PestiGon Combo Dog S 67 mg / 60.3 mg, 3 pipettes is a spot-on solution for small dogs containing Fipronil, S-methoprene. One 0.67 ml pipette contains: Active substances: Fipronil 67 mg (S)-methoprene 60.3 mg Excipients: Butylhydroxyanisole (E320) 0.13 mg Butylhydroxytoluene (E321) 0.07 mg A clear, yellow solution. Directions For the treatment of dogs with a body weight of 2 kg to 10 kg. The product is used for the treatment of flea, tick and lice infestations in dogs. In the treatment of dogs with the product: Elimination of fleas (Ctenocephalides spp.) and prevention of new infestations with adult fleas for up to 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. Elimination of ticks (Ixodes ricinus, Dermacentor variabilis, Dermacentor reticulatus, Rhipicephalus sanguineus) Elimination of mange lice (Trichodectes canis) The product can be used as part of a treatment strategy to combat flea allergy dermatitis (FAD). CONTRAINDICATIONS The product should not be used in puppies less than 8 weeks of age and/or weighing less than 2 kg. 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 in the target species. This product is specifically developed for dogs. It is not for use in cats and domestic ferrets as it could lead to an overdose. Do not use in cases of hypersensitivity to the active substance or any of the excipients. 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) or vomiting have been observed after use. The frequency of adverse reactions is defined using the following convention: 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 side effects, even those not already included in this leaflet, or you think that the medicine has not had any effect, please inform your veterinarian. TARGET SPECIES: Dogs. ADMINISTRATION AND METHOD OF ADMINISTRATION Dosage: One pipette of 0.67 ml/dog with a body weight of over 2 kg and up to 10 kg, corresponding to the minimum recommended dose of 6.7 mg/kg for fipronil and 6 mg/kg for (S)-methoprene. Route of administration: for external use only, spot-on application. The pipette is removed from the bag only before use. Method of administration: Remove the pipette from the pouch, using scissors or by folding along the diagonal line to expose the notches; pull back to break the notches. 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. Rotate and pull back the tip. Make a path in the fur on the animals 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. RECOMMENDATIONS ON CORRECT ADMINISTRATION Animals should be weighed accurately before treatment. 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. Bathing/immersion in water within 2 days of product application and bathing more frequently than once a week should be avoided as no studies have 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 product application. 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. The minimum interval between treatments is 4 weeks. WAITING TIME: Not applicable. SPECIAL STORAGE PRECAUTIONS Keep out of sight and reach of children. Store in the original packaging in order to protect from light and moisture. This veterinary medicinal product does not require any special temperature storage conditions. Do not use this veterinary medicinal product after the expiry date which is stated on the sachet and carton. SPECIAL WARNINGS For veterinary use only. 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. Dogs should not be allowed to swim in watercourses for 2 days after application. Special precautions for use in animals Avoid contact of the product with the eyes of animals. Special precautions to be taken by the person administering the veterinary medicinal product to animals This product may cause irritation of the mucous membranes, skin and eyes. Therefore, contact of the product with the mouth, skin and eyes should be avoided. In case of accidental contact with the eyes, rinse the eyes thoroughly and immediately with clean water. If irritation persists, seek medical advice and show the package leaflet or the label to the doctor. In case of accidental contact with the skin, wash hands with soap and water. People with known hypersensitivity to insecticides or alcohol should avoid contact with the veterinary medicinal product. After use, wash your hands. Ingestion of the product is 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. Gestation and lactation The product can be used during pregnancy and lactation. Overdose (symptoms/emergency procedures, antidotes) 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, animals should always be treated with the correct pipette size according to body weight. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from the use of such products should be disposed of in accordance with local requirements. Fipronil and (S)-methoprene may be harmful to aquatic organisms. Do not contaminate lakes, streams and drains with the product or empty bottles. 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: 2-10 kg Pieces Set: 3 pieces Product Code: 6422966112032 n Quantity: 3 Pipettes