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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: methyl pyrrolidone, butylhydroxytoluene (E321), medium-chain triglycerides. THERAPEUTIC INDICATIONS: In dogs: for the treatment and prevention of flea and/or tick infestations where repellent (antifeeding) activity against sand flies, horse flies, and/or mosquitoes is required. Fleas: treatment and prevention of Ctenocephalides felis flea infestations and prevention of Ctenocephalides canis flea infestations. One treatment prevents subsequent flea infestations for 4 weeks. The product can be used as part of a strategic treatment for flea allergy dermatitis, where 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 (Ixodes ricinus, Rhipicephalus sanguineus) ticks for 4 weeks after treatment and repels Dermacentor reticulatus for a period of 7 days up to 4 weeks after treatment. Mosquitoes and sandflies: Repels (anti-feeding activity) sandflies (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 by Leishmania infantum carried by sand flies (Phlebotomus perniciosus) for up to 4 weeks. The effect is indirect due to the products activity against the vector. Horse flies: repels (anti-feeding activity) and eliminates horse flies (Stomoxys calcitrans) for 5 weeks. CONTRAINDICATIONS / SIDE EFFECTS: Do not use in sick or convalescent animals. This product is for use only in dogs. 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 of fipronil/kg of body weight and 50.48 mg/kg of permethrin, equivalent to 0.1 ml of spot-on solution per kg of body weight. The product is intended for use exclusively for the treatment of confirmed infestations or where there is a risk of flea and/or tick infestation, where repellent (anti-feeding) activity against sand flies and/or mosquitoes and/or horse flies is also required. Repeated treatment may be indicated depending on 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 based on the dogs weight. 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 locations out of the dogs licking range. These locations 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 dotted line with scissors or tear open after folding 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 the product is applied directly to the skin and not 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 sandflies or mosquitoes may bite the dog. For this reason, if particularly unfavorable conditions occur, the transmission of pathogens through these arthropods cannot be completely ruled out. Individual ticks may attach to the dog and detach themselves within the first 24 hours of infestation, and not all ticks may be eliminated within 48 hours of treatment if they are already present when the product is applied. Immediate protection against sandfly bites is not documented. To reduce the risk of infection with Leishmania infantum carried by sandflies (Phlebotomus perniciosus), treated dogs should be kept in a protected environment for the first 24 hours after initial application. The product maintains its effectiveness against fleas when treated animals are subjected to occasional immersion in water (e.g., swimming, bathing). However, it is recommended not to bathe or allow dogs to swim for 48 hours after treatment. Avoid frequent bathing or washing of treated dogs, as this may negatively impact the products effectiveness. To reduce reinfestations due to the appearance 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 further help reduce environmental infestation, it is also recommended to use a targeted environmental treatment against adult fleas and their larval stages. In the absence of specific studies, use of the product in dogs under 8 weeks of age or weighing less than 2 kg is not recommended. Care should be taken to avoid contact of the veterinary medicinal product with the dogs eyes. It is important to ensure 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 metabolizing certain compounds, including permethrin, the product can cause potentially fatal convulsions in this species. In case of accidental skin exposure, wash the cat with shampoo or soap and seek prompt 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 can 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 eyes become irritated during administration, rinse immediately with plenty of water. If eye irritation persists, consult a doctor. In case of skin exposure or if skin becomes irritated during administration of the product, wash the skin immediately thoroughly with soap and water. If skin irritation persists or recurs, consult a physician. People with known hypersensitivity to fipronil and/or permethrin should avoid contact with the product. The product is harmful if swallowed. Avoid hand-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 physician. Since the excipient N-methylpyrrolidone can induce fetotoxicity and teratogenicity in case of 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 pack, and after use, empty pipettes must be immediately and properly disposed of 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 following 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 in puppies (from eight weeks of age treated only once). Known side effects may include mild neurological disorders, vomiting, and diarrhea. 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 EFFECTS: 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 emesis may be observed. The frequency of adverse reactions is defined using the following conventions: - 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 conducted with fipronil and permethrin have not shown 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 repeatedly exposed to high doses. Use only according to the benefit/risk assessment
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