NAME: FIPROTEC 268 MG ACTIVE INGREDIENTS: One pipette contains: fipronil 268 mg EXCIPIENTS: Butylhydroxyanisole (E320), Butylhydroxytoluene (E321), Benzyl alcohol (E1519), Diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS: For the treatment and prevention of flea infestations (Ctenocephalides felis) in dogs. The duration of protection against flea infestations is 5 weeks. The product protects dogs from new tick infestations (Dermacentor reticulatus, Rhipicephalus sanguineus) from the seventh to the twenty-eighth day after application of the product. CONTRAINDICATIONS / ADVERSE EFFECTS Do not use in dogs under 8 weeks of age and/or weighing less than 2 kg. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Do not use in sick animals (systemic diseases, fever, etc.) or convalescent animals. Do not use in rabbits as adverse reactions and sometimes death may occur. Do not use in cats as it may cause overdose. DOSAGE For topical use. Apply according to the weight of the animal. Weight 20-40 kg: 1 pipette of 268 mg. Method of administration: Hold vertically. Gently tap the narrow end of the pipette to ensure that the product is inside the main body of the pipette. Break the pipette along the break line. Part the fur between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze gently to obtain one or two drops and empty the contents onto the skin. It is important to ensure that the product is applied to an area that the animal cannot lick and that the dog also does not come into contact with other treated animals. Take care to avoid over-wetting the fur with the product as this will cause a sticky appearance. If this occurs, this effect will disappear 48 hours after application. For optimal control of flea and/or tick infestations, the treatment plan may be based on the local epidemiological situation. In the absence of safety studies, the minimum treatment interval is 4 weeks. STORAGE: Do not store above 25 degrees C. Keep the pipettes in the blister in order to protect from light. Use immediately after first opening. WARNINGS: For optimal control of flea infestations in multi-pet households, all dogs and cats should be treated with an available insecticide. Fleas often infest beds, blankets, mattresses and carpets, which should be treated with an insecticide in the event of a massive infestation and at the start of control measures; vacuum regularly. No data are available on the efficacy of the product after bathing or shampooing. The product does not prevent ticks from attaching to animals. Efficacy against ticks present on the animal has not been demonstrated; therefore, the transmission of infectious diseases cannot be completely excluded. The product has been shown to protect against new tick infestations for a period of seven to twenty-eight days after application. However, protection against new infestations has not been shown to persist for more than four weeks. Therefore, there may be gaps in protection against these infestations, even if the product is reapplied every 4 weeks. For external use only. Do not apply the product to wounds or broken skin. Avoid contact with the animals eyes. In case of accidental contact, rinse immediately with water. Weigh animals carefully before treatment. It is important to ensure that the product is applied to an area where the animal cannot lick it. The potential toxicity of the product to puppies under 12 weeks of age in case of contact with a treated bitch has not been documented; take special precautions in these cases. Special precautions for those administering the product to animals: People with known hypersensitivity to fipronil or any of the excipients should avoid contact with the product. Avoid contact with fingers; in this case, wash with soap and water. The product may cause irritation of mucous membranes and eyes. Avoid contact with mouth and eyes. In case of accidental contact, rinse immediately with water. Ingestion of the product is harmful; keep pipettes out of the reach of children and throw them away immediately after application. Treated animals should not be left alone until the application site is dry; do not allow children to come into contact with the animal after application. It is recommended to treat the animal in the evening and do not allow animals to sleep with their owners, especially children. Do not smoke, drink or eat during use. Wash hands after application. Other precautions: Dogs should not swim in waterways for 2 days after application. Overdose: No adverse reactions were observed after application to 12-week-old puppies, growing dogs and dogs weighing approximately 5 kg treated three times at a dose five times the recommended dose. Incompatibilities: In the absence of compatibility studies, do not mix with other veterinary medicinal products. TARGET SPECIES: Dogs. INTERACTIONS: Do not use simultaneously with other flea treatment products if applied directly to the animal. ADVERSE EFFECTS: If the animal licks the application site, a short period of hypersalivation may be observed due to the excipient content. Extremely rare adverse reactions include cutaneous reactions at the application site (skin discoloration, local alopecia, pruritus, erythema). Exceptionally, hypersalivation, reversible neurological signs (hyperaesthesia, depression), vomiting and respiratory signs have been observed. PREGNANCY AND BREAST-FEEDING: Laboratory studies have not shown any teratogenic or fetotoxic effects. In the absence of specific studies on use during pregnancy or breast-feeding, use is based on an assessment of the risk/benefit ratio