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NAME: FRONTLINE TRI-ACT SPOT-ON SOLUTION FOR DOGS 2-5 KG. ACTIVE INGREDIENTS: Each 0.5 ml pipette contains: fipronil 33.8 mg, permethrin 252.4 mg. EXCIPIENTS: methylpyrrolidone, butylhydroxytoluene (E321), medium chain triglycerides. THERAPEUTIC INDICATIONS: In dogs: for the treatment and prevention of flea and/or tick infestations, where repellent activity (anti-feeding) against sand flies, ticks and/or mosquitoes is required. Fleas: treatment and prevention of flea infestations Ctenocephalides felis and prevention of flea infestations Ctenocephalides canis. One treatment prevents subsequent flea infestations for 4 weeks. The product can be used as part of a strategic treatment for flea allergy dermatitis, if previously diagnosed by a veterinarian. Ticks: Treatment and prevention of tick infestations (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus). One treatment eliminates (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus) and repels ticks (Ixodes ricinus, Rhipicephalus sanguineus) for 4 weeks after treatment and repels Dermacentor reticulatus for a period of 7 days to 4 weeks after treatment. Mosquitoes and sand flies: Repel (anti-feeding activity) sand flies (Phlebotomus perniciosus) for 3 weeks and mosquitoes (Culex pipiens, Aedes albopictus) for 4 weeks. Eliminates sand flies (Phlebotomus perniciosus) and mosquitoes (Aedes albopictus) for 3 weeks. Reduces the risk of infection with Leishmania infantum, transmitted by sand flies (Phlebotomus perniciosus) for up to 4 weeks. The effect is indirect due to the activity of the product against the vector. Ticks: repels (anti-feeding activity) and eliminates ticks (Stomoxys calcitrans) for 5 weeks. CONTRAINDICATIONS / ADVERSE EFFECTS: Do not use in sick or convalescent animals. This product is intended for use in dogs only. Do not use in cats and rabbits, as potentially fatal adverse reactions may occur. Do not use in cases of hypersensitivity to the active ingredients or to any of the excipients. DOSAGE: For external use only. The minimum recommended dose is 6.76 mg fipronil/kg body weight and 50.48 mg/kg permethrin, equivalent to 0.1 ml spot-on solution per kg body weight. The product is intended for exclusive use in the treatment of confirmed infestations or where there is a risk of flea and/or tick infestation, where repellent activity (anti-feeding) against sand flies and/or mosquitoes and/or biting midges is also required. Repeated treatment may be indicated depending on the exposure to ectoparasites. In these cases, the interval between two consecutive treatments should be at least 4 weeks. Method of administration: Spot-on use. Select the appropriate pipette size according to the weight of the dog. For dogs weighing more than 60 kg, use the appropriate combination of two pipette sizes, which corresponds as closely as possible to the dogs body weight. The product should be applied to two sites outside the dogs licking area. These sites are at the base of the head and at the base of the neck, between the shoulder blades. Remove the blisters from the packaging and separate one blister. Remove the pipette by cutting along the dogs lick with scissors or break it after bending the marked corner. Holding the pipette upright, away from the face and body, cut the tip of the pipette with scissors to open it. Part the fur on the dogs back until the skin is visible. Place the tip of the pipette on the skin. Squeeze the pipette, applying approximately half of the contents to the base of the head. To empty the pipette, repeat the application at the base of the neck, between the shoulder blades. For best results, ensure that the product is applied directly to the skin and not to the fur. STORAGE: Store in the original blister. Do not store above 25 degrees C. WARNINGS: Individual ticks may attach to the dog, or individual sand flies or mosquitoes may bite the dog. For this reason, if particularly unfavourable conditions occur, the transmission of pathogens via these arthropods cannot be completely excluded. Individual ticks may attach to the dog and detach within the first 24 hours of infestation and not all ticks may be removed within 48 hours of treatment if they are already present at the time of application of the product. Immediate protection against sand fly bites is not documented. In order to reduce the risk of infection with Leishmania infantum, transmitted by sand flies (Phlebotomus perniciosus), treated dogs should be kept in a protected environment for the first 24 hours after initial application. The product maintains its efficacy against fleas when treated animals are subjected to occasional immersion in water (e.g. swimming, bathing). However, it is recommended that dogs not be bathed or allowed to swim for 48 hours after treatment. Avoid frequent bathing