NAME: FRONTPRO CHEWABLE TABLETS FOR DOGS: ACTIVE INGREDIENTS: 25-50 kg; afoxolaner: 136 mg. For a full list of excipients, see section 6.1. EXCIPIENTS: Maize starch, purified soya protein, cooked beef flavour, povidone (E1201), macrogol 400, macrogol 4000, macrogol 15-hydroxystearate, glycerol (E422), medium chain triglycerides. THERAPEUTIC INDICATIONS: Treatment of flea infestations (Ctenocephalides felis and C. canis) in dogs for at least 5 weeks. Treatment of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) in dogs. One treatment eliminates ticks for up to one month. To be exposed to the active ingredient, fleas and ticks must attach to the host and initiate a blood meal. CONTRAINDICATIONS / ADVERSE REACTIONS Do not use in cases of hypersensitivity to the active ingredient or to any of the excipients. SAFETY IN TARGET SPECIES No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age treated with a dose equal to 5 times the maximum dose, repeated 6 times at intervals of two to four weeks. DOSAGE 25-50 kg; dosage and number of chewable tablets to be administered; frontpro 136 mg: 1. For dogs weighing more than 50 kg, an appropriate combination of chewable tablets with different/equal doses is used. The tablets should not be divided. Method of administration: The tablets are chewable and palatable to most dogs. The tablets can be administered with food if the dog does not accept direct administration. Treatment regimen. Treatment of flea and tick infestations: For optimal control of flea and tick infestations, the product should be administered at monthly intervals during the peak flea and/or tick infestation seasons, depending on the local epidemiological situation. 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. WARNINGS: In order for parasites to be exposed to afoxolaner, they must initiate a blood meal on the host; therefore, the risk of transmission of diseases from the parasite cannot be excluded. When treating parasitic infestations, all animals in contact should be treated simultaneously with an appropriate product. Fleas, at any stage of growth, can infest the dogs bedding and usual resting areas, such as carpets and upholstered furniture. In case of heavy flea infestations and at the start of the antiparasitic treatment, these areas should be treated with a suitable environmental product and then cleaned regularly with a vacuum cleaner. Special precautions for use in animals: In the absence of available data, a veterinarian should be consulted before treating puppies under 8 weeks of age and/or dogs weighing less than 2 kg. Special precautions to be taken by the person administering the veterinary medicinal product to animals: To prevent children from accessing the veterinary medicinal product, remove only one tablet from the blister at a time. Return the blister with the remaining chewable tablets to the carton. Wash hands after handling the product. No adverse reactions have been observed in healthy Beagle puppies over 8 weeks of age treated with a dose equal to five times the maximum dose, six times at intervals of two to four weeks. Major incompatibilities: Not applicable. TARGET SPECIES: Dogs. INTERACTIONS: None known. ADVERSE REACTIONS: Neurological signs (convulsions, ataxia and muscle tremors), pruritus, lethargy, anorexia and mild gastrointestinal disturbances (vomiting, diarrhoea) have been reported very rarely. The majority of adverse reactions reported were self-limited and of short duration. The frequency of adverse reactions is defined using the following convention: very common (more than 1 in 10 animals treated displaying adverse reactions); common (more than 1 but less than 10 animals in 100 animals treated); uncommon (more than 1 but less than 10 animals in 1,000 animals treated); rare (more than 1 but less than 10 animals in 10,000 animals treated); very rare (less than 1 animal in 10,000 animals treated, including isolated reports). PREGNANCY AND LACTATION: Laboratory studies in rats and rabbits have not shown any teratogenic effects or adverse effects on the reproductive capacity of male and female subjects. The safety of the veterinary medicinal product during pregnancy and lactation or in breeding dogs has not been established. Consult a veterinarian before treatment during pregnancy and lactation or before use in breeding dogs