1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing Authorisation Holder: Vet-Agro Multi Trade Company Sp. z oo, ul.Gliniana 32, 20-616 Lublin, Tel:+48 81 445 23 00, Fax: +48 81 445 23 20, e-mail vet-agro@vet-aizro.pl Manufacturer responsible for batch release: Vet-Agro Multi Trade Company Sp. z oo, ul. Melgiewska 18, 20-234 Lublin. 2. NAME OF THE VETERINARY MEDICINAL PRODUCT FIPREX DUO XL 402 mg + 361.8 mg spot-on solution for dogs Fipronil/(S)-methoprene 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 4.02 ml pipette contains: Active substances: Fipronil 402.00 mg (S)-methoprene 361.80 mg Excipients: Butylhydroxyanisole (E320) 0.80 mg Butylhydroxytoluene (E321) 0.40 mg Clear, greenish-yellow solution. 4. INDICATION(S) For the treatment of dogs with a body weight of over 40 kg. For use against flea infestations or mixed infestations with ticks and/or malophagous lice. • Treatment of flea infestations (Ctenocephalides spp.). Insecticidal efficacy against new infestations of adult fleas is 8 weeks. Prevention of flea multiplication by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity), which originate from eggs laid by adult fleas, persists for eight weeks after application of the product. • Treatment of tick infestations (Ixodes ricinus, Dermacentor variabilis, Dermacentor relictilla, Rhipicephalus sanguineus). The product has a persistent acaricidal efficacy for up to 4 weeks against ticks. • Treatment of infestations with mange lice (Trichodectes canis). The product can be used as part of a treatment strategy to combat flea allergy dermatitis (FAD) where it has been previously diagnosed by a veterinarian. 5. CONTRAINDICATIONS In the absence of available data, the product should not be used in puppies less than 8 weeks of age. Do not use in sick animals (e.g. systemic diseases, fever) or convalescent animals. Do not use in rabbits as adverse reactions or even mortality may occur. In the absence of studies, the use of the product is only recommended for the target species. This product is specifically developed for dogs. Do not use in cats and ferrets as it could lead to overdose. Do not use in cases of hypersensitivity to the active substance or any of the excipients. 6. ADVERSE REACTIONS Among the very rare suspected adverse reactions, transient skin reactions at the application site (skin discoloration, localized hair loss, itching, redness) and generalized itching or hair loss have been reported after use. Excessive salivation, reversible nervous signs (increased sensitivity to stimulation, depression, other nervous signs), vomiting or respiratory symptoms have been observed after use. 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). If animals lick themselves, a brief period of excessive salivation may be observed mainly due to the nature of the excipients. Do not overdose. If you notice any adverse reactions, even those not already included in this leaflet or you think that the medicine has not had any effect, please inform your veterinarian. Alternatively, you can report through the national reporting system {famiacovigilenta@icbmv.ro}. 7. TARGET SPECIES Dogs (>40 kg). 8. DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION Route of administration and dosage: Spot-on administration. One pipette of 4.02 ml/dog with a body weight of over 40 kg, corresponding to the minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)-methoprene by topical application to the skin. In the absence of safety studies, the minimum interval between treatments is 4 weeks. Method of administration: Hold the pipette upright. Press the narrow part of the pipette to ensure that all the contents remain in the main body of the pipette. Pull back the tip. Make a path in the fur on the animal’s back at the base of the neck in front of the shoulder blade, until the skin is visible. Place the tip of the pipette on the skin and squeeze the pipette several times to empty its contents completely and directly onto the skin, in one spot. Temporary changes in the coat (greasy/clumped hair) may be observed at the application site. 9. RECOMMENDATIONS ON CORRECT ADMINISTRATION It doesnt exist. 10. WAITING TIME(S) Thats not the case. 11. SPECIAL STORAGE PRECAUTIONS Keep out of sight and reach of children. Store in the original package in order to protect from light and moisture. Store below 25°C. Do not use this veterinary medicinal product after the expiry date which is stated on the carton and pipette after EXP. 12. SPECIAL WARNING(S) Special precautions for each target species: Bathing/immersion in water within 2 days of application of the product and bathing more frequently than once a week should be avoided as no study has been conducted to investigate how this affects the efficacy of the product. Emollient shampoos can be used prior to treatment but reduce the duration of flea protection to approximately 5 weeks when used weekly after application of the product. Weekly bathing with a medicated shampoo containing 2% chlorhexidine did not affect the efficacy of the product against fleas during a long-term, 6-week study. Dogs should not be allowed to swim in watercourses for 2 days after application. Attachment of single ticks may be present. For this reason, transmission of infectious diseases cannot be completely ruled out if conditions are unfavorable. Fleas on pets often infest the basket, bedding and resting areas regularly frequented by animals, such as carpets and interior decorations which should be treated, in case of massive infestations and when initiating control measures, with an appropriate insecticide and vacuumed regularly. Other animals living in the same household should also be treated with an appropriate product. Special precautions for use in animals: Avoid contact of the product with the eyes of animals. Do not apply the product to damaged skin or wounds. It is important to ensure that the product is applied to an area where the animal cannot lick it and animals should be avoided from licking each other after treatment. 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 veterinary medicinal product. Avoid contact of the contents with fingers. In case of accidental contact, wash hands with soap and water. In case of accidental contact with eyes, rinse eyes thoroughly and immediately with clean water. After use, wash your hands. Ingestion of the product may be harmful. Keep pipettes out of reach of children and throw away used pipettes immediately after application of the product. In case of accidental ingestion of the product, seek medical advice immediately. 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 not be treated during the day but should be treated in the early evening and recently treated animals should not be allowed to sleep with their owners, especially children. During application, do not smoke, drink or eat. Solvent alcohol can have adverse effects on painted surfaces or lacquered furniture or other finished surfaces. Pregnancy and lactation: The product can be used during pregnancy and lactation. Interactions with other medicinal products and other forms of interaction: They dont know each other. Overdose (symptoms, emergency procedures, antidote): No adverse reactions were observed in safety studies in target animals, 8-week-old puppies, growing dogs and dogs weighing approximately 2 kg treated once with a dose five times the recommended dose. The risk of adverse reactions may increase with overdose (see section 4.8), animals should always be treated with the correct pipette size according to body weight. Incompatibilities: Thats not the case. 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Medicines should not be thrown away in wastewater or household waste. Ask your veterinarian for information on how to dispose of medicines no longer required. These measures help protect the environment. 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED15. OTHER INFORMATION Packaging dimensions: 1 pipette x 4.02 ml in a cardboard box. Product compliance information Product compliance information Product safety Manufacturer information Personal information Product safety information Currently, product safety information is not available. Manufacturer information Currently, manufacturer information is not available. Responsible person information Currently, information about the person responsible is not available. n Presentation type: Pipette Action: Ticks, Fleas, Lice Dog Weight: 40-60 kg Pieces Set: 1 piece n Quantity: 1 Pipette