Country: Portugall
Lingwa: Ingliż
Sors: HMA (Heads of Medicines Agencies)
fipronil 100 mg
Alfamed
QP53AX15
Spot-on solution
fipronil
Dogs
2012-01-31
Revised: January 2012 AN: 01618/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ALFAMED 268 mg spot-on solution for large dogs (DE: FIPROLINE, FR: TICK-PUSS, IT: PROCARE FICONTROL, UK: ECTOLINE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 2.68 ml pipette contains : ACTIVE SUBSTANCE: Fipronil 268 mg EXCIPIENTS: Butyhydroxyanisole E320 0.536 mg/pipette Butylhydroxytoluene E321 0.268 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 Dogs. 4.2 INDICATIONS FOR USE Treatment of flea (_Ctenocephalides_ spp.) and tick (_Dermacentor_ _reticulatus_) infestations. Insecticidal efficacy against new infestations with adult fleas persists for up to 8 weeks. The product has a persistent acaricidal efficacy for up to 4 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._ _ Revised: January 2012 AN: 01618/2011 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use on puppies less than 2 months old and /or weighing le Aqra d-dokument sħiħ