País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Fipronil
CF Pharma Limited
QP53AX15
Fipronil
50 milligram(s)
Spot-on solution
LR: Licensed Retailer as defined in national legislation
Cats
fipronil
Ectoparasiticide
Authorised
2013-11-25
Health Products Regulatory Authority 15 January 2021 CRN008Q0M Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Parex 50 mg spot‐on solution for cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 ml pipette contains ACTIVE SUBSTANCE: Fipronil 50.00 mg EXCIPIENTS Butylhydroxyanisole (E 320) 0.10 mg Butylhydroxytoluene (E 321) 0.05 mg For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Spot‐on solution Clear, colourless to yellowish solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cat 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of cats against flea infestations (_Ctenocephalides_ spp.). Insecticidal efficacy against new infestation with fleas persists for up to 4 weeks. Although the product has not demonstrated an immediate acaricidal effect, acaricidal efficacy for up to 1 week against the tick _Ixodes ricinus_ has been shown. If ticks of _Ixodes ricinus_ are present when the product is applied, all the ticks may not be killed within the first 48 hours, but they may be killed within a week. 4.3 CONTRAINDICATIONS In the absence of available data, the veterinary medicinal product should not be used on kittens less than 8 weeks old and/or weighing less than 1 kg. Do not use on sick (systemic disease, fever, etc.) or convalescent animals. Do not use on rabbits, as adverse drug reactions and even death could occur. Do not use on animals with hypersensitivity to the active substance or any other excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The veterinary medicinal product does not prevent an infestation of the animal by ticks. For the optimal control of flea problems in households with several animals all dogs and cats should be treated with an authorised insecticide. Health Products Regulatory Authority 15 January 2021 CRN008Q0M Page 2 of 5 Fleas from pets often infest animal's baskets, bedding and regular resting areas such as carpets and soft furnishings which should be treated, in case of massive infestati Leia o documento completo