Xinhua | Ukuhlaziywa: 2020-11-11 09:20
Ifayile yeFayile: I-Weli Lilly yophawu iboniswe kwenye yee-ofisi zeNkampani eSan Diego, eCalifornia, i-US, kaSeptemba 17, 2020. [Ifoto / iiarhente / ii-foto]
UWashington -Ukutya kuka-US kunye noLawulo lweziyobisi ukhuphe isigunyaziso sohlaziyo sexesha likaxakeka (i-EUA) ye-American StsMaker ye-Eilly Entiy's Antiy-19 kwi-Avid-19 kubantu abadala kunye nabaguli abasebenza.
Ichiza, iBamlanivimab, igunyazisiweCovid-19 izigulanaNgoobani abaneminyaka eli-12 ubudala kwaye banobunzima obudala ubuncinci beekhilogramu ezingama-40, kwaye abasemngciphekweni omkhulu wokuqhubela phambili ukuya kuthi ga kwi-Covid-19 kunye (okanye) kwiNkcazo ye-FDA ngoMvulo.
Oku kubandakanya abo baneminyaka engama-65 ubudala okanye ngaphezulu, okanye abaneemeko zonyango ezingapheliyo.
Iiproteni ze-monoclonn antibodies yiproteni yelebhu ezenziwe amaphunzi ezenza ukulinganisa amandla omzimba okulwa neebhibhisi ezinobungozi njengeentsholongwane. I-Bamlanivimab yi-monoclonnikal antid forder ejolise ngqo kwiproteni ye-SPIKE ye-SARS-2, eyilelwe ukuvimba intsholongwane kunye nokungena kwiiseli zabantu.
Ngelixa ukhuseleko kunye nokusebenza kolu nyango uphando kuqhubeka kuvavanywa, iBamlanivimab yaboniswa kwiimvavanyo zeklinikhi ukunciphisa unyango olunxulumene nesifo kwi-28 emva konyango xa kuthelekiswa ne-placebo, yatsho i-FDA.
Idatha exhasa i-EUA ye-EAMLAIAB isekwe kuhlalutyo lwethutyana ukusuka kwisigaba sesigaba esibini, ilawulwa kabini, ukulawulwa kweklinikhi elawulwa esibhedlele kubantu abadala abangenasibhedlele kubantu abadala abangama-465 abangabameli ngokumodareyitha ngokumodareyitha i-Covid-19 i-19.
Aba baguli, i-101 ifumene idosi ye-700 -ilram yeBamlanivimab, i-107 yedosi ye-milligram, i-10,000 -ilram -ilram-ifumene i-Pool-Mese kwaye ifumene uvavanyo lwentsholongwane.
Ukuze izigulana ezisemngciphekweni omkhulu wezifo, ukutyelelwa esibhedlele kunye negumbi likaxakeka (i-ER) lenzeka kwiipesenti ezi-3 zeBambanivimab-i-Bamlanivimab-i-APRING kwi-10 ipesenti ezazithwaliswa zi-10.
Iziphumo zomthwalo wentsholongwane kunye nokuncitshiswa kwesibhedlele kunye notyelelo, kwaye kukhuseleko, zazifana nezigulana ezifumana iidosi ezintathu zeBallanivimab, ngokwe-FDA.
I-EUA ivumela iBamlanivimab ukuba isasazwe kwaye ilawulwe njengedosi enye ngokulandelelana kwababoneleli bezempilo.
"Ugunyaziso lwe-FDA lukaBamlanivimab lubonelela ngoochwephesha bezempilo kwi-pundemic kunye nesinye isixhobo esinokubakho xa siphatha i-Covidz's Pavidzni," utshilo uPatrize kwiziko le-FDA nophando. "Siza kuqhubeka nokuvavanya idatha entsha ekukhuseleni nasekusebenziseni ukusebenza kweBamlanivimab njengoko befumaneka."
Ngokusekwe kuphononongo lwezinto ezinobungqina bezenzululwazi ezikhoyo, i-FDA igqibe kwelokuba kufanelekile ukukholelwa ukuba iBamlanivimab inokusebenza ngokunyanga abaguli abangabhalwanga esibhedlele okanye bamongaleleyo - 19. Kwaye, xa isetyenziselwa ukuphatha iCoVid-19 yabantu abagunyazisiweyo, izibonelelo ezaziwayo nezinokubakho ziyingozi kakhulu imingcipheko eyaziwayo nenokubakho kwichiza, ngokwe-FDA.
Iziphumo ezinokwenzeka zeBamlanivimab zibandakanya i-Anaphylaxis kunye ne-Ascoctions enxulumene nembeko, isicaphucaphu, isiyezi, isiyezi, intloko ebuhlungu, iyagabha, ngokwe-Arhente.
I-EUA yenzeka njengoko i-United States igqithile kwi-10 yezigidi ze-10 tids-Pages, kwiintsuku nje ezili-10 emva kokubetha izigidi ezi-9. Inani elivisine lemidlalo yobisi yonke lemihla ngemihla igqithile kwi-100,000, iingcali zempilo yoluntu ziye zalumkisa ukuba ilizwe lingenise isigaba esibi kabhubhane.
I-Post Time: Dec-19 ukuya ku-2021