Inaliti ye-Bamlanivimab

Umxholo

• Phambi kokufumana u-bamlanivimab,
• I-Bamlanivimab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:
• Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zikwicandelo le-INDLELA, biza ugqirha ngokukhawuleza okanