Ikigo cy’Igihugu gishinzwe kugenzura ibiribwa n’imiti cyahagaritse umuti witwa Flucazol ukorerwa mu gihugu cy’ Ubuhinde
Ikigo cy’Igihugu gishinzwe Kugenzura ibiribwa n’Imiti (Rwanda FDA) cyahagaritse gukwirakwiza no gukoresha nimero AD220070A y’umuti witwa “Flucazol® Powder for Oral Suspension (Fluconazole USP 50mg/5m1)”, ukorwa n’uruganda rwitwa Gracure Pharmaceuticals “Limited rwo mu Gihugu cy’u Buhinde ndetse utangaza ko utemerewe gukomeza kuwukoresha.
Mu itangazo cyashyize ahagaragara, iki kigo cyasabye abafite ububiko bw’imiti, abinjiza imiti mu Rwanda, farumasi ziranguza n’izidandaza, amavuriro ya Leta n’ayigenga, abaganga n’abahanga mu by’imiti n’abakoresha imiti bose ko wari witezwe kuzarangira muri Nzeri 2025, ariko ukaba wahagaritswe ku bushake bw’uruganda rwawukoze.
Iki kigo cyatangaje ko ingano iri mu gacupa idahura neza n’ibipimo byagenwe aho bigira ingaruka mugutuma udashonga uko bikwiye, bityo bikaba bishobora guteza gukoresha ibipimo bitaribyo.
Amakuru avuga ko hagendewe ku nyandiko yo ku itariki ya 14 Ugushyingo 2024 y’ikigo EXPHAR s.a. cyo mu Bubiligi, gifite uruhushya rwo gushyira ku isoko uwo muti, kugira ngo uhagarikwe nyuma yo gusuzuma byimbitse ibipimo byawo.
Abafite uwo muti basabwe guhagarika kuwutanga cyangwa kuwukoresha, bagasubiza iyo nomero y’umuti wakuwe ku isoko aho waguriwe no kuwushyikiriza Rwanda FDA mu gihe cy’iminsi 10 y’akazi ni ukuvuga uhereye uyu munsi, raporo igizwe n’imibare y’ingano y’uwo muti baranguye, iyo bagurishije, iyagaruwe ndetse n’ingano yose bazaba bafite igomba kwangizwa (iyagaruwe wongeyeho itaracurujwe).
Nanone Kandi Umuntu waba agifite umuti wa Flucazol® Powder for Oral Suspension (Fluconazole USP 50mg/5m1) ufite nimero AD220070A arasabwa guhagarika kuwukoresha akihutira kuwusubiza kuri farumasi bakawusimbuza undi bifite umumaro umwe uwo ugashyikirizwa Rwanda FDA.
Prof. Emile Biennvenue, akaba n’umuyobozi mukuru wa Rwanda FDA ,yasabye abaturage kwita ku miti bahabwa bakanabanza gushishoza cyane kuyo bakura muri za farumasi, yibukije Kandi ko abakeneye ibindi bisobanuro, gutanga amakuru ajyanye n’ubuziranenge bw’imiti bukemangwa cyangwa ingaruka ku miti bahamagara kuri nomero itishyurwa ya 9707 cyangwa 0788771663, cyangwa bakohereza ubutumwa kuri imeri pv_sm@rwandafda.gov.rw.bafashwa mu buryo bushoboka.
Uyu muti witwa “Flucazol® Powder for Oral Suspension (Fluconazole USP 50mg/5m1)”, usanzwe wifashishwa mu kuvura uburwayi buterwa n’akanyabuzima kitwa fungi gashobora gufata mu rwungano ngogozi, ndetse no mu rwungano rw’inkari.