or washing of treated dogs as this may have a negative impact on the efficacy of the product. To reduce reinfestation due to the emergence of new fleas, it is recommended to treat all dogs in the household. Other pets living in the same household should also be treated with an appropriate product. To help reduce infestation by environmental factors, the use of a specific treatment against adult fleas and their larval stages is also recommended. In the absence of specific studies, the use of the product is not recommended in dogs under 8 weeks of age or weighing less than 2 kg. Care should be taken to avoid contact of the veterinary medicinal product with the dogs eyes. It is important to ensure that the product is applied to an area where the animal cannot lick itself and to ensure that other animals do not lick the treated area after application. Due to the unique physiology of cats, which prevents them from metabolising certain compounds, including permethrin, the product may cause potentially fatal convulsions in this species. In case of accidental skin exposure, wash the cat with shampoo or soap and seek immediate veterinary attention. To prevent accidental exposure to the product, separate treated dogs from cats until the application site is dry. It is important to ensure that cats do not lick the application site of a dog that has been treated with this product. If such exposure occurs, seek immediate veterinary attention. Do not use in cats or rabbits. Special precautions to be taken by the person administering the veterinary medicinal product to animals: This product may cause skin and eye irritation; therefore, avoid contact with skin and eyes. Do not open the pipette by pointing it at or near the face. In case of eye exposure or if the eyes become irritated during administration, rinse immediately with plenty of water. If eye irritation persists, consult a physician. In case of skin exposure or if the skin becomes irritated during administration, wash the skin immediately and thoroughly with soap and water. If skin irritation persists or recurs, consult a doctor. People with known hypersensitivity to fipronil and/or permethrin should avoid contact with the product. The product is harmful if swallowed. Avoid hand-to-mouth contact. Do not smoke, drink or eat during application. Wash hands after use. If swallowed, if you feel unwell, rinse your mouth and consult a doctor. Since the excipient N-methylpyrrolidone may induce fetotoxicity and teratogenicity at exposure to significant doses, pregnant women should wear gloves to avoid contact with the product. Treated animals should not be handled until the application site is dry and children should not be allowed to play with treated animals until the application site is dry. It is therefore recommended not to treat animals during the day but rather in the early evening and not to allow recently treated animals to sleep with their owners, especially children. Store pipettes in the original blister packaging and after use, empty pipettes should be disposed of immediately and properly to prevent further access. Other precautions: The product may have adverse effects on aquatic organisms. Do not allow treated dogs to enter waterways for 2 days after treatment. Overdose: Safety has been demonstrated with doses up to 5 times the maximum dose in healthy adult dogs (treated up to 3 times at monthly intervals) and puppies (from eight weeks of age treated once). Known adverse reactions may include mild neurological disorders, vomiting and diarrhoea. These effects are transient and generally resolve without treatment within 1-2 days. The risk of adverse reactions may increase in case of overdose, therefore animals should always be treated with the correct size pipette corresponding to their body weight. TARGET SPECIES: Dogs (2-5 kg). INTERACTIONS: None known. ADVERSE REACTIONS: Transient skin reactions at the application site (skin discoloration, local alopecia, itching, redness) and generalized itching, alopecia and erythema have been reported very rarely after use. Reversible neurological disorders (increased sensitivity to stimuli, hyperactivity, muscle tremors, depression, ataxia and other nervous disorders), vomiting, anorexia and hypersalivation have been reported very rarely after use. If the dog were to lick the application site, transient hypersalivation and vomiting may be observed. 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 with fipronil and permethrin did not reveal any teratogenic or embryotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. N-methylpyrrolidone, an excipient present in the veterinary medicinal product, has been shown to be teratogenic in laboratory animals exposed repeatedly to high doses. Use only according to benefit/risk assessment
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