NAME: VECTRA 3D ACTIVE INGREDIENTS: Dinotefuran, pyriproxyfen, permethrin EXCIPIENTS: N-octyl-2-pyrrolidone, N-methylpyrrolidone THERAPEUTIC INDICATIONS: Fleas: Treatment and prevention of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The treatment prevents flea infestation for one month. It also prevents flea multiplication for two months after application by inhibiting egg hatching (ovicidal activity) and inhibiting the emergence of adults from eggs laid by adult fleas (larvicidal activity). The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD). Ticks: The veterinary medicinal product has persistent acaricidal efficacy and repellent action against tick infestations (Rhipicephalus sanguineus and Ixodes ricinus for one month and Dermacentor reticulatus for up to three weeks). If ticks are present at the time of application of the veterinary medicinal product, they may not all be killed within the first 48 hours, but may die within a week. To remove ticks, the use of a special tick removal device is recommended. Sandflies, mosquitoes and flies: The treatment provides persistent repellent activity (anti-feeding). It prevents bites by sandflies (Phlebotomus perniciosus), mosquitoes (Culex pipiens, Aedes aegypti) and flies (Stomoxys calcitrans) for one month after application. The treatment also provides persistent insecticidal activity for one month against mosquitoes (Aedes aegypti) and flies (Stomoxys calcitrans). CONTRAINDICATIONS / ADVERSE EFFECTS Do not use in case of hypersensitivity to one or more of the active substances or to any of the excipients. Do not use in cats. Due to their particular physiology and inability to metabolise permethrin, this veterinary medicinal product should not be used in cats. If applied to a cat or ingested by a cat that has actively rubbed against a recently treated dog, this veterinary medicinal product may cause serious adverse reactions. DOSAGE The minimum recommended dose is 6.4 mg dinotefuran/kg body weight, 0.6 mg pyriproxyfen/kg body weight and 46.6 mg permethrin/kg body weight, equivalent to 0.12 ml of veterinary medicinal product per kg body weight. Use the appropriate packaging according to the body weight of the animal. Take care to apply the veterinary medicinal product only to intact skin. Avoid superficial application to the dogs fur. Treatment regimen: After a single application, the veterinary medicinal product will prevent infestation for one month. The treatment can be repeated once a month. STORAGE: This veterinary medicinal product does not require any special storage conditions. WARNINGS: All dogs in the household should be treated. Household cats should only be treated with a veterinary medicinal product authorised for use in the relevant species. Fleas may infest the dogs basket, bedding and usual resting areas such as carpets, sofas and armchairs. In case of severe flea infestation and at the beginning of control measures, these areas should be treated with an appropriate insecticide and then vacuumed regularly. This veterinary medicinal product may induce convulsions in cats, which may be fatal, due to the particular physiology of this species, which is unable to metabolise certain compounds, including permethrin. In case of accidental exposure, if adverse reactions occur, wash the cat with shampoo or soap. To prevent accidental contact of cats with this veterinary medicinal product, keep cats away from treated dogs until the application site is dry. It is important to ensure that cats do not rub against the application site of a dog that has been treated with this veterinary medicinal product. The safety of this veterinary medicinal product has not been established in dogs less than 7 weeks of age or weighing less than 1.5 kg. Precautions should be taken to avoid contact between this veterinary medicinal product and the dogs eyes. Attachment of a single tick after treatment cannot be excluded. Therefore, transmission of infectious diseases cannot be completely excluded if conditions are favourable. The veterinary medicinal product maintains its efficacy when treated animals are immersed in water (e.g. swimming, bathing). Repeated weekly immersion in water for one month, starting 48 hours after treatment, as well as shampooing 2 weeks after treatment, do not affect the efficacy of this product. However, the duration of efficacy may be reduced by frequent shampooing or bathing within 48 hours of treatment. Special precautions to be taken by the person administering the product to animals: Do not eat, drink or smoke while handling the veterinary medicinal product. Wash hands thoroughly immediately after use. This veterinary medicinal product causes eye and skin irritation. Avoid contact with skin. In case of accidental spillage on the skin, wash immediately with soap and water. If the veterinary medicinal product accidentally comes into contact with the eyes, the eyes should be rinsed thoroughly with water. If eye or skin irritation persists or if the veterinary medicinal product is accidentally ingested, seek medical advice immediately and show the package leaflet or the label. People with known hypersensitivity to any of the ingredients should avoid contact with the veterinary medicinal product. Children should not handle treated dogs for at least four hours after administration of the veterinary medicinal product. It is therefore recommended to treat dogs in the evening or before taking them out for a walk. On the day of treatment, treated dogs should not be allowed to sleep with their owners, especially children. Used applicators should be discarded immediately and kept out of the sight and reach of children. Allow the application site to dry before allowing treated dogs to come into contact with fabrics or objects. Other precautions: Treated dogs should not be allowed to enter watercourses for 48 hours after treatment to avoid adverse reactions in aquatic organisms. Overdose: With the exception of erythema and changes in coat appearance, no adverse reactions were observed in healthy 7-week-old puppies treated topically 7 times at 2-week intervals and up to 5 times the maximum recommended dose. Accidental ingestion of the maximum recommended dose may result in vomiting, salivation and diarrhoea, which should resolve without treatment. Incompatibilities: Do not mix with other veterinary medicinal products and do not apply simultaneously or at the same site as other veterinary medicinal products. TARGET SPECIES: Dogs. INTERACTIONS: None known. ADVERSE REACTIONS: Erythema, pruritus or other transient signs of discomfort at the application site have been reported very rarely (less than 1 in 10,000 animals, including isolated reports), which usually disappear spontaneously within 24 hours of administration of the product. Gastrointestinal symptoms such as vomiting or diarrhoea have also been reported very rarely. Transient cosmetic effects (greasy appearance, matted hair and accumulation of excrement) at the application site have been reported very rarely, but these effects are usually no longer visible after 48 hours. PREGNANCY AND LACTATION: The safety of the veterinary medicinal product in bitches has not been established during pregnancy and lactation. The use of the veterinary medicinal product in pregnant and lactating bitches or in dogs intended for breeding should be based on a benefit/risk assessment. Laboratory studies with each of the components - dinotefuran, pyriproxyfen or permethrin - in rats and rabbits did not demonstrate maternotoxic, teratogenic or fetotoxic effects. Dinotefuran has been shown to cross the blood-mammary barrier and is excreted in milk. N-methylpyrrolidone, an excipient in the veterinary medicinal product, has been shown to be teratogenic in laboratory animals