Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
fipronil 10 mg
Virbac S.A.
QP53AX15
Spot-on solution
fipronil
Cats
2011-02-09
Revised: September 2011 AN: 00356/2011 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT EFFIPRO 50 mg spot-on solution for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 0.5 ml pipette contains: ACTIVE SUBSTANCE: Fipronil 50 mg EXCIPIENTS: Butylhydroxyanisole E320 0.1 mg/pipette Butylhydroxytoluene E321 0.05 mg/pipette For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spot-on solution. Clear, colourless to yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE Treatment of flea (_Ctenocephalides_ spp.) and tick (_Dermacentor reticulatus_) infestations. The product has a persistent insecticidal efficacy for up to 5 weeks against fleas (_Ctenocephalides_ _felis_). The product has a persistent acaricidal efficacy for up to 2 weeks against ticks (_Rhipicephalus sanguineus, Ixodes ricinus,_ _Dermacentor reticulatus_). If ticks of some species (_Rhipicephalus sanguineus_ and _Ixodes ricinus_) 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. 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 In the absence of available data, the product should not be used on kittens less than 2 months old and/or weighing less than 1 kg. Revised: September 2011 AN: 00356/2011 Page 2 of 8 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 Read the complete document