国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Fipronil
Krka, d.d., Novo mesto
QP53AX15
Fipronil
67 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
fipronil
Ectoparasiticide
Authorised
2011-11-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Eliminall 67 mg spot-on solution for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pipette (0.67 ml) 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. Light yellow to yellow, clear liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 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. 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 specifically developed for dogs. Do not use in cats, as this could lead to overdosing. Do not use in cases of hypersensitivity to the active substance, dimethyl sulphoxide or to any of other excipients. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ 阅读完整的文件