NAME: AMFLEE COMBO 67 MG/60.3 MG SPOT-ON SOLUTION FOR SMALL DOGS: ACTIVE INGREDIENTS: Each 0.67 ml pipette contains: Fipronil 67 mg, S-methoprene 60.3 mg. EXCIPIENTS: Butylhydroxyanisole (E320), Butylhydroxytoluene (E321), Povidone (K25), Polysorbate 80, Ethanol 96%, Diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS: For the treatment of dogs, the dose is defined according to body weight. To be used for flea infestations alone or in combination with ticks and/or biting lice. Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations of adult fleas persists for 8 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) from eggs laid by adult fleas for eight weeks after application. Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus). The product has persistent acaricidal efficacy for up to 4 weeks against ticks. Treatment of biting lice infestations (Trichodectes canis). The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD), if previously diagnosed by a veterinarian. CONTRAINDICATIONS / ADVERSE EFFECTS: In the absence of available data, the product should not be used in puppies under 8 weeks of age and/or weighing less than 2 kg. Do not use in sick (e.g. systemic diseases, fever) or convalescent animals. Do not use in rabbits, due to the risk of adverse reactions or even death. This product is specifically designed for dogs. Do not use in cats and ferrets, as overdose may occur. Do not use in case of hypersensitivity to the active substance or to any of the excipients. DOSAGE: For external use only, spot-on. Administer by topical application to the skin: one pipette of 0.67 ml (67 mg fipronil + 60.3 mg S-methoprene) per dog weighing between 2 and 10 kg. This corresponds to the minimum recommended dose of 6.7 mg/kg fipronil and 6 mg/kg S-methoprene, for topical administration to the skin. In the absence of safety studies, the minimum treatment interval is 4 weeks. Instructions for use: Remove the pipette from the sachet. Hold the pipette upright, twist and remove the cap. Turn the cap upside down and replace it on the other end of the pipette. Press and twist the cap to break the seal, then remove the cap from the pipette. Part the animal’s fur on the back of the animal at the base of the neck, in front of the shoulder blades, until the skin is visible. Place the tip of the pipette on the skin and press the pipette several times to empty the contents completely and directly onto the skin in one spot. Temporary changes in the fur at the application site (clumping/greasyness) may be observed. STORAGE: Store in the original package in order to protect from light and moisture. This veterinary medicinal product does not require any special temperature storage conditions. WARNINGS: Bathing/immersion in water should be avoided within 2 days of application of the product and bathing more frequently than once a week should be avoided as no studies have been performed to investigate how these affect the efficacy of the product. Emollient shampoos can be used before treatment, but the duration of flea protection is reduced by approximately 5 weeks when used weekly after application. Weekly bathing with a medicated shampoo containing 2% chlorhexidine did not affect flea efficacy during a 6-week study. Attachment of individual ticks may occur. Therefore, transmission of infectious diseases cannot be completely excluded under adverse conditions. Fleas present on animals often infest bedding, bedding and the animals usual resting areas, such as carpets and upholstered furniture. In the case of massive infestations and at the beginning of control measures, these should be treated with a suitable insecticide and vacuumed regularly. Avoid contact with the animals eyes. It is important to ensure that the product is applied in an area where the animals cannot lick it and to ensure that the animals do not lick each other after treatment. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals: This product may cause irritation of mucous membranes, skin and eyes. Therefore, contact of the product with the mouth, skin and eyes should be avoided. People with known hypersensitivity to insecticides or alcohol should avoid contact with the product. Avoid contact of the contents with fingers. If this happens, wash hands immediately with soap and water. In case of accidental contact with eyes, rinse immediately with plenty of clean water. Wash hands after use. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. Do not smoke, drink or eat during application. 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 evening and not to allow recently treated animals to sleep with their owners, especially children. Other precautions: Dogs should not be allowed to swim in water for 2 days after application. Overdose: In safety studies conducted on target species, no adverse reactions were observed in 8-week-old puppies, growing dogs and dogs weighing approximately 2 kg, treated once with doses five times the recommended dose. The risk of adverse reactions may increase, however, in case of overdose, therefore animals should always be treated with the correct pipette dosage according to body weight. TARGET SPECIES: Dogs (2-10 kg). INTERACTIONS: None known. ADVERSE REACTIONS: Among the extremely rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, local alopecia, pruritus, erythema), generalized pruritus or alopecia have been reported after use. Hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms), vomiting and/or respiratory symptoms have also been observed after use. If the animal licks itself, a short period of hypersalivation may be observed due to the nature of the excipients. Do not overdose. PREGNANCY AND LACTATION: The product can be used during pregnancy and lactation