Umbhali: Virginia Floyd
Umhla Wokudalwa: 10 Eyethupha 2021
Hlaziya Umhla: 15 Eyenkanga 2024
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FDA Approval of Enspryng™ For Neuromyelitis Optica Spectrum Disorder (NMOSD)
Ividiyo: FDA Approval of Enspryng™ For Neuromyelitis Optica Spectrum Disorder (NMOSD)

Umxholo

Inaliti yeSatralizumab-mwge isetyenziselwa ukunyanga isifo se-neuromyelitis optica spectrum disorder (i-NMOSD; ukuphazamiseka okuzenzekelayo kwenkqubo yeemvakalelo echaphazela imithambo-luvo yamehlo kunye nentambo yomqolo) kubantu abadala abathile. I-Satralizumab-mwge ikudidi lwamayeza abizwa ngokuba yi-interleukin-6 (IL-6) receptor inhibitors. Isebenza ngokuthintela umsebenzi wenxalenye yamajoni omzimba onokonakalisa iindawo ezithile zenkqubo yeemvakalelo kubantu abaneNMOSD.

I-Satralizumab-mwge iza njengesisombululo (ulwelo) sokufaka ngenaliti (phantsi kolusu). Ihlala itofwe kanye kwiiveki ezimbini kwiidosi zokuqala ezi-3 kwaye kube kanye emva kweeveki ezi-4 ukuba ugqirha ucebisa ukuba ufumane unyango. Ugqirha wakho unokuthatha isigqibo sokuba wena okanye umntu omkhathalelayo unokwenza inaliti ekhaya. Ugqirha wakho uyakukubonisa okanye umntu oza kuthi afake iyeza ukuba ungalitofa njani. Wena okanye umntu oza kutofa iyeza kufuneka ufunde imiyalelo ebhaliweyo yokusetyenziswa okuza nonyango. Qiniseka ukuba ubuza ugqirha okanye usokhemesti ukuba unayo nayiphi na imibuzo malunga nokuba ungalifaka njani iyeza.


Susa ibhokisi equkethe amayeza kwifriji kwimizuzu engama-30 ngaphambi kokuba ulungele ukutofa amayeza. Jonga ibhokisi ukuze uqiniseke ukuba umhla wokuphelelwa oprintwe kwiphakheji awudlulanga. Vula ibhokisi kwaye ususe isirinji. Jonga ngokusondeleyo ulwelo kwisirinji. Umbane kufuneka ucace kwaye ungabinambala ube tyheli kancinane kwaye akufuneki ubenamafu okanye umbala okanye ubenamasuntswana. Fowunela usokhemesti wakho ukuba kukho naziphi na iingxaki kwaye ungalitofisi iyeza. Beka isirinji kwindawo ethe tyaba kwaye uyivumele ukuba ifikelele kubushushu begumbi. Musa ukushukumisa isirinji. Sukuzama ukufudumeza amayeza ngokuwatshisa kwimicrowave, ngokuwabeka emanzini afudumeleyo okanye elangeni ngqo, okanye ngayo nayiphi na enye indlela.

Unokufaka inaliti ye-satralizumab-mwge ngaphambili naphakathi kwamathanga okanye naphina esiswini sakho ngaphandle kwenkaba yakho (iqhosha lesisu) kunye nendawo eyi-intshi ezi-2 ezijikeleze yona. Musa ukujova iyeza kulusu oluthambileyo, olonzakeleyo, olonakeleyo okanye olunezikrobo. Guqula (ujikeleze) indawo yenaliti ngenaliti nganye. Khetha indawo eyahlukileyo ngalo lonke ixesha utofa iyeza. Sebenzisa isirinji kwimizuzu emi-5 ususile ikepusi okanye inaliti ingavala.


Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwesigulana lomenzi (Isikhokelo seyeza) xa uqala unyango ngenaliti ye-satralizumab-mwge kwaye ngalo lonke ixesha ugcwalisa amayeza akho. Funda ulwazi ngononophelo kwaye ubuze ugqirha okanye usokhemesti ukuba unayo nayiphi na imibuzo. Ungandwendwela noLawulo lwezoKutya noLawulo lweziyobisi (FDA) iwebhusayithi (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) okanye iwebhusayithi yomenzi ukufumana isiKhokelo seMithi.

Eli yeza linokumiselwa ezinye izinto; buza ugqirha wakho okanye usokhemesti ngolwazi oluthe kratya.

Ngaphambi kokusebenzisa inaliti ye-satralizumab-mwge,

  • xelela ugqirha wakho kunye nosokhemesti ukuba ngaba uxabisa i-satralizumab-mwge, nawaphi na amanye amayeza, okanye naziphi na izithako kwiinaliti ye-satralizumab-mwge. Buza usokhemesti wakho okanye ujonge isiKhokelo seyeza ukuze ufumane uluhlu lwezithako.
  • xelela ugqirha wakho kunye nosokhemesti ukuba loluphi olunye amayeza amiselweyo kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye nemveliso yamayeza owathathayo okanye oceba ukuyithatha. Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
  • xelela ugqirha wakho ukuba unesifo sephepha okanye isifo sephepha (isifo sokuhlasela kwemiphunga) okanye i-hepatitis B (HBV; intsholongwane echaphazela isibindi). Ugqirha wakho uza kuvavanya ukuze abone ukuba une-TB okanye i-HBV ngaphambi kokuba uqale unyango lwakho. Ukuba une-TB okanye i-HBV, ugqirha wakho uya kuthi kuwe ungasebenzisi inaliti ye-satralizumab-mwge.
  • xelela ugqirha wakho ukuba unentsholongwane okanye ukhe wanxibelelana nomntu onesifo sephepha. Kwakhona xelela ugqirha wakho ukuba unesifo sesibindi.
  • xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ukhulelwa ngelixa usebenzisa i-satralizumab-mwge, biza ugqirha wakho.
  • buza ugqirha wakho ukuba ufanele ukufumana naluphi na ugonyo ngaphambi kokuba uqale unyango lwakho ngenaliti ye-satralizumab-mwge. Awunalo ugonyo ngaphambi okanye ngexesha lonyango ngaphandle kokuthetha nogqirha wakho.

Ngaphandle kokuba ugqirha wakho akuxelele ngenye indlela, qhubeka nokutya okuqhelekileyo.


Ukuba uphosa idosi yesatralizumab-mwge, tsalela ugqirha wakho malunga nokuqala kwakhona ishedyuli yonyango.

I-Satralizumab-mwge inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

  • isicaphucaphu
  • intlungu edibeneyo okanye yemisipha
  • iintlungu ezandleni okanye ezinyaweni
  • ukudakumba
  • intloko ebuhlungu

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba unazo naziphi na kwezi mpawu, biza ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

  • umkhuhlane, ukukhohlela, urhudo, ukuphuma empumlweni, umqala obuhlungu, ukugodola, iintlungu, ukutshisa xa uchama, uchama kaninzi kunesiqhelo okanye ezinye iimpawu zosulelo
  • ububomvu bolusu, ukudumba, ukuthamba, iintlungu okanye izilonda
  • irhashalala okanye urticaria
  • ukudumba kobuso, imilebe, okanye ulwimi
  • ubunzima bokuginya okanye ukuphefumla

I-Satralizumab-mwge inokubangela ezinye iziphumo ebezingalindelekanga. Biza ugqirha wakho ukuba unayo nayiphi na ingxaki engaqhelekanga ngelixa usebenzisa eli yeza.

Ukuba uhlangabezana neziphumo ebezingalindelekanga ezimandundu, wena okanye ugqirha wakho ungathumela ingxelo kwiNkqubo yoKutya kunye nezoLawulo (i-FDA) yeMedWatch yeNkqubo yokuNgxelo ngezeMeko eziGwenxa kwi-Intanethi (http://www.fda.gov/Safety/MedWatch) okanye ngomnxeba ( 1-800-332-1088).

Gcina la mayeza kwisitya angene ngaphakathi, avalwe ngokuqinileyo, ngaphandle kokufikelela kwabantwana, kwaye kude nokukhanya. Gcina iisirinji ezizaliswe ngaphambili kwifriji; sukuma ngumkhenkce. Iibhokisi ezingavulwanga ezineesirinji zingasuswa kwaye zibuyiselwe kwifriji, kodwa akufuneki ziphume ngaphandle kwefriji ixesha elingaphezulu kweentsuku ezisi-8.

Kubalulekile ukugcina onke amayeza ngaphandle kwamehlo kunye nokufikelela kwabantwana njengezikhongozeli ezininzi (ezinje ngeeveki zeepilisi zeveki kunye nezo zamehlo, iikhrim, iipatches, kunye ne-inhalers) azinyangeki kwaye abantwana abancinci banokuzivula ngokulula. Ukukhusela abantwana abancinci kwiityhefu, soloko ukhiya iminqwazi yokhuseleko kwaye ubeke amayeza kwindawo ekhuselekileyo-leyo iphakame kwaye iphakame kwaye ingabonakali kubo kwaye ifikelele kuyo. http://www.upandaway.org

Amayeza angafunekiyo kufuneka achithwe ngeendlela ezizodwa zokuqinisekisa ukuba izilwanyana zasekhaya, abantwana kunye nabanye abantu abanakuzisebenzisa. Nangona kunjalo, akufuneki uligungxule eli yeza kwindlu yangasese. Endaweni yoko, eyona ndlela yokulahla amayeza akho yinkqubo yokubuyisa amayeza. Thetha kumayeza wakho okanye unxibelelane nesebe lakho lenkunkuma / lokurisayikilisha ukuze ufunde malunga neenkqubo zokubuyisa kwindawo ohlala kuyo. Jonga i-FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) ngolwazi oluthe kratya ukuba awunakho ukufikelela kwinkqubo yokubuyisa.

Kwimeko yokugqithisa, fowunela umnxeba wolawulo lwetyhefu kwi-1-800-222-1222. Ulwazi lukwafumaneka kwi-Intanethi kwi-https: //www.poisonhelp.org/help. Ukuba ixhoba liye lawa, laxhuzula, linengxaki yokuphefumla, okanye alikwazi ukuvuswa, ngoko nangoko lifowunele iinkonzo zongxamiseko ngo-911.

Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho uya kuyalela iimvavanyo ezithile zebhu ngaphambi nangexesha lonyango lwakho ukujonga impendulo yomzimba wakho kwi-satralizumab-mwge.

Musa ukuvumela omnye umntu asebenzise amayeza akho. Buza usokhemesti wakho nayiphi na imibuzo onayo malunga nokuzalisa amayeza akho.

Kubalulekile ukuba ugcine uluhlu olubhaliweyo lwawo onke amayeza owasebenzisayo amayeza owasebenzisayo, kunye nezinye iimveliso ezinjengeevithamini, iiminerali, okanye ezinye izongezo zokutya. Kuya kufuneka uze nolu luhlu qho xa undwendwela ugqirha okanye ungeniswe esibhedlele. Kukwabalulekile ulwazi ukuba uphathe nawe xa kukho imeko kaxakeka.

  • Enspryng®
Ukuhlaziywa kokugqibela- 12/15/2020

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