国家: 英国
语言: 英文
来源: 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
2011-11-15
Revised: March 2017 AN: 01807/2015 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Eliminall 402 mg spot-on solution for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pipette (4.02 ml) contains: ACTIVE SUBSTANCE: Fipronil 402 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.80 mg Butylhydroxytoluene (E321) 0.40 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. Revised: March 2017 AN: 01807/2015 Page 2 of 6 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Bathing/immersion in water within 阅读完整的文件