Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FIPRONIL
Norbrook Laboratories Limited
QP53AX15
FIPRONIL
134 Milligram
Spot On Solution
POM
Canine
Fipronil
Ectoparasiticide
Authorised
2012-07-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norbrook Fipronil 134 mg Spot-On Solution for Medium Dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One 1.34 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 134 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.268 mg Butylhydroxytoluene (E321) 0.134 mg For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution. A clear, colourless to pale yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infestations by fleas (_Ctenocephalides felis_). The product shows immediate insecticidal effect and persistent insecticidal activity against new infestations by adult fleas for up to 8 weeks. The product has a persistent acaricidal efficacy against _Ixodes ricinus _for up to 2 weeks, _Rhipicephalus sanguineus _for up to 3 weeks and _Dermacentor reticulatus _for up to 4 weeks. If ticks of these species are present when the product is applied, all ticks will not be killed within the first 48 hours but they may be killed within a week. 4.3 CONTRAINDICATIONS Do not use in dogs weighing less than 10 kg. In the absence of available data, the product should not be used in puppies less than 8 weeks old. Do not use in sick (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 known hypersensitivity to the active or to any of the excipients. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/10/2013_ _CRN 7015899_ _page numbe Read the complete document