Land: Rumänien
Sprache: Englisch
Quelle: HMA (Heads of Medicines Agencies)
fipronil 10 %
Alfamed
QP53AX15
Spot-on solution
fipronil
Dogs
2012-03-21
Vetflea 67 mg Spot-On Solution for Small Dogs UK/V/0397/002/DC Vetflea 134 mg Spot-On Solution for Medium Dogs UK/V/0397/003/DC Vetflea 268 mg Spot-On Solution for Large Dogs UK/V/0397/004/DC Vetflea 402 mg Spot-On Solution for Very Large Dogs UK/V/0397/005/DC Alfamed Application for Decentralised Publicly Available Assessment Report 1/16 UNITED KINGDOM VETERINARY MEDICINES DIRECTORATE WOODHAM LANE NEW HAW ADDLESTONE SURREY KT15 3LS MUTUAL RECOGNITION PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT VETFLEA 67 MG SPOT-ON SOLUTION FOR SMALL DOGS VETFLEA 134 MG SPOT-ON SOLUTION FOR MEDIUM DOGS VETFLEA 268 MG SPOT-ON SOLUTION FOR LARGE DOGS VETFLEA 402 MG SPOT-ON SOLUTION FOR VERY LARGE DOGS Vetflea 67 mg Spot-On Solution for Small Dogs UK/V/0397/002/DC Vetflea 134 mg Spot-On Solution for Medium Dogs UK/V/0397/003/DC Vetflea 268 mg Spot-On Solution for Large Dogs UK/V/0397/004/DC Vetflea 402 mg Spot-On Solution for Very Large Dogs UK/V/0397/005/DC Alfamed Application for Decentralised Publicly Available Assessment Report 2/16 MODULE 1 PRODUCT SUMMARY EU Procedure number UK/V/0397/002/DC UK/V/0397/003/DC UK/V/0397/004/DC UK/V/0397/005/DC Name, strength and pharmaceutical form Vetflea 67 mg Spot-On Solution for Small Dogs UK/V/0397/002/DC Vetflea 134 mg Spot-On Solution for Medium Dogs Vetflea 268 mg Spot-On Solution for Large Dogs Vetflea 402 mg Spot-On Solution for Very Large Dogs Applicant ALFAMED 13ème Rue – L.I.D. 06517 CARROS CEDEX FRANCE Active substance Fipronil ATC Vetcode QP53AX15 Target species Dogs Indications Lesen Sie das vollständige Dokument
Issued: August 2012 AN: 00105/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ALFAMED FIPRONIL (BE) / FIPROLINE (HU, RO) / VETFLEA (UK) 402 mg Spot-on solution for very large dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 4.02 ml pipette contains : ACTIVE SUBSTANCE: Fipronil 402 mg EXCIPIENTS: Butyhydroxyanisole E320 0.804 mg Butylhydroxytoluene E321 0.402 mg 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. _ _ Issued: August 2012 AN: 00105/2011 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use on puppies less than 2 months old and /or weighing less than 2kg in the absence of available data. Do not use on sick Lesen Sie das vollständige Dokument