Land: Storbritannia
Språk: engelsk
Kilde: VMD (Veterinary Medicines Directorate)
Fipronil
Krka d.d., Novo Mesto
QP53AX15
Fipronil
Spot-on solution
NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person
Cats
Ectoparasiticide
Expired
2012-09-20
Revised: May 2017 AN: 00882/2016 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fyperix 50 mg spot-on solution for cats Fyperix vet 50 mg spot-on solution for cats Fyperix 50 mg spot-on solution for cats (United Kingdom, France, Germany, Portugal, Spain, Netherlands, Italy) Fyperix vet 50 mg spot-on solution for cats (Denmark, Finland, Sweden, Norway) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 50 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. Light yellow to yellow, clear liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of fleas (_Ctenocephalides_ spp.) and tick (_Ixodes ricinus_)_ _infestations in cats. The product has a persistent insecticidal efficacy for up to 4 weeks against fleas (_Ctenocephalides_ spp.) and acaricidal efficacy for up to 4 weeks against _Ixodes _ _ricinus_ and for up to 1 week against _Dermacentor reticulatus _and _Rhipicephalus _ _sanguineus_. If ticks of some species (_Dermacentor reticulatus _and _Rhipicephalus _ _sanguineus_) are present when the product is applied, all the ticks may not be killed within the first 48 hours but they may be killed within a week. 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. Revised: May 2017 AN: 00882/2016 Page 2 of 6 4.3 CONTRAINDICATIONS In the absence of available data, the product should not be used on kittens less than 2 months old and/or weighing less than 1 kg. Do not use on sick (e.g. systemic diseases, fever…) or convalescent animals. Do not use in rabbits, as adverse reactions and even death could occur. Do not use in known cases of hypersensitivity to fipronil, dimethyl sulphoxide or to any of the excipients. 4.4 SPECIAL W Les hele dokumentet