Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Fipronil; (S)-methoprene
Chanelle Pharmaceuticals Manufacturing Limited
QP53AX65
Fipronil; (S)-methoprene
50, 60 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Cats, Ferrets
fipronil, combinations
Ectoparasiticide
Authorised
2018-04-20
Health Products Regulatory Authority 06 November 2020 CRN009YGJ Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Zeronil Combo 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 amber 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). 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 persistent acaricidal efficacy for 4 weeks against ticks (based on experimental Læs hele dokumentet