Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Fipronil
Vetoquinol UK Limited
QP53AX15
Fipronil
67 mg/pipette
Spot-on solution
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
fipronil
Ectoparasiticide
Authorised
2011-09-30
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flevox 67 mg spot-on solution for small dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 pipette of 0.67 ml contains: ACTIVE SUBSTANCE: Fipronil 67 mg EXCIPIENTS: Butylhydroxyanisole (E320) 0.268 mg Butylhydroxytoluene (E321) 0.134 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Spot-on solution Limpid, yellow solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: Treatment of flea (_Ctenocephalides_ spp.) and biting/chewing lice (_Trichodectes canis)_ infestations in dogs. Insecticidal efficacy against new infestations with adult fleas persists for up to 8 weeks. Newly arriving fleas are killed within 48 hours of landing on the animal. 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. The product has not demonstrated an immediate acaricidal effect against ticks but has demonstrated persistent acaricidal efficacy for up to 4 weeks against_ Rhipicephalus sanguineus_ and_ Dermacentor reticulatus_ and up to 3 weeks against_ Ixodes Ricinus._ If ticks of these species are present when the product is applied, all the ticks may not be killed within the first 48 hours but they may be killed within a week. 4.3 CONTRAINDICATIONS Do not use on puppies less than 8 weeks old and/or weighing less than 2 kg in the absence of available data. Do not use on sick (systemic diseases, fever…) or convalescent animals. Do not use in rabbits, as adverse drug reactions and even death could occur. Do not use in case of hypersensitivity to fipronil or to any of the excipients. Do not administer orally. This product has been developed specifically for dogs. Do not use on cats as this could lead to overdosing. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Lire le document complet