FIPRON 50 MG SPOT-ON SOLUTION FOR CATS

Treatment and prevention of flea infestation (Ctenocephalides felis) and related flea allergy dermatitis (FAD) in cats. Treatment and prevention of infestation by ticks and lice in cats. 1 tube (0.5 ml) contains: Active substance: Fipronil 50 mg Excipients: Butylhydroxyanisole (E320) 0.10 mg Butylhydroxytoluene (E321) 0.05 mg Spot-on solution. Clear, yellow to yellow-green solution. Target species: Cats. Indications: Treatment and prevention of flea infestation (Ctenocephalides felis) and related flea allergy dermatitis (FAD) in cats. Treatment and prevention of infestation by ticks (Ixodes spp.) and lice (Felicola subrostratus) in cats. Contraindications: In respect of the absence of data do not apply to animals younger than 8 weeks and/or weighing less than 1 kg. Do not apply to sick animals (systemic disease, fever) and convalescent animals. Do not use in rabbits. It can cause a serious reaction or death. Do not use in case of hypersensitivity to the active substances or to any of the excipients. Special warnings for each target species: Avoid contact with animal’s eyes. With respect to a possible risk of parasite resistance to the active substance, and thus a reduced effect of therapy, the following rules of treatment with ectoparasiticides should be observed: – Avoid too frequent and recurring use of ectoparasiticides of the same group – Observe the determined dosage and dosing regimen. Administer the product in doses recommended by the manufacturer so as to ensure the optimal therapeutic effect. Special precautions for use in animals: It is important to apply the product on such a place from which the animal cannot lick it and prevent mutual licking of animals after application. Apply the product to the skin surface only. Do not administer orally or parenterally. Avoid administration of the product on the mucous membranes (eyes, nostrils, genitals and injured skin). In case of fleas, the other animals in the household should be treated with insecticides simultaneously. Bathing/shampooing of the animal is not recommended within 2 days after application, as well as bathing more frequent than once a week. Some ticks can attach after treatment, but they are killed 24-48 hours after application. This usually occurs before the tick size changes maximally, which minimizes, but does not exclude the risk of transmission of transmissible diseases. Fleas from pets often infest animal’s crates, places where the animal sleeps and resting areas, such as carpets and soft furnishings which should be treated regularly with suitable insecticides and cleaned with a vacuum cleaner in case of massive infestation and at the beginning of protective measures. Special precautions to be taken by the person administering the veterinary medicinal product to animals: People or animals with known hypersensitivity to insecticides or alcohol should avoid contact with the product. People with epilepsy should handle the product with caution. The product may cause irritation of eyes and mucous membranes. Therefore, use appropriate protective equipment and avoid contact with eyes, mucous membranes and mouth. If the product gets into the eye, flush the eye carefully with clean water. In case of serious irritation seek medical attention. This product may cause skin irritation. Do not handle treated animals and do not allow children to play with them until the applied product has dried. It is therefore recommended not to treat animals during the day, but early in the evening, and not to allow the recently treated animals to sleep with their owners, especially children. After application wash your hands with soap and water. Remove contaminated clothing which is in direct contact with the skin. Take care to avoid finger contact with the content. If this occurs, wash your hands with water and soap. In case of accidental ingestion seek medical advice immediately and show the package leaflet or label to a practitioner. Note to physician: After ingestion of a large quantity of the product the following toxicity manifestations can be expected: nausea, vomiting, headache, dizziness, abdominal pain, sweating, restlessness, weakness and tonic-clonic convulsions. The states are transient and usually resolve spontaneously. Excitation of epilepsy can occur in susceptible individuals, or at higher doses. Activated charcoal should be administered in the first step. There is no known specific antidote. Further treatment is symptomatic. Do not smoke, drink or eat during application. Adverse reactions (frequency and seriousness): Short-term hypersalivation due to the nature of vehicle may occur after licking. Transient skin reactions at the injection site (hair discolouration and loss, itching, redness) and general pruritus or alopecia were reported very rarely after use. Exceptionally, hypersalivation, reversible neurologic symptoms (hyperaesthesia, depression, nervousness), vomiting difficulty breathing were reported. Cosmetic defects (bonded hair, white deposits) may occur at the injection site. Avoid overdose. In case of persisting adverse effects seek the advice of a veterinarian. Use during pregnancy and lactation: No studies on the administration of this product to pregnant and lactating bitches are available, therefore use the product only after assessment of the benefit/risk ratio by a veterinarian. Interaction with other medicinal products and other forms of interaction: Fipronil and amitraz have a synergic effect. Amounts to be administered and administration route: For lack of data the minimum time between two applications is 4 weeks. Method of administration: spot-on use. Dosage: Apply 1 tube of 0.5 ml of the skin between the shoulder blades.