Ukujova kweBamlanivimab

-Delile

• Ngaphambi kokuthola u-bamlanivimab,
• I-Bamlanivimab ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezisesigabeni se-HOW, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo.

Ngo-Ephreli 16, 2021, i-US Food and Drug Administration ikhansele i-Emergency Use Authorization (EUA) yokujova i-bamlanivimab ukuze isetshenziswe yodwa ekwelapheni isifo se-coronavirus 2019 (COVID-19) esibangelwe yigciwane le-SARS-CoV-2. Ngenxa yokwanda kokuhlukahluka kwegciwane le-SARS-CoV-2 elingazweli ekusebenziseni i-bamlanivimab kuphela, i-FDA inqume ukuthi izinzuzo zokusebenzisa lo muthi azisasekelwa. Kodwa-ke, umjovo we-bamlanivimab uhlanganiswe nomjovo we-etesevimab uyaqhubeka nokugunyazwa ngaphansi kwe-EUA ekwelapheni i-COVID-19.

Umjovo weBamlanivimab usafundelwa ukwelashwa kwesifo se-coronavirus 2019 (COVID-19) esidalwa yigciwane le-SARS-CoV-2.

Imininingwane yesivivinyo somtholampilo ekhawulelwe kuphela etholakalayo ngalesi sikhathi ukuxhasa ukusetshenziswa kwe-bamlanivimab ekwelashweni kwe-COVID-19. Imininingwane eminingi iyadingeka ukwazi ukuthi i-bamlanivimab isebenza kanjani ekwelapheni i-COVID-19 kanye nemicimbi engemihle evela kuyo.

Umjovo weBamlanivimab awukaze ubuyekezwe ngokujwayelekile ukuze uvunyelwe yi-FDA ukuthi isetshenziswe.Kodwa-ke, i-FDA ivume Ukugunyazwa Kokusetshenziswa Okuphuthumayo (i-EUA) ukuvumela abantu abadala nabangekho esibhedlela abanezingane ezineminyaka engu-12 nangaphezulu abanezimpawu ze-COVID-19 eziphakathi nendawo zokuthola umjovo we-bamlanivimab.

Khuluma nodokotela wakho ngezingozi nezinzuzo zokuthola lo muthi.

Umjovo weBamlanivimab usetshenziselwa ukwelapha ukutheleleka kwe-COVID-19 kubantu abadala abathile abangalalisiwe esibhedlela nezingane ezineminyaka engu-12 ubudala nangaphezulu ezinesisindo okungenani esingamakhilogremu angama-40 (40 kg) futhi ezinezimpawu ze-COVID-19 eziphakathi nendawo kuya kokulingene. Isetshenziswa kubantu abanezimo ezithile zezempilo ezibenza babe sengozini enkulu yokuthola izimpawu ezinzima ze-COVID-19 noma isidingo sokulaliswa esibhedlela ngenxa yokutheleleka nge-COVID-19. UBamlanivimab usesigabeni semithi ebizwa ngama-antibody monoclonal. Isebenza ngokuvimba ukusebenza kwento ethile yemvelo emzimbeni ukunqanda ukusabalala kwegciwane.

IBamlanivimab iza njengesisombululo (uketshezi) ukuhlanganiswa noketshezi bese ujovwa kancane emthanjeni ngaphezu kwemizuzu engama-60 ngudokotela noma unesi. Inikezwa njengomthamo wesikhathi esisodwa ngokushesha okukhulu ngemuva kokuhlolwa okuhle kwe-COVID-19 futhi kungakapheli izinsuku eziyi-10 ngemuva kokuqala kwezimpawu zokutheleleka ze-COVID-19 ezinjengomkhuhlane, ukukhwehlela, noma ukuphefumula okuncane.

Umjovo we-Bamlanivimab ungadala ukusabela okubucayi noma okusongela impilo ngesikhathi sokufakwa komuthi nangemva kwawo. Udokotela noma umhlengikazi uzokuqapha ngokucophelela ngenkathi uthola umuthi futhi okungenani ihora elilodwa ngemuva kokuwuthola. Tshela udokotela wakho noma umhlengikazi ngokushesha uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi sokumnika noma ngemuva: umkhuhlane; Ukugodola; isicanucanu; ikhanda; ukuphelelwa umoya; umfutho wegazi ophakeme noma ophansi; ukushaya kwenhliziyo okuhamba kancane noma okusheshayo; ubuhlungu besifuba noma ukungahambi kahle; ubuthakathaka; ukudideka; ukukhathala; ukushaya; ukuqubuka, isifuba, noma ukulunywa; ubuhlungu bemisipha noma ubuhlungu; isiyezi; ukujuluka; noma ukuvuvukala kobuso, umphimbo, ulimi, noma izindebe. Udokotela wakho angadinga ukwehlisa ukumnika kwakho noma ayeke ukwelashwa kwakho uma uhlangabezana neminye yale miphumela emibi.

Buza usokhemisi noma udokotela wakho ikhophi lemininingwane yomkhiqizi yesiguli.

Lo muthi ungabekelwa okunye ukusetshenziswa; buza udokotela wakho noma usokhemisi ukuthola eminye imininingwane.

Ngaphambi kokuthola u-bamlanivimab,

• Tshela udokotela kanye nosokhemisi wakho uma unegciwane ku-bamlanivimab, noma imiphi eminye imithi, noma yiziphi izithako zomjovo we-bamlanivimab. Buza usokhemisi wakho ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi eminye imishanguzo kadokotela neyokungabhalisi, amavithamini, izithasiselo zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi eminye imishanguzo kadokotela neyokungabhalisi, amavithamini, izithasiselo zokudla okunempilo, nemikhiqizo yamakhambi oyithathayo noma ohlela ukuyithatha. Qiniseka ukuthi usho noma yikuphi okulandelayo: imishanguzo yokuzivikela njenge-cyclosporine (Gengraf, Neoral, Sandimmune), prednisone, ne-tacrolimus (i-Astagraf, i-Envarsus, i-Prograf). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• utshele udokotela wakho uma ngabe uke waba nezimo zezempilo noma wake waba nazo.
• tshela udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uma ukhulelwa ngenkathi uthola i-bamlanivimab, shayela udokotela wakho.

Ngaphandle kokuthi udokotela wakho akutshele ngenye indlela, qhubeka nokudla okuvamile.

I-Bamlanivimab ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• isifo sohudo
• ukopha, ukulimaza, ubuhlungu, ubuhlungu, noma ukuvuvukala endaweni yokujova

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezisesigabeni se-HOW, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo.

• imfiva
• ukuphefumula kanzima
• izinguquko ekushayeni kwenhliziyo
• ukukhathala noma ubuthakathaka
• ukudideka

Umjovo we-Bamlanivimab ungadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthola lo muthi.

Uma uthola imiphumela emibi kakhulu, wena noma udokotela wakho ungathumela umbiko kuhlelo lwe-Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting online (http://www.fda.gov/Safety/MedWatch) noma ngocingo ( 1-800-332-1088).

Gcina wonke ama-aphoyintimenti nodokotela wakho.

Buza usokhemisi wakho noma imiphi imibuzo onayo ngomjovo we-bamlanivimab.

Kufanele uqhubeke nokuzihlukanisa njengoba uqondiswe ngudokotela wakho futhi ulandele imikhuba yezempilo yomphakathi njengokugqoka imaski, ukuqhela emphakathini, nokugeza izandla kaningi.

Kubalulekile ukuthi ugcine uhlu olubhaliwe lwayo yonke imishanguzo oyisebenzisayo kadokotela kanye nokungabhaliswanga (ngaphezulu kokuthenga), kanye nanoma yimiphi imikhiqizo efana namavithamini, amaminerali, noma ezinye izithako zokudla. Kufanele uze nalolu hlu njalo uma uvakashela udokotela noma uma ungeniswa esibhedlela. Kubaluleke kakhulu futhi nemininingwane ebalulekile ukuthi uphathe uma kwenzeka kunezimo eziphuthumayo.

I-American Society of Health-System Pharmacists, Inc. imele ukuthi lolu lwazi olumayelana ne-bamlanivimab lwenziwa ngezinga elifanele lokunakekelwa, nangokuhambisana nezindinganiso zobungcweti emkhakheni. Abafundi bayaxwayiswa ukuthi i-bamlanivimab akuyona indlela yokwelashwa evunyelwe isifo se-coronavirus 2019 (i-COVID-19) ebangelwe yi-SARS-CoV-2, kodwa kunalokho, iyaphenywa futhi okwamanje iyatholakala ngaphansi, kwemvume yokusebenzisa i-FDA eziphuthumayo (EUA) ukwelashwa kwe-COVID-19 emnene kuya kokulingene kwezinye iziguli eziphuma ngaphandle. I-American Society of Health-System Pharmacists, Inc. ayenzi izethulo noma amawaranti, ayivezi noma asikiswanga, kufaka phakathi, kodwa kungagcini, kunoma yisiphi isiqinisekiso esisetshenzisiwe sokuthengiselana kanye / noma ukuqina ngenhloso ethile, maqondana nolwazi, futhi ikakhulukazi izilahla zonke lezi ziqinisekiso. Abafundi bolwazi olumayelana ne-bamlanivimab bayelulekwa ukuthi i-ASHP ayinasibopho semali eqhubekayo yolwazi, nganoma yimaphi amaphutha noma ukushiywa, kanye / noma eminye imiphumela evela ekusetshenzisweni kwalolu lwazi. Abafundi bayelulekwa ukuthi izinqumo maqondana nokwelashwa kwezidakamizwa ziyizinqumo eziyinkimbinkimbi zezokwelapha ezidinga isinqumo esizimele, esinolwazi sompetha ofanele wezokunakekelwa kwezempilo, futhi imininingwane equkethwe yilolu lwazi inikezwa ngenhloso yokwaziswa kuphela. I-American Society of Health-System Pharmacists, Inc. ayikukhuthazi noma ukuncoma ukusetshenziswa kwanoma imuphi umuthi. Lolu lwazi olumayelana ne-bamlanivimab akufanele lubhekwe njengeseluleko somuntu ngamunye. Ngenxa yokushintsha kwemininingwane yolwazi ngezidakamizwa, uyelulekwa ukuba ubonane nodokotela noma usokhemisi wakho mayelana nokusetshenziswa kwemitholampilo kwanoma imuphi umuthi.

• akekho