Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Fipronil
Norbrook Laboratories (Ireland) Limited
QP53AX15
Fipronil
268 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
fipronil
Authorised
2012-07-06
Health Products Regulatory Authority 13 February 2019 CRN008TQS Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Norbrook Fipronil 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. 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 20 kg. Health Products Regulatory Authority 13 February 2019 CRN008TQS Page 2 of 8 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The product does not prevent ticks from attaching to the animals, but ticks may be killed in the first 24-48 hours after attachment prior to full engorgement and therefore minimising the r Read the complete document