NAME EFFIPRO DUO 67 MG/20 MG SPOT-ON SOLUTION FOR SMALL DOGS ACTIVE INGREDIENTS Each 0.67 ml pipette contains: active ingredients: fipronil 67.0 mg; pyriproxyfen 20.1 mg. Excipients: butylhydroxyanisole 0.134 mg; butylhydroxytoluene 0.067 mg. For the full list of excipients, see section 6.1. EXCIPIENTS Butylhydroxyanisole E320, butylhydroxytoluene E321, diethylene glycol monoethyl ether. THERAPEUTIC INDICATIONS Treatment of flea infestations, alone or in combination with ticks. Against fleas: For the treatment and prevention of flea infestations (Ctenocephalides spp.). Treatment prevents further infestation for 7 weeks. Prevention of flea multiplication by preventing the development of eggs into adult fleas for 12 weeks after application. The product can be used as part of a strategic treatment for the control of flea allergy dermatitis (FAD) when previously diagnosed by a veterinarian. Against ticks: For the treatment of tick infestations (Ixodes ricinus). One treatment has persistent acaricidal efficacy for 2 weeks against Ixodes ricinus and 4 weeks against Dermacentor reticulatus (Rhipicephalus sanguineus). If certain tick species (Dermacentor reticulatus, Rhipicephalus sanguineus) are present at the time of administration of the product, not all ticks may be killed within 48 hours. CONTRAINDICATIONS / ADVERSE REACTIONS: Do not use in rabbits as adverse reactions and even death may occur. Do not use in case of known hypersensitivity to the active substance or to any of the excipients. SAFETY IN TARGET SPECIES No adverse reactions were observed in safety studies in the target species in 10-week-old puppies treated with 5 times the recommended dose 3 times at 4-week intervals and with the maximum recommended dose 6 times at 4-week intervals. The risk of adverse reactions (see section 4.6) may increase in case of overdose, therefore animals should always be treated with a pipette according to body weight. DOSAGE Route of administration: spot-on use. Dosage: apply 1 pipette of 0.67 ml per dog weighing between 2 kg and 10 kg, corresponding to the minimum recommended dose of 6.7 mg fipronil/kg body weight and 2 mg pyriproxyfen/kg body weight. Volume: 0.67 ml; dog weight: 2-10 kg; Fipronil: 67 mg; pyriproxyfen: 20.1 mg. Volume: 1.34 ml; dog weight: 10-20 kg; fipronil: 134 mg; pyriproxyfen: 40.2 mg. Volume: 2.68 ml; dog weight: 20-40 kg; fipronil: 268 mg; pyriproxyfen: 80.4 mg. Volume: 4.02 ml; dog weight: 40-60 kg; fipronil: 402 mg; pyriproxyfen: 120.6 mg. For dogs weighing more than 60 kg, the appropriate pipette combination should be used. Instructions for use: Remove the pipette from the blister. Hold the pipette upright. Shake the narrow end of the pipette to ensure that the contents are in the widest part of the pipette. Break the seal at the top of the spot-on pipette along the marked line. Part the dog’s fur until the skin is visible. Place the tip of the pipette directly on the exposed skin and press gently a few times to empty the contents. Repeat the operation in one or two different places on the dogs back to avoid removal or superficial application to the fur, especially in large dogs. Anti-drip system (the product is released only by pressing the body of the pipette). One pipette constitutes one treatment, with the possibility of repeating monthly administrations. For optimal control of flea and tick infestations, the treatment regimen may be based on the local epidemiological situation. STORAGE: Store below 30 degrees C. Store in a dry place. Keep the blister in the original packaging in order to protect from light. Shelf life of the veterinary medicinal product as packaged for sale: 3 years. WARNINGS: Shampooing or directly immersing the animal in water after treatment may reduce the duration of activity. The product remains active against fleas for 5 weeks when the dog is bathed monthly after treatment. Repeated immersion in water twice after application of the product does not affect the adulticidal activity against fleas or the efficacy in preventing the development of adult flea eggs. The influence of immersion in water or washing the dog on the efficacy of the product against ticks has not been evaluated. At the beginning of control measures, in the event of an infestation, beds, bedding and usual resting areas of the animals, such as carpets and soft furnishings, should be treated with an appropriate insecticide and vacuumed regularly. To reduce the presence of fleas in the environment, all animals living in the same household should be treated with an appropriate flea control product. The product does not prevent ticks from attaching to animals. The transmission of tick-borne infectious diseases cannot be completely excluded under unfavourable conditions. Immediate efficacy has been demonstrated against Ixodes ricinus, indicating that within 48 hours of application of the product, ticks of Dermacentor reticulatus or Rhipicephalus sanguineus are present at the time of application of the product, these ticks may not be killed within the first 48 hours. Once dead, the ticks will fall off the animals; any remaining ticks should be carefully removed, ensuring that their mouthparts are not left in the skin. Special precautions for use in animals: For external use only. Animals should be accurately weighed before treatment. In the absence of safety data, the product should not be used in puppies less than 10 weeks of age and/or weighing less than 2 kg. Precautions should be taken to prevent contact of the contents of the pipette with the eyes or mouth of treated dogs. In particular, oral ingestion caused by licking of the application site by treated animals or animals in contact should be avoided. Do not apply the product to wounds or damaged skin. In the absence of further safety studies, do not repeat the treatment at intervals of less than 4 weeks. The use of the product has not been studied in sick and debilitated dogs. Special precautions to be taken by the person administering the product to animals: the product may cause neurotoxicity. The product may be harmful if swallowed. Avoid contact with skin and mouth. Avoid ingestion, including hand-to-mouth contact. Do not smoke, drink or eat during application. Wash hands after use. 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 that animals should not be treated during the day, but rather in the early evening and that recently treated animals should not be allowed to sleep with their owners, especially children. Keep pipettes in the original packaging until use and discard used pipettes immediately. In case of accidental skin contact, rinse with water. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. Other precautions: Fipronil and pyriproxyfen may be harmful to aquatic organisms. Dogs should be prevented from entering waterways for 48 hours after treatment (see also section 6.6). The product may have adverse effects on household surfaces, varnished surfaces or other paintings or furniture. Allow the application site to dry before allowing contact with such materials. No adverse reactions were observed in target species safety studies in 10-week-old puppies treated with 5 times the recommended dose three times at 4-week intervals and with the maximum recommended dose six times at 4-week intervals. The risk of adverse reactions (see section 4.6) may increase in case of overdose, therefore animals should always be treated with a pipette according to body weight. Incompatibilities: None known. TARGET SPECIES: Dogs (2-10 kg). INTERACTIONS: None known. ADVERSE REACTIONS: Transient cosmetic effects such as a moist appearance or slight dandruff may occur at the application site. Based on experience with these active substances among spot-on pharmaceutical forms, temporary skin reactions at the application site (desquamation, local alopecia, itching, erythema, skin discoloration) and general itching or alopecia may be observed after use. In very rare cases, hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous symptoms), respiratory symptoms or vomiting may occur. PREGNANCY AND LACTATION: Laboratory studies with fipronil and pyriproxyfen have not shown evidence of teratogenic or embryotoxic effects. The safety of the veterinary medicinal product during pregnancy and lactation has not been established. Use only according to the benefit/risk assessment by the responsible veterinarian