Gusobanura Itangazo ku cyiciro cyo gucunga ibicuruzwa bya Sodium hyaluronate yubuvuzi (No 103, 2022)

Vuba aha, Ikigo cya Leta gishinzwe ibiribwa n’ibiyobyabwenge cyasohoye Itangazo ku cyiciro cy’imicungire y’ibicuruzwa bya sodium hyaluronate y’ubuvuzi (No 103 mu 2022, nyuma yiswe No 103 Itangazo).Amavu n'amavuko y'ingenzi yo gusubiramo Itangazo No 103 ni aya akurikira:

I. Amavu n'amavuko yo gusubiramo

Mu mwaka wa 2009, icyahoze ari ikigo cya Leta gishinzwe ibiribwa n’ibiyobyabwenge cyasohoye Itangazo ku cyiciro cy’imicungire y’ibicuruzwa bya Sodium hyaluronate y’ubuvuzi (No 81 yo mu 2009, nyuma yiswe Noteri No 81) kugira ngo biyobore kandi bigenzure iyandikwa n’ubugenzuzi bwa sodium hyaluronate () sodium hyaluronate) ibicuruzwa bifitanye isano.Hamwe niterambere ryihuse ryikoranabuhanga ninganda no kugaragara kwibicuruzwa bishya, Itangazo 81 ntirishobora kongera guhaza ibyifuzo byinganda n’amabwiriza.Kubera iyo mpamvu, Ikigo cya Leta gishinzwe ibiribwa n’ibiyobyabwenge cyateguye ivugurura ry’itangazo rya 81.

Ii.Kuvugurura ibyingenzi

. .Mu rwego rwo kuyobora neza kugena ibiranga imiyoborere n'ibyiciro by'ibicuruzwa bifitanye isano, Itangazo No 103 ryongeyeho ihame ryo gusobanura ibiranga imiyoborere y'ibicuruzwa byo mu bwoko bwa farumasi n'ibikoresho bivura imiti birimo sodium hyaluronate (sodium hyaluronate) hamwe n'ihame ry'ibikoresho by’ubuvuzi bijyanye , kandi asobanura ibiranga imiyoborere nicyiciro cyibicuruzwa bifitanye isano.

.Ubu bwoko bwibicuruzwa ntibyemewe hakurikijwe ibihe byo gucuruza ibiyobyabwenge, kugirango bikomeze imiyoborere, komeza kugumana imiterere yambere yubuyobozi.

. bizakoreshwa nkigikoresho cyubuvuzi cyo mu cyiciro cya III;Niba ibicuruzwa birimo anesthetike yaho hamwe nindi miti (nka lidocaine hydrochloride, aside amine, vitamine), bifatwa nkibicuruzwa bivura bishingiye ku bikoresho bivura.

. gutangwa ukurikije ubwoko bwa gatatu bwibikoresho byubuvuzi;Niba ibicuruzwa birimo anesthetike yaho hamwe nibindi biyobyabwenge (nka lidocaine hydrochloride, aside amine, vitamine, nibindi), bifatwa nkibicuruzwa bivura bishingiye ku bikoresho bivura.

.Nyamara, hamwe niterambere ryubumenyi nikoranabuhanga hamwe no kurushaho gusobanukirwa sodium hyaluronate, abantu benshi bizera mubushakashatsi bwubumenyi bwa siyansi ko iyo sodium hyaluronate ikoreshwa mukwambara kwa muganga, uburemere bwa molekile nyinshi sodium hyaluronate ikoreshwa mubikomere byuruhu bishobora kwizirika hejuru y'ibikomere by'uruhu kandi bikurura umubare munini w'amazi ya molekile.Gutanga ibidukikije bikiza hejuru y igikomere, kugirango byorohereze gukira hejuru y igikomere, ihame ryibikorwa byaryo ni umubiri.Ibicuruzwa bigengwa nkibikoresho byubuvuzi muri Amerika no mu muryango w’ubumwe bw’ibihugu by’Uburayi.Kubwibyo, imyambarire yubuvuzi ivugwa muri Bulletin 103 irimo sodium hyaluronate igenwa nkibikoresho byubuvuzi niba bidafite ibikoresho bya farumasi bifite ingaruka za farumasi, metabolike cyangwa immunologiya;Niba ishobora kwinjizwa igice cyangwa rwose umubiri cyangwa igakoreshwa mubikomere bidakira, igomba gucungwa ukurikije ubwoko bwa gatatu bwibikoresho byubuvuzi.Niba idashobora kwinjizwa numubiri kandi ikoreshwa mubikomere bidakira, igomba gucungwa ukurikije ubwoko bwa kabiri bwibikoresho byubuvuzi.

.Iyo ibicuruzwa nkibi birimo sodium hyaluronate, imicungire yabyo nibyiciro byo kuyobora ntabwo bihinduka.

(7) Sodium hyaluronate (sodium hyaluronate) ikurwa mubice byinyamanswa cyangwa ikorwa na fermentation ya mikorobe, ifite ingaruka zimwe zishobora kubaho.Umutekano ningirakamaro byibikoresho byubuvuzi byo mu cyiciro cya I ntibishobora kwemezwa ningamba zifatika.Kubwibyo, icyiciro cyo gucunga ibicuruzwa bya sodium hyaluronate (sodium hyaluronate) iyobowe nibikoresho byubuvuzi ntibigomba kuba munsi yicyiciro cya II.

(8) Sodium hyaluronate, nk'ibikoresho bitanga amazi kandi bitanga amazi, byakoreshejwe mu kwisiga.Ibicuruzwa birimo sodium hyaluronatezikoreshwa kuruhu, umusatsi, imisumari, iminwa nubundi buso bwabantu mukunyunyuza, gutera cyangwa ubundi buryo busa hagamijwe koza, kurinda, guhindura cyangwa kurimbisha, kandi ntibitangwa nkibiyobyabwenge cyangwa ibikoresho byubuvuzi.Ibicuruzwa nkibi ntibigomba gusabwa gukoreshwa mubuvuzi.

(9) amavuta yo kwisiga, yangiza kandiipambazirimo imiti yica udukoko ikoreshwa gusa mu kwanduza uruhu rwangiritse n'ibikomere ntibishobora gutangwa nk'ibiyobyabwenge cyangwa ibikoresho byo kwa muganga.

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(11) Kugirango dusobanure neza ibyashyizwe mubikorwa, hateganijwe ibibazo bijyanye no gusaba kwiyandikisha mubihe bitandukanye.Kubintu bijyanye no guhindura ibicuruzwa biranga ibicuruzwa cyangwa ibyiciro, igihe cyinzibacyuho cyo gushyira mu bikorwa imyaka igera kuri 2 gitangwa kugirango inzibacyuho igende neza.

UBUZIMAbizashyirwa mubyiciro bikurikije amategeko yigihugu.Dukurikije ihame ryo kuba inshingano kubakiriya, Hyaluronate izakomeza guteza imbere ibicuruzwa bishya bigamije guteza imbere ubuzima bwuruhu.