Name
FIPROTEC 50 MG
Pharmacotherapeutic Group
Ectoparasiticides for topical use.
Active Ingredients
Each pipette contains: fipronil 50 mg.
Excipients
Butylhydroxyanisole (E320), Butylhydroxytoluene (E321), Benzyl alcohol (E1519), Diethylene glycol monoethyl ether.
Indications
For the treatment and prevention of flea infestations (Ctenocephalides felis) in cats. The duration of protection against flea infestations is 5 weeks. Treatment of tick infestations (Ixodes ricinus). Ticks (Ixodes ricinus) on the animal at the time of treatment will be killed within 48 hours. The treatment does not protect against new tick infestations.
Contraindications/Side Effects
In the absence of available data, the product should not be used on kittens less than 8 weeks of age and/or weighing less than 1 kg. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. Do not use on sick (systemic diseases, fever etc.) or convalescent animals. Do not use on rabbits, as adverse reactions and sometimes death may occur.
Dosage
For topical use. Apply according to the animal's body weight. 1 pipette of 50 mg per cat. Method of administration: hold the pipette upright. Tap the narrow part of the pipette to make sure the contents are within the main body of the pipette. Snap off the tip of the pipette along the scored line. Part the fur between the shoulder blades until the skin is visible. Place the tip of the pipette on the skin and squeeze gently to release one or two drops, then empty the contents onto the skin. It is important to make sure the product is applied to an area where the animal cannot lick it off and that the animal does not come into contact with other treated animals. Take care to avoid excessive wetting of the fur with the product, as this causes a sticky appearance. Should this occur, the effect disappears within 48 hours of application. For optimal control of flea and/or tick infestation, the treatment schedule can be based on the local epidemiological situation. In the absence of safety studies, the minimum treatment interval is 4 weeks.
Storage
Do not store above 25 °C. Keep the pipettes in the blister to protect them from light. Use immediately after first opening.
Warnings
For optimal control of flea infestation in multi-pet households, all dogs and cats should be treated with a suitable insecticide. Fleas often infest baskets, blankets, mattresses and carpets, which should be treated with an insecticide in case of heavy infestation and at the start of control measures; vacuum regularly. No data are available on the efficacy of the product after bathing or shampooing. For external use only. Do not apply the product to wounds or damaged skin. Avoid contact with the animal's eyes. In case of accidental contact, rinse immediately with water. Weigh animals accurately before treatment. It is important to make sure the product is applied to an area where the animal cannot lick itself. The product does not protect against tick attacks; for this reason the transmission of infectious diseases cannot be ruled out. The potential toxicity of the product for kittens under 7 months of age in case of contact with a treated cat has not been documented; take particular care in these cases. Do not use on non-target animals such as rabbits or guinea pigs. Special precautions for the person administering the product to animals: people with known hypersensitivity to fipronil or the excipients should avoid contact with the product. Avoid contact with the fingers; if this occurs, wash with soap and water. The product may cause irritation to mucous membranes and eyes. Avoid contact with the mouth and eyes. In case of accidental contact, rinse immediately with water. Ingestion of the product is harmful; keep the pipettes out of the reach of children and dispose of them immediately after application. Treated animals should not be handled until the application site is dry; do not allow children to come into contact with the animal after application. It is advisable to treat the animal in the evening and not to allow treated animals to sleep with their owners, especially children. Do not smoke, drink or eat during use. Wash hands after application. Overdose: no adverse reactions were observed after application in 12-week-old puppies, growing dogs and dogs weighing approximately 5 kg treated 3 times at 5 times the recommended dose. Incompatibilities: in the absence of compatibility studies, do not mix with other veterinary medicinal products.
Withdrawal Period
Not applicable.
Target Species
Cats.
Interactions
Do not use at the same time as other flea treatment products applied directly to the animal.
Side Effects
If the animal licks the application site, a brief period of hypersalivation may be observed, due to the excipients. Extremely rare adverse reactions include skin reactions at the application site (skin discolouration, local alopecia, itching, erythema). Exceptionally, hypersalivation, reversible neurological signs (hyperaesthesia, depression), vomiting and respiratory signs have been observed.
Pregnancy and Lactation
Laboratory studies have not shown any evidence of teratogenic or foetotoxic effects. In the absence of specific studies on use during pregnancy or lactation, use according to the benefit/risk assessment.
