel Plus tablets equivalent to 1 tablet per 10 kg body weight. Dogs weighing approximately 17.5 kg should be given ½ Prazitel Plus XL tablet. The tablets can be administered directly to the dog or incorporated into the food. Fasting is not necessary before or after treatment. Dosage table: Body weight (kg) Tablets Approximately 17.5 kg. ½ tablet Prazitel Plus XL 31-35 kg. 1 tablet Prazitel Plus XL 36-40 kg. 1 tablet Prazitel Plus XL, plus ½ tablet Cazitel Plus 41-45 kg. 1 tablet Prazitel Plus XL, plus 1 tablet Cazitel Plus 46-50 kg. 1 tablet Prazitel Plus XL, plus 1½ tablets Cazitel Plus 51-55 kg. 1 tablet Prazitel Plus XL, plus 2 tablets Cazitel Plus 56-60 kg. 1 tablet Prazitel Plus XL, plus 2½ tablets Cazitel Plus 61-65 kg. 1 tablet Prazitel Plus XL, plus 3 tablets Cazitel Plus 66-70 kg. 2 Prazitel Plus XL tablets The tablets can be divided into two equal parts. If there is a risk of reinfestation, veterinary advice should be sought on the need and frequency of repeated administration. 9. RECOMMENDATIONS FOR CORRECT ADMINISTRATION To ensure correct dosing, body weight should be determined as accurately as possible. 10. WITHDRAWAL PERIODS Not applicable . 11. SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children. This veterinary medicinal product does not require any special temperature storage conditions. Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Shelf life of half tablets: 14 days. Any unused half tablet should be returned to the open space of the blister and the blister should be placed back in the carton. 12. SPECIAL PRECAUTIONS FOR DISPOSAL Medicines should not be disposed of via wastewater. Use the return system for unused veterinary medicinal products or waste materials derived from such products, in accordance with local requirements and applicable national collection systems. These measures should help protect the environment. Ask your veterinarian or pharmacist how to dispose of medicines no longer required. 13. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS Veterinary medicinal product that is dispensed without a prescription. 14. MARKETING AUTHORISATION NUMBERS AND PACKAGE SIZES 180107 2, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 40, 42, 44, 48, 50, 52, 56, 60, 64, 68, 70, 72, 76, 80, 84, 88, 92, 96, 98, 100, 104, 106, 108, 112, 116, 120, 140, 150, 180, 200, 204, 206, 208, 250, 280, 300, 500 or 1000 tablets. Not all pack sizes may be marketed. Product compliance information Product compliance information Product safety Manufacturer information Personal information Product safety information Currently, product safety information is not available. Manufacturer information Currently, manufacturer information is not available. Responsible person information Currently, information about the person responsible is not available. n Size: Small, Medium, Large Presentation type: Tablet Action: Intestinal Worms Pieces Set: 10 pieces Brand Name: Chanelle n Quantity: 10 Tablets