Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Fipronil; (S)-methopene
Vet-Agro Multi-Trade Company Sp z o.o.
QP53AX65
Fipronil; (S)-methopene
50,60 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
fipronil, combinations
Authorised
2020-03-06
Health Products Regulatory Authority 13 May 2021 CRN00C8R5 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT FIPREX DUO 50 mg+ 60 mg spot-on solution for cats and ferrets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pipette of 0.5 ml contains ACTIVE SUBSTANCES: Fipronil 50.00 mg (S)-methoprene 60.00 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.10 mg Butylhydroxytoluene (E321) 0.05 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. Clear greenish-yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and ferrets 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cats: To be used against infestations with fleas, alone or in association with ticks and/or biting lice. Elimination of fleas (_Ctenocephalides spp_.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for six weeks after application. Elimination of ticks (_Ixodes ricinus, Dermacentor variabilis, Rhipicephalus sanguineus_). The product has a persistent acaricidal efficacy for up to 2 weeks against ticks (based on experimental data). Elimination of biting lice (_Felicola subrostratus_). The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD), where this has been previously diagnosed by a veterinary surgeon. In ferrets: To be used against infestations with fleas, alone or in association with ticks. Elimination of fleas (_Ctenocephalides spp_.). Insecticidal efficacy against new infestations with adult fleas persists for 4 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity), larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas. Elimination of ticks (_Ixodes ricinus_). The product has a pers Read the complete document