NAME: FRONTLINE SPRAY (FIPRONIL 0.25%) ACTIVE INGREDIENTS: Active ingredient: fipronil 0.25 g. Excipients: isopropanol 80 ml; copolyvidone 2 g; deionized water up to 100 ml. THERAPEUTIC INDICATIONS: Treatment and prevention of tick, flea and lice infestations in dogs and cats aged 2 days or more. 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 egg laying and subsequent infestations. Due to its lethal effect on adult fleas, fipronil effectively helps to control and resolve flea allergy dermatitis (FAD), which, in dogs and cats, is caused by the sensitizing action of antigens contained in the saliva of these parasites. Fipronil also controls and resolves lice infestations in dogs and cats quickly and permanently with a single treatment, especially those caused by Trichodectes canis, the dog biting louse, and Felicola subrostratus, the cat biting louse. CONTRAINDICATIONS / ADVERSE EFFECTS: Do not use in animals with extensive skin lesions. Do not use in sick animals (systemic diseases, fever) or convalescent animals. Do not use in rabbits, as potentially fatal adverse reactions may occur. SAFETY IN TARGET SPECIES The risk of adverse reactions (see section 5.4) may increase in case of overdose, therefore animals should always be treated with the dose corresponding to their body weight. Do not exceed the recommended doses. DOSAGE Dosage: Depending on the length of the hair, spray 3 to 6 ml of product/kg of body weight. This volume corresponds to: 2-4 sprays/kg of body weight if using the 250 ml or 500 ml bottle (1 spray equals 1.5 ml); 6-12 sprays/kg of body weight if using the 100 ml bottle (1 spray equals 0.5 ml). Spray “in reverse” over the entire surface of the animal’s body, from a distance of 10-20 cm, holding the bottle vertically. Spray evenly, covering the entire body. After spraying, rub the back, shoulders, hips, abdomen, paws and neck thoroughly to ensure that the product comes into direct contact with the skin. For the head and eye area, apply the product to a glove and rub gently in the opposite direction. After spraying, leave to dry naturally. A single application of the product protects the animal from new infestations with ticks, fleas and lice, especially ticks: up to 1 month after treatment, in both dogs and cats; Fleas: * up to 3 months after treatment for dogs; * up to 5 weeks after treatment for cats. For adequate prevention of ectoparasites, monthly treatments are recommended during peak periods of the season. In the absence of safety data, the minimum treatment interval should be 4 weeks. STORAGE: Store in a cool, dry place, away from flames or sources of heat. Shelf life: 36 months. WARNINGS: Do not spray the product in the eyes of animals, on mucous membranes or inside the ears. For external use only. Bathing, showering or shampooing do not affect the duration of the products activity against ectoparasites. It is important that animals do not lick each other after treatment. It is recommended that dogs are not allowed to swim in watercourses for 2 days after application of the product, as fipronil can be harmful to aquatic organisms. If not applied correctly, individual ticks could attach to the dog or cat. For this reason, in the worst case, the transmission of infectious diseases cannot be completely ruled out. Fleas on animals often infest the basket, bedding and living areas of the animal, especially carpets, curtains and soft furnishings. In the case of massive infestations or at the beginning of antiparasitic treatment, these can be treated with a suitable insecticide and cleaned regularly with a vacuum cleaner. Special precautions to be taken by the person administering the product to animals: Keep out of the reach of children. Keep away from flames or sources of heat; keep away from food, animal feed and drink; do not contaminate food, animal feed, drink or containers intended to contain them during use; ventilate the area adequately when dispensing the product; protect your hands with gloves when dispensing the product; do not inhale, ingest or allow anyone to swallow it; avoid contact with pregnant women and young children; in case of accidental ingestion, consult a doctor. The product may cause irritation of mucous membranes and eyes. It is therefore recommended to avoid contact with the mouth and eyes. It is recommended that animals or people with known sensitivity to insecticides or alcohol avoid contact with Frontline Spray. Avoid contact of the contents with hands. If this happens, wash your hands with soap and water. In case of accidental contact with eyes, rinse thoroughly with water. Wash hands after use. Do not touch animals and do not allow children to play with treated animals until their fur is dry. It is therefore recommended not to treat animals during the day, but rather to treat them in the evening. If they have been recently treated, do not allow them to sleep with their owners, especially children. Do not smoke, drink or eat during application. The risk of adverse reactions (see section 5.4) may increase in case of overdose, therefore animals should always be treated with the dose corresponding to their body weight. Do not exceed the recommended dose. Incompatibilities: None known. TARGET SPECIES: Dog - Cat. INTERACTIONS: No interactions 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 such as erythema, pruritus or alopecia have been described after application. Exceptionally, hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms), vomiting or respiratory symptoms have been observed. Do not exceed the recommended dose. PREGNANCY AND LACTATION: The product can be used in bitches and cats both during gestation and lactation. Frontline Spray is well tolerated by puppies and kittens after treatment of their mothers during lactation. Puppies and kittens as young as 2 days old can be treated without any risk