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IGlucagon generic iwina ukuvunywa kwe-FDA

IGlucagon generic iwina ukuvunywa kwe-FDAIzindaba

Izindaba ezinhle kubantu abanesifo sikashukela: Manje usunokhetho olujwayelekile lwe-glucagon yakho. Ukuphathwa Kwezokudla Nezidakamizwa e-U.S. Kugunyaze i-glucagon yokuqala ejwayelekile yokujova.





OKUSHIWO: Yini i-glucagon? | Isigqebhezana seGlucagon



I-FDA yamemezela ngoDisemba 28, 2020, ukuthi isivume isicelo esifushanisiwe sesidakamizwa se-glucagon somjovo 1 mg / vial ekitini eliphuthumayo, elenziwe yi-Amphastar Pharmaceuticals Inc. Le khithi ejwayelekile ye-glucagon izonikeza abantu ithuba lokuzelapha i-hypoglycemia enamandla, isimo esingaphazamisa amandla omuntu okusebenza ngokujwayelekile.

USally Choe, Ph.D., umqondisi weHhovisi Lezidakamizwa Ezijwayelekile e-FDA's Center for Drug Evaluation and Research, uqaphele ukuthi ukuvunywa kuyisinyathelo esikhulu phambili kubantu abanesifo sikashukela.

IGlucagon yomjovo ivunyelwe ukusetshenziswa e-US iminyaka engaphezu kwengu-20, kodwa kuze kube namuhla, akukaze kube khona okujwayelekile okuvunyelwe kwalomuthi obalulekile ongasindisa izimpilo zabantu abangahlangabezana nesimo esibi soshukela wegazi ophansi kakhulu, esho ku isitatimende .



Kungani kubalulekile ukulungela i-hypoglycemia enamandla

I-Hypoglycemia yenzeka lapho ushukela wegazi lakho, noma amazinga eglucose egazi, ehla kakhulu. Kungaba kusuka kumnene kuya kokubi. Izimpawu ezincane zingavela lapho ushukela wegazi lakho wehla ngaphansi kwama-70 mg / dL. Izimpawu ezilinganisiwe zenzeka lapho ushukela wegazi wehla phakathi kuka-55 no-70 mg / dL, ngokusho kuka I-JDRF . Izimpawu zingafaka ukuzwa ukujuluka okuncane, ukuqhaqhazela noma i-jittery, ukukhathazeka, ukucanuzela kwenhliziyo, ukulamba, noma ukukhathazeka, njengoba umzimba wakho uphendula ukwehla kweglucose egazini. I-hypoglycemia emnene noma elinganisiwe ingalashwa ngamaphilisi e-glucose noma isiphuzo esinoshukela njengejusi. Lezi carbs ezisebenza ngokushesha zingakhuphula amazinga kashukela egazini ngokushesha. Kepha lokho akwanele ukuxazulula isiqephu se-hypoglycemia esibi.

Lapho i-hypoglycemia iba nzima — amazinga angaphansi kuka-40-55 mg / dL — ungalahlekelwa amandla okusebenza noma weqe.Buza nodokotela wakho we-endocrinologist ukuthola ukuthi izinga le-glucose egazini lithathwa njengelibi kangakanani kuwe.Izimpawu ze-hypoglycemia enzima zingabandakanya ukukhuluma kanzima, ukungaboni kahle, ukunyakaza okungahambi kahle noma okunyanyisayo, ukozela, ukudideka nokuquleka, ngokusho kweMayo Clinic. I-hypoglycemia enamandla ingakhula kubantu abane-Type 1 noma Type 2 diabetes . Kodwa-ke, kuvame kakhulu kubantu abathatha i-insulin noma imithi yesifo sikashukela njenge-sulfonylureas.

I-American Diabetes Association ibhekisa esiqeshini seshukela eliphansi egazini esidinga usizo lwabanye njenge- umcimbi onzima . Umjovo we-glucagon ungasiza ngokushesha ukukhuphula amazinga kashukela egazini. Lokho kungenxa yokuthi i-glucagon inguqulo yokwenziwa kwehomoni ekhiqizwa kumanyikwe evusa isibindi ukuthi ikhulule i-glucose egciniwe ukuze ibuyise amazinga kashukela egazini lakho.



IGlucagen Hypokit, iphakethe lomjovo ophuthumayo, iqala ukukhuphula amazinga kashukela egazini kungakapheli imizuzu eyi-10 ngemuva kokujova. Imiphumela emibi ejwayelekile yemijovo ye-glucagon ukucanuzela kwenhliziyo, ukuhlanza, nokukhuphuka kwenhliziyo, kanye nokubomvu noma ukuvuvukala endaweni yokujova.

Izinzuzo zenketho ejwayelekile ye-glucagon

Ukwamukelwa kwe-glucagon generic kungasho ukonga okukhulu kubantu abanesifo sikashukela abadinga ukugcina ikiti esandleni.

Njengamanje ungathenga igama lomkhiqizo IGlucagen Hypokit , kepha kuya ngomshwalense wakho, kungabiza amakhulu ezinkulungwane zamadola. I-Medicare kwesinye isikhathi ihlanganisa izindleko, futhi amakhuphoni kwesinye isikhathi ayatholakala ukwehlisa intengo.



Kepha ungahle ukwazi ukuthola inguqulo entsha ejwayelekile maduzane. Ngemuva kwezindaba zokuvunywa kwe-FDA, u-Amphastar umemezele ukuthi uhlela ukwethula iGlucagon yayo ye-Injection Emergency Kit ezinyangeni ezimbili.

[Ukugunyazwa] kukhombisa ukuzibophezela okuqhubekayo kwe-FDA ekuqhubekiseleni phambili ukufinyelela kwesiguli emikhiqizweni yemithi ejwayelekile esezingeni eliphansi, esezingeni eliphezulu ephephe futhi esebenza kahle njengozakwabo begama lomkhiqizo, kusho uCoe.