Dhawaan, Maamulka Cuntada iyo Dawooyinka ee Gobolka ayaa soo saaray Ogaysiis ku saabsan Qaybta Maareynta ee alaabta hyaluronate sodium (No. 103 ee 2022, ka dibna loo tixraaco No. 103 Ogaysiis).Asalka iyo nuxurka ugu muhiimsan ee dib-u-eegista ku dhawaaqista 103 waa sidan soo socota.
I. asalka dib u eegista
In 2009, Maamulka Cuntada iyo Dawooyinka ee hore ee Gobolka ayaa soo saaray Ogeysiis ku saabsan Qaybta Maareynta ee Sodium hyaluronate Products (No. 81 ee 2009, hadda ka dib waxaa loo tixraacaa Ogaysiinta No. 81) si loo hago loona habeeyo diiwaangelinta iyo kormeerka sodium hyaluronate caafimaad (No. sodium hyaluronate) alaabta la xidhiidha.Iyada oo horumarka degdega ah ee tignoolajiyada iyo warshadaha iyo soo bixitaanka alaabada cusub, Ogeysiinta 81 si buuxda uma dabooli karto baahida warshadaha iyo sharciyeynta.Sidaa darteed, Maamulka Cuntada iyo Dawooyinka ee Gobolka ayaa soo abaabulay dib u eegista ku dhawaaqista No. 81.
Ii.Dib u eegis ku saabsan waxa ugu muhiimsan
(a) Waqtigan xaadirka ah, wax soo saarka sodium hyaluronate (sodium hyaluronate) kaliya looma isticmaalo daawooyinka iyo aaladaha caafimaadka, laakiin sidoo kale inta badan waxaa loo isticmaalaa qurxinta, cuntada iyo qaybaha kale, alaabooyinka qaarkoodna waxaa lagu isticmaalaa cidhifka daawooyinka, qalabka caafimaadka iyo qurxinta. .Si si wanaagsan loo hago go'aaminta sifooyinka maamulka iyo qaybaha alaabta la xidhiidha, Ogeysiinta No. 103 ayaa ku daray mabda'a qeexida sifada maamulka ee alaabta cirifka ah iyo alaabta isku dhafka ah ee qalabka daawada ee ku lug leh sodium hyaluronate (sodium hyaluronate) iyo qalabka caafimaadka ee la xidhiidha mabda'a kala soocida alaabta. , oo qeexay sifada maamulka iyo qaybta alaabta la xidhiidha.
(2) Alaabooyinka hyaluronate sodium ee daawaynta cilladaha lakabka ilaalinta ee kaadiheysta kaadiheysta epithelial glucosamine ayaa loo oggolaaday suuqgeyn sida aaladaha caafimaadka Heerka III.Alaabta noocan oo kale ah looma oggola si waafaqsan xaaladda suuq-geynta daroogada, si loo ilaaliyo sii wadida maareynta, sii wad ilaalinta sifooyinka maamulka asalka ah.
(3) Marka badeecada sodium hyaluronate ee daawada loo isticmaalo duritaanka maqaarka iyo ka hooseeya, oo loo isticmaalo sida alaabta buuxinta duritaanka si loo kordhiyo mugga unugyada, haddii alaabtu aysan ku jirin maaddooyinka dawooyinka ee ciyaara daawooyinka farmashiyaha, dheef-shiid kiimikaadka ama difaaca jirka. waa in loo maamulaa sidii aaladda heerka III;Haddii alaabtu ay ka kooban tahay dawooyinka suuxinta gudaha iyo dawooyinka kale (sida lidocaine hydrochloride, amino acids, vitamins), waxa lagu qiimeeyaa inay tahay alaab la isku daray oo ku salaysan qalab caafimaad.
(4) Marka alaabta sodium hyaluronate ee daawada lagu duro maqaarka si loo hagaajiyo xaaladda maqaarka inta badan iyada oo loo marayo qoyaanka iyo fuuq-celinta sodium hyaluronate, haddii alaabtu aysan ku jirin maaddooyinka dawooyinka ee ciyaara saameynta daawooyinka, dheef-shiid kiimikaadka ama difaaca jirka, waa inay noqdaan loo maamulo iyadoo loo eegayo nooca saddexaad ee aaladaha caafimaadka;Haddii alaabtu ay ka kooban tahay dawooyinka suuxinta gudaha iyo dawooyinka kale (sida lidocaine hydrochloride, amino acids, vitamins, iwm.), waxaa lagu qiimeeyaa inay tahay alaab la isku daray oo ku salaysan qalab caafimaad.
(5) Ogeysiiska No. 81 wuxuu dhigayaa in "daawaynta… Alaabooyinka leh saameyn farmaajo oo qeexan sida boogaha maqaarka waa in loo maareeyaa si waafaqsan maamulka daroogada".Si kastaba ha noqotee, horumarinta sayniska iyo tignoolajiyada iyo fahamka qoto dheer ee hyaluronate sodium, waxaa guud ahaan la rumeysan yahay in bulshada cilmi-baarista sayniska marka sodium hyaluronate loo isticmaalo dhaymada caafimaadka, miisaan sare oo sodium hyaluronate ah oo lagu dabaqo boogaha maqaarka ayaa u hoggaansami kara dusha sare. nabarrada maqaarka oo nuugo tiro badan oo unugyo biyo ah.Si loo bixiyo jawi bogsiin qoyan oo loogu talagalay dusha boogta, si loo fududeeyo bogsashada dusha boogta, mabda'a ficilkeedu inta badan waa jir.Alaabooyinkan waxa loo habeeyey qalab caafimaad ahaan gudaha Maraykanka iyo Midowga Yurub.Sidaa darteed, dhaymo caafimaad oo lagu sheegay Bulletin 103 oo ay ku jiraan sodium hyaluronate ayaa loo habeeyey qalab caafimaad ahaan haddii aanay ku jirin maaddooyinka dawooyinka ee leh saamaynta dawooyinka, dheef-shiid kiimikaadka ama difaaca jirka;Haddii qayb ahaan ama gebi ahaanba uu jirka nuugo ama loo isticmaalo nabarrada raaga, waa in loo maareeyaa nooca saddexaad ee qalabka caafimaadka.Haddii uusan jirku nuugi karin oo loo isticmaalo nabarrada aan joogtada ahayn, waa in loo maareeyaa nooca labaad ee qalabka caafimaadka.
(6) Maaddaama agabka hagaajinta nabarrada ee gacan ka geysanaya hagaajinta iyo ka hortagga samaynta nabarrada maqaarku ee maqaarka lagu taxay "Qaybta Aaladaha Caafimaadka" 14-12-02 Qalabka dayactirka nabarrada, waa in loo maamulaa iyadoo loo eegayo aaladaha caafimaadka Qaybta II.Marka alaabada noocan oo kale ah ay ku jiraan sodium hyaluronate, hantidooda maaraynta iyo qaybaha maamulka isma beddelaan.
(7) Sodium hyaluronate (sodium hyaluronate) ayaa guud ahaan laga soo saaraa unugyada xoolaha ama ay soo saarto halsano microbial, kaas oo leh khataro gaar ah.Badbaadada iyo waxtarka qalabka caafimaadka ee Qaybta I laguma dammaanad qaadi karo tillaabooyin sharciyeed.Sidaa darteed, qaybta maaraynta ee alaabooyinka sodium hyaluronate (sodium hyaluronate) ee hoos yimaada maareynta qalabka caafimaadka waa inaysan ka hooseynin Qaybta II.
(8) Sodium hyaluronate, oo ah walxo qoyaan iyo fuuq-bax, ayaa loo adeegsaday qurxinta.Alaabooyinka ay ku jiraan sodium hyaluronatekuwaas oo lagu marsado maqaarka, timaha, cidiyaha, dibnaha iyo meelaha kale ee bini'aadamka iyada oo la xoqayo, buufinayo ama hababka kale ee la midka ah ee ujeedada nadiifinta, ilaalinta, wax ka beddelka ama qurxinta, oo aan loo maamulin dawo ahaan ama qalab caafimaad.Alaabta noocan oo kale ah waa in aan loo dalban isticmaalka caafimaad.
(9) lotion, jeermis dileyaal iyosuufka suufkaka kooban jeermis-dile loo isticmaalo oo kaliya jeermiska maqaarka dhaawacan iyo nabarrada waa in aan loo isticmaalin daawo ahaan ama qalab caafimaad.
(10) Haddii sifooyinka jidheed, kiimikaad iyo bayooloji ee sodium hyaluronate la beddelay ay la socdaan kuwa sodium hyaluronate ka dib xaqiijinta, sifooyinka maamulka iyo qaybaha maamulka waa la hirgelin karaa iyadoo la tixraacayo Ogeysiintan.
(11) Si loo caddeeyo shuruudaha fulinta, arrimaha khuseeya codsiga diiwaangelinta xaaladaha kala duwan ayaa lagu qeexay.Xaaladaha ku lug leh isbeddelka sifooyinka maamulka alaabta ama qaybaha, muddada ku-meel-gaarka ah ee hirgelinta ee ku saabsan 2 sano ayaa la bixiyaa si loo hubiyo kala-guurka fudud.
CAAFIMAADsi adag ayaa loo kala saari doonaa si waafaqsan xeerarka qaranka.Iyadoo la raacayo mabda'a mas'uulka ka ah macaamiisha, Hyaluronate waxay sii wadi doontaa horumarinta alaabada cusub si kor loogu qaado caafimaadka maqaarka.
Waqtiga boostada: Nov-23-2022