AMFLEE 134 mg spot-on solution for dogs 1 pipette (1.34 ml) contains: Active substance: Fipronil 134 mg Excipients: Butylhydroxyanisole (E320) 0.27 mg Butylhydroxytoluene (E321) 0.13 mg Target species dog Indications for use, specifying target species Treatment and prevention of flea (Ctenocephalides spp), tick (Rhipicephalus spp., Dermacentor spp., Ixodes spp.) and mange lice infestations Trichodectes canis in dogs. The product has a persistent insecticidal efficacy of up to 2 months against fleas and an acaricidal efficacy of up to 4 weeks against ticks. The product can be used as part of a treatment strategy for flea allergy dermatitis (FAD), if it has been previously diagnosed by your veterinarian. Contraindications In the absence of available data, 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 (systemic diseases, fever) or in convalescent animals. Do not use in rabbits due to the risk of adverse reactions or even death. Do not use in cats as it may lead to overdose. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Special warnings for each target species Ticks present on animals must be removed before using the product to reduce the risk of transmissible diseases. It is recommended to avoid bathing or immersion in water for 2 days after applying the product and to avoid bathing more frequently than once a week, as no studies have been conducted to investigate the effectiveness of the product under these conditions. Emollient shampoos can be used before treatment, but when used weekly after application of the product, they reduce the duration of flea protection to approximately 5 weeks. Weekly bathing with medicated shampoo containing 2% chlorhexidine does not affect the effectiveness of the product against fleas, as shown in a long-term 6-week study. Sporadic ticks may occur. Thus, it is impossible to completely exclude the transmission of infectious diseases by ticks if conditions are unfavourable. Ticks will usually be killed and fall off the host within 24 - 48 hours after infestation, without feeding on the animals blood. Sporadic attachment of ticks cannot be excluded during the period of effectiveness of the product. Pet fleas often infest animal bedding, places where animals sleep and rest, such as carpets and soft furnishings, which should be regularly treated with appropriate insecticides and vacuumed in case of heavy infestations or when control measures are initiated. Special precautions for use i) Special precautions for use in animals Avoid contact of the product with the animals eyes. It is important to ensure that the product is applied in a place where the animal cannot lick it and animals should be avoided from licking each other after treatment. Dogs should not be allowed to swim in running water for 2 days after application (see section 6.6). ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals The product may cause irritation of mucous membranes and eyes. Therefore, avoid contact of the product with the mouth and eyes. People with known hypersensitivity to insecticides or alcohol should avoid contact with the veterinary medicinal product. Care should be taken to prevent fingers from coming into contact with the contents. In case of contact, wash your hands with soap and water. In case of accidental contact with eyes, rinse thoroughly with clean water. Wash hands after use. Do not touch treated animals or allow children to play with them until the application site has dried. Therefore, it is not recommended to apply the treatment during the day, but in the evening before going to bed, and treated animals should not be allowed to sleep with their owners, especially children. Do not smoke, drink or eat while applying the product. Adverse reactions (frequency and severity) If animals lick the application site, short-term hypersalivation may occur, mainly due to the nature of the excipients. After use, among the extremely rare adverse reactions, transient skin reactions at the application site (skin discoloration and local alopecia, pruritus, erythema) and generalised pruritus or alopecia may be observed. Exceptionally, hypersalivation, reversible neurological symptoms (hyperaesthesia, depression, nervous signs), respiratory signs or vomiting have been observed after use. Avoid overdose. Use during pregnancy or lactation The safety of the product has been demonstrated in breeding, pregnant and lactating females treated with multiple consecutive doses of up to 3 times the maximum recommended dose. The product can be used in breeding and pregnant females, as well as lactating females. Interactions with other medicinal products or other forms of interaction They dont know each other. Amounts to be administered and route of administration Dosage: One single-dose pipette of 1.34 ml spot-on solution per dog weighing between 10 kg and 20 kg bodyweight. This ensures a minimum recommended dose of fipronil of 6.7 mg/kg body weight. In the absence of product safety studies, the minimum interval between treatments is 4 weeks. Monthly treatment is recommended in cases where there is a high risk of repeated flea infestations, where dogs are allergic to flea bites and where tick infestation control is necessary, or where frequent bathing with hypoallergenic or emollient shampoos is used. In areas where there is no high risk of flea and tick infestations, the product can be applied once every two to three months. Route of administration: External application to the skin (spot-on use). Method of administration: Remove the single-dose pipette from the triplex pouch. Hold the single-dose pipette upright, twist and pull off the cap. Turn the cap over and place the other end of the cap onto the single-dose pipette. Push and twist the cap to pierce the seal, then remove the cap from the single-dose pipette. Remove the animal’s hair from the area between the shoulders to make the skin visible. Place the tip of the single-dose pipette on the skin and press the pipette several times to empty the contents directly onto the skin in one spot. Overdose (symptoms, emergency procedures, antidotes), as appropriate Laboratory studies on the safety of the product in the target animal species, carried out in puppies aged 8 weeks, growing dogs with a body weight of around 2 kg, treated once with doses 5 times the recommended dose, demonstrated no adverse reactions. However, the risk of adverse reactions (see section 4.6) may increase with overdose, therefore animals should always be treated with the correct pipette size according to body weight. Waiting time Thats not the case. Pharmacodynamic properties Fipronil is an insecticide/acaricide of the phenylpyrazole group. It acts on arthropods by interacting with ligands of chloride ion channels, in particular those regulated by the neurotransmitter gamma-aminobutyric acid (GABA), thus blocking the pre- and postsynaptic transport of chloride ions across cell membranes. This leads to uncontrolled activity of the central nervous system and the death of insects and mites. The product contains the active ingredient fipronil, which has a unique mechanism of action against fleas and ticks. Amflee spot-on solution accumulates in the lipid component of the skin and hair follicles and is continuously eliminated from the follicles on the skin and hair, thus ensuring a persistent long-term activity. Pharmacokinetic features Following topical application of the product to dogs, fipronil is poorly absorbed through the skin (approximately 15%). Variable concentrations of fipronil in blood plasma have been observed in dogs. After application of the product, a gradient of fipronil concentration is found on the animals fur, extending from the point of application towards peripheral areas (lumbar areas, flanks). In dogs, fipronil is metabolized to the sulfonic derivative (RM 1602), which also exerts insecticidal and acaricidal effects. In dogs, the concentration of fipronil in the hair decreases over time and reaches a level of approximately 3 - 4 µg/g after 56 days of treatment. List of excipients Butylated hydroxytoluene (E321) Butylated hydroxyanisole (E320) Ethanol 96% Polysorbate 80 Povidone K25 Diethylene glycol monoethyl ether incompatibility They dont know each other. Validity period Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Special precautions for storage Store in the original packaging, protected from light. This veterinary medicinal product does not require any special temperature storage conditions. 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, information about the manufacturer 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: 10-20 kg Pieces Set: 1 piece n Quantity: 1 Pipette