Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Fipronil
Norbrook Laboratories Limited
QP53AX15
Fipronil
67 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
fipronil
Ectoparasiticide
Authorised
2012-07-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norbrook Fipronil 67 mg Spot-On Solution for Small Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.67 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 67 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.134 mg Butylhydroxytoluene (E321) 0.067 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. A clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infestations by fleas (Ctenocephalides felis). The product shows immediate insecticidal effect and persistent insecticidal activity against new infestations by adult fleas for up to 8 weeks. The product has a persistent acaricidal efficacy against Ixodes ricinus for up to 2 weeks, Rhipicephalus sanguineus for up to 3 weeks and Dermacentor reticulatus for up to 4 weeks. If ticks of these species are present when the product is applied, all ticks will not be killed within the first 48 hours but they may be killed within a week. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _5_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _4_ _8_ _4_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.3 CONTRAINDICATIONS Do not use in dogs weighing less than 2 kg. In the absence of available data, the product should not be used in puppies less than 8 weeks old. Do not use in sick (systemic diseases, Lees het volledige document