Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Fipronil
Chanelle Pharmaceuticals Manufacturing Limited
QP53AX15
Fipronil
268 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
fipronil
Ectoparasiticide
Authorised
2012-07-13
Health Products Regulatory Authority 21 August 2018 CRN000YZ5 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Zeronil 268 mg Spot-on Solution for large dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One 2.68 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 268 mg EXCIPIENTS: Butylhydroxyanisole E320 0.536 mg Butylhydroxytoluene E321 0.268 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. Clear, pale amber solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea (_Ctenocephalides _spp.) and tick (_Rhipicephalus sanguineus _and _Ixodes ricinus_) infestations. Insecticidal efficacy against new infestations with adult fleas persists for 2 months. The product has a persistent acaricidal efficacy for 1 month against ticks (_Rhipicephalus sanguineus_, _Ixodes ricinus_, _Dermacentor reticulatus_). For _Ixodes ricinus _ and _Rhipicephalus sanguineus_, ticks will normally be killed within the first 48 hours following first application of the product. For established infestations of _Dermacentor_ _reticulatus_, an immediate acaricidal effect has not been demonstrated. However, ticks will normally be killed within a week following first application of the product. 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. Health Products Regulatory Authority 21 August 2018 CRN000YZ5 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use on puppies less than 2 months old or puppies or dogs weighing less than 2kg. 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 or to any of excipients. 4.4 SPECIAL WARNINGS Lesen Sie das vollständige Dokument