Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Fipronil ; (S)-methoprene
Norbrook Laboratories Limited
QP53AX65
Fipronil ; (S)-methoprene
268/241.2 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
fipronil, combinations
Ectoparasiticide
Authorised
2017-05-12
Health Products Regulatory Authority 22 January 2018 CRN000WT2 Page 1 of 8 1 NAME OF THE VETERINARY MEDICINAL PRODUCT PestiGon Combo 268 mg / 241.2 mg spot-on solution for large dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pipette of 2.68 ml contains: ACTIVE SUBSTANCES: Fipronil 268 mg (S)-methoprene 241.2 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.54 mg Butylhydroxytoluene (E321) 0.27 m 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 20 to 40 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 persists 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 persistent acaricidal efficacy for up to 4 weeks against ticks. Treatment of infestations with biting lice _(Trichodectes canis)._ Health Products Regulatory Authority 22 January 2018 CRN000WT2 Page 2 of 8 The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). 4.3 CONTRAINDICATIONS In the absence of available data, the product should not be used on puppies less than 8 weeks old. Do not use in rabbits, as adverse reactions with even mortality could occur.In absence of studies, the use of the product is not recommended in non-target species. Do not use on sick (e.g. systemic diseases, fever) or convalescent animals. This product is specifically developed for dogs. Do not use in cats and ferrets, Soma hati kamili