Country: United Kingdom
Language: English
Source: 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
Dogs
Ectoparasiticide
Expired
2012-09-19
Revised: May 2017 AN: 00885/2016 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Fyperix 134 mg spot-on solution for dogs Fyperix vet 134 mg spot-on solution for dogs Fyperix 134 mg spot-on solution for dogs (United Kingdom, France, Germany, Portugal, Spain, Netherlands, Italy) Fyperix vet 134 mg spot-on solution for dogs (Denmark, Finland, Sweden, Norway) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pipette (1.34 ml) contains: ACTIVE SUBSTANCE: Fipronil 134 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.268 mg Butylhydroxytoluene (E321) 0.134 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 Dogs (weighing over 10 kg, up to a maximum of 20 kg) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea (_Ctenocephalides_ spp.) and tick (_Dermacentor reticulatus_)_ _ infestations. For treatment of _Trichodectes canis_ biting lice infestations on dogs. Most lice are killed within 2 days. Insecticidal efficacy against new infestations with adult fleas persists for up to 8 weeks. The product has a persistent acaricidal efficacy for up to 3 weeks against _Ixodes _ _ricinus_ and up to 4 weeks against _Rhipicephalus_ _sanguineus_ and_ Dermacentor _ _reticulatus_. If ticks of some species (_Ixodes ricinus, Rhipicephalus_ _sanguineus_) are present when the product is applied, all the ticks may not be killed within the first 48 hours. 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: 00885/2016 Page 2 of 6 4.3 CONTRAINDICATIONS Do not use on puppies less than 2 months old and/or weighing less than 2 kg in the absence of available data. 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. This product is specif Read the complete document