NAME: FRONTLINE SPOT-ON CANINES: ACTIVE INGREDIENTS: Fipronil. EXCIPIENTS: Ethanol, Polyvidone, Polysorbate 80, Butylhydroxyanisole, Butylhydroxytoluene, Diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS: Treatment and prevention of tick infestations (Rhipicephalus spp., Dermacentor spp., Ixodes spp.), fleas (Ctenocephalides spp.) and lice in adult dogs and puppies. Fipronil rapidly exerts its lethal action on ticks, preventing the development of the parasite and the possible transmission of tick-borne infections. It is active against the main species of ticks present in Italy, including Ixodes ricinus, responsible for the transmission of Lyme disease in dogs, cats and humans. Fipronil acts on fleas by rapidly killing adult fleas, thus preventing the laying of eggs and, therefore, the emergence of new infestations. Due to its lethal effect on adult fleas, fipronil effectively contributes to the control and resolution of flea allergy dermatitis (FAD), which, in dogs, is caused by the sensitizing action of antigens contained in the saliva of these parasites. In addition, with a single treatment, fipronil quickly and permanently controls and resolves lice infestations, in particular those caused by Trichodectes canis, the chewing louse of dogs. CONTRAINDICATIONS / ADVERSE EFFECTS: In the absence of data, do not use the product on puppies under 8 weeks of age and/or weighing less than 2 kg. Do not use in sick animals (systemic diseases, fever, etc.) or convalescent animals. Do not use in rabbits, as potentially fatal adverse reactions may occur. This product is intended for dogs only. Do not use in cats, to avoid overdose. Do not use in case of hypersensitivity to the active substance or to any of the excipients. DOSAGE: It is presented in single-dose pipettes containing different volumes of product, depending on the weight of the dog. 1 pipette of 0.67 ml for dogs weighing between 2 and 10 kg; 1 pipette of 1.34 ml for dogs weighing between 10 and 20 kg; 1 pipette of 2.68 ml for dogs weighing between 20 and 40 kg; 1 pipette of 4.02 ml for dogs weighing between 40 and 60 kg. The indicated dose corresponds to the minimum recommended dose of 6.7 mg/kg of fipronil. For dogs weighing more than 60 kg, use a 4.02 ml pipette and a pipette with the most appropriate lower concentration (0.67 ml, 1.34 ml or 2.68 ml): break the pre-cut end of the pipette. Apply the product to the skin between the shoulder blades, an area where the dog cannot lick itself, avoiding removing the product. The contents of the pipette must be applied directly to the skin and not to the fur: press the sides of the pipette until completely empty. A single application of the product protects the animal from new infestations with ticks, fleas and lice, in particular: - ticks: up to 1 month after treatment - fleas: up to 3 months after treatment. For adequate prevention of ectoparasites, monthly treatments are recommended during the most seasonal periods. In the absence of safety data, the minimum treatment interval should be 4 weeks. STORAGE: Store in a dry place, at temperatures not exceeding 30 degrees C. WARNINGS: It is important to apply the product in an area where the animal cannot lick it and to ensure that the animals do not lick each other after treatment. Avoid contact with the animals eyes. In case of accidental contact with eyes, rinse immediately with plenty of water. Do not apply the product to wounds or broken skin. It is recommended to avoid immersion in water or bathing for 2 days after application of the product and bathing more frequently than once a week as there are no data available to demonstrate how this affects the activity of the product. Emollient shampoos can be used prior to treatment, but if used weekly after application of the product, they reduce the duration of flea protection to approximately 5 weeks. Weekly bathing with medicated shampoos containing 2% chlorhexidine did not reduce the effectiveness of the product against fleas during a 6-week study. It is recommended that dogs are not allowed to swim in water for 2 days after application. If the dog has been treated before exposure to ticks, these will be shed within 24-48 hours after infestation or before the dog has finished eating, reducing but not eliminating the risk of disease transmission. Once dead, ticks will fall off the animals; any remaining ticks can be easily removed by gently plucking them off. Fleas on animals often infest bedding, blankets and living areas of animals, especially carpets, curtains and upholstered furniture. In case of heavy infestations and at the beginning of the antiparasitic treatment, these can be treated with a suitable insecticide and vacuumed regularly. For optimal control of flea infestations, it is advisable to treat all animals in the household. Special precautions for those administering the product to animals: The product may cause irritation of mucous membranes and eyes. It is therefore recommended to avoid contact with the mouth and eyes. In case of accidental contact with eyes, rinse immediately with plenty of water. If eye irritation persists, seek medical advice and show the label. Avoid contact with Frontline Spot On Dogs on animals or people with known sensitivity to insecticides or alcohol. Avoid contact of the contents with hands. If this happens, wash your hands with soap and water. Wash your hands after use. Do not touch animals and do not allow children to play with treated animals until the application site is dry. It is therefore recommended to treat animals not during the day but in the evening. If they have recently been treated, do not allow them to sleep with their owners, especially children. Do not smoke, drink or eat during application. Overdose: In safety studies, no adverse reactions were observed in 8-week-old puppies, growing dogs and dogs weighing approximately 2 kg, treated once at doses five times higher than the recommended dose. The risk of adverse reactions (see section 4.6) may, however, increase in case of overdose; therefore, animals should always be treated with the pipette appropriate to their body weight. TARGET SPECIES: Dogs. INTERACTIONS: None known. ADVERSE REACTIONS: If animals lick themselves, transient hypersalivation may be observed, mainly due to the excipients of the product. Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema) and extensive pruritus or alopecia after application have been described. In exceptional cases, hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms), vomiting or respiratory symptoms have been observed. PREGNANCY AND BREAST-FEEDING The product can be used during pregnancy and breast-feeding