Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Fipronil; (S)-methoprene
Norbrook Laboratories (Ireland) Limited
QP53AX65
Fipronil; (S)-methoprene
67, 60.3 mg/pipette
Spot-on solution
LR: Licensed Retailer as defined in national legislation
fipronil, combinations
Authorised
2017-05-26
1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fleanil Combo 67 mg / 60.3 mg spot-on solution for small dogs (IE) Fiproclear Combo 67 mg / 60.3 mg spot-on solution for small dogs (IT, PT) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pipette of 0.67 ml contains: ACTIVE SUBSTANCES: Fipronil 67 mg (S)-methoprene 60.3 mg EXCIPIENTS: Butylhydroxyanisole (E320) .............................................................................................. 0.13 mg Butylhydroxytoluene (E321) .............................................................................................. 0.07 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. A clear, yellow solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of dogs weighing 2 to 10 kg bodyweight. To be used against infestations with fleas, alone or in association with ticks and/or biting lice. Treatment of flea infestations ( _Ctenocephalides_ spp.). Insecticidal efficacy against new infestations with adult fleas persist for 8 weeks. Prevention of the multiplication of fleas by inhibiting the development of eggs (ovicidal activity) and larvae and pupae (larvicidal activity) originating from eggs laid by adult fleas for eight weeks after application. Treatment of tick infestations ( _Ixodes_ _ricinus_ , _Dermacentor_ _variabilis, Dermacentor reticulatus_ , _Rhipicephalus_ _sanguineus_ ). The product has a persistent acaricidal efficacy for up to 4 weeks against ticks. Treatment of infestations with biting lice ( _Trichodectes canis_ ). 4.3 CONTRAINDICATIONS In the absence of available data, the product should not be used on puppies less than 8 weeks old and/or weighing less than 2 kg. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. Do not use in rabbits, as adverse reactions with even mortality could occur. In the absence of studies, the use of the product is not recommended in non-target species. This product is Läs hela dokumentet