País: Hungria
Língua: inglês
Origem: HMA (Heads of Medicines Agencies)
fipronil 0.25 %
Alfamed
QP53AX15
Cutaneous spray, solution
fipronil
Cats, Dogs
2012-03-21
_ _ _ _ 1/9 UNITED KINGDOM VETERINARY MEDICINES DIRECTORATE WOODHAM LANE NEW HAW ADDLESTONE SURREY KT15 3LS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT VETFLEA 2.5 MG/ML CUTANEOUS SPRAY, SOLUTION FOR CATS AND DOGS Vetflea 2.5 mg/ml cutaneous spray, Solution for cats and dogs UK/V/0397/006/DC Alfamed Application for Decentralised Procedure Publicly Available Assessment Report 2/9 MODULE 1 PRODUCT SUMMARY EU Procedure number UK/V/0397/006/DC Name, strength and pharmaceutical form Vetflea 2.5 mg/ml cutaneous spray, Solution for cats and dogs Applicant Alfamed 13ème rue – L.I.D. 06517 Carros Cedex France Active substance(s) Fipronil ATC Vetcode QP53AX15 Target species Cats and dogs Indication for use Treatment of flea infestation (_Ctenocephalides_ spp.) in dogs and cats. Treatment of tick infestation (_Ixodes ricinus, _ _Rhipicephalus sanguineous_) in dogs and cats. Treatment of biting lice infestation in dogs (_Trichodectes _ _canis_) and cats (_Felicola _ _subrostratus_). The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). Insecticidal efficacy against new infestations with adult fleas persists for up to 6 weeks in cats and up to 3 months in dogs, depending on environmental challenge. The product has a persistent acaricidal efficacy for up to 4 weeks against ticks, depending on the level of environmental challenge. Vetflea 2.5 mg/ml cutaneous spray, Solution for cats and dogs UK/V/0397/006/DC Alfamed Application for Decentralised Procedure Publicly Available Assessm Leia o documento completo
Issued: May 2012 AN: 00106/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ALFAMED FIPRONIL (BE) / FIPROLINE (HU, RO) / VETFLEA (UK) 2.5 mg/ml cutaneous spray, Solution for cats and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains ACTIVE SUBSTANCE: Fipronil 2.5 mg EXCIPIENT: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray, solution. Clear, colourless to yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of flea infestation (_Ctenocephalides_ spp.) in dogs and cats. Treatment of tick infestation (_Ixodes ricinus, Rhipicephalus sanguineus_) in dogs and cats. Treatment of biting lice infestations in dogs (_Trichodectes canis_) and cats (_Felicola _ _subrostratus_). The product can be used as part of a treatment strategy for the control of Flea Allergy Dermatitis (FAD). Insecticidal efficacy against new infestations with adult fleas persists for up to 6 weeks in cats and up to 3 months in dogs, depending on environmental challenge. The product has a persistent acaricidal efficacy for up to 4 weeks against ticks, depending on the level of environmental challenge. 4.3 CONTRAINDICATIONS Do not use on sick (systemic diseases, fever…) or convalescent animals. Issued: May 2012 AN: 00106/2011 Page 2 of 7 Do not use in rabbits, as adverse reactions and even death could occur. Do not use in cases of hypersensitivity to the active substance or to any of excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET Leia o documento completo