Glucagon generic ya sami amincewar FDA

Labarai

Labari mai dadi ga mutanen da ke fama da ciwon sukari: Yanzu kuna da zaɓi na gaba ɗaya don glucagon ku. Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta amince da kwayar glucagon ta farko don allura.

Dangantaka: Menene glucagon? | Glucagon coupon

Hukumar ta FDA ta sanar a ranar 28 ga Disamba, 2020, cewa ta amince da wani gajarta da aka rage amfani da magani don maganin glucagon don allurar 1 mg / vial a cikin kayan agajin gaggawa, wanda kamfanin Amphastar Pharmaceuticals Inc. ya ƙera. mummunan hypoglycemia, yanayin da zai iya lalata ikon mutum na yin aiki daidai.

Sally Choe, Ph.D., darekta a Ofishin Magungunan Magunguna a Cibiyar Nazarin Bincike da Bincike na Magunguna na FDA, ta lura da yardar wani babban ci gaba ne ga mutanen da ke fama da ciwon sukari.

Glucagon don allura an yarda dashi don amfani dashi a cikin Amurka sama da shekaru 20, amma har zuwa yau, babu wani ingantaccen tsarin kwayar wannan magani mai mahimmanci wanda zai iya ceton rayukan mutane waɗanda zasu iya fuskantar mummunan yanayin cutar sikari mai ƙarancin jini, Ta ce a cikin wani sanarwa .

Me yasa yake da mahimmanci a shirya don tsananin hypoglycemia

Hypoglycemia na faruwa ne lokacin da sukarin jini, ko matakan glucose na jini, ya sauka ƙasa da ƙasa. Zai iya zama daga m zuwa mai tsanani. Symptomsananan alamu na iya faruwa yayin da sukarin jinin ku ya faɗi ƙasa da 70 mg / dL. Matsakaitan cututtuka na faruwa yayin da sukarin jini ya ragu tsakanin 55 zuwa 70 mg / dL, a cewar JDRF . Kwayar cututtukan na iya haɗawa da jin ɗan gumi, girgiza ko jiji, jin jiki, tashin zuciya, yunwa, ko damuwa, yayin da jikinka ke amsar digo cikin glucose na jini. Ana iya magance hypoglycemia mai sauƙi ko matsakaici tare da allunan glucose ko abin sha mai ƙanshi kamar ruwan 'ya'yan itace. Wadannan carbs masu saurin aiki na iya ɗaga matakan sukarin jini da sauri. Amma wannan bai isa ba don magance wani ɓangare na mummunan hypoglycemia.

Lokacin da hypoglycemia ya zama mai tsanani-matakan da ke ƙasa da 40-55 mg / dL-zaka iya rasa ikon aiki ko wucewa.Bincika tare da masanin ilimin likitan ku don sanin matakin glucose na jini da ake ganin mai tsanani ne a gare ku.Alamomin tsananin hypoglycemia na iya haɗawa da wahalar magana, hangen nesa, motsa jiki ko motsa jiki, bacci, rikicewa, har ma da kamuwa, a cewar Mayo Clinic. Tsananin hypoglycemia na iya bunkasa cikin mutanen da ke da ciwon Suga na 1 ko na Biyu . Duk da haka, ya fi kowa a cikin mutane wanda ke shan insulin ko magungunan suga kamar sulfonylureas.

Theungiyar Ciwon Suga ta Amurka tana nufin wani ɓangare na ƙarancin sukarin jini wanda ke buƙatar taimako daga wasu azaman mummunan lamari . Allurar glucagon na iya taimakawa da sauri haɓaka matakan sukarin jini. Wancan ne saboda glucagon sigar roba ce ta homonin da aka samar a cikin pancreas wanda ke motsa hanta don sakin glucose mai adanawa don dawo da matakan sukarin jininka.

Glucagen Hypokit, kunshin allurar gaggawa, yana farawa don haɓaka matakan sukarin jini cikin minti 10 bayan allura. Illolin dake tattare da allurar glucagon sune yawan tashin zuciya, amai, da kuma bugun zuciya, da kuma wani ja ko kumburi a wurin allurar.

Fa'idodin zaɓi na gamcagon na yau da kullun

Amincewa da tsarin jigilar abubuwa na iya nufin mahimman tanadi ga mutanen da ke fama da ciwon sukari waɗanda ke buƙatar adana kit a hannu.

A halin yanzu zaku iya sayan sunan-iri Glucagen Hypokit , amma dangane da inshorar ku, yana iya biyan dala ɗari da yawa. Medicare wani lokacin yakan biya kudin, kuma takardun shaida akwai wasu lokuta don rage farashin.

Amma kuna iya samun sabon salo gaba ɗaya. Bayan labarin amincewar FDA, Amphastar ya sanar da cewa yana shirin ƙaddamar da Glucagon don Kit ɗin gaggawa na Allura a cikin watanni biyu.

[Yarjejeniyar] ya nuna ci gaban FDA na ci gaba da ƙaddamar da haƙuri ga samun ƙananan kuɗi, kayayyakin ƙwayoyi masu inganci masu inganci waɗanda suke da aminci da tasiri kamar takwarorinsu na alama, Choe ya ce.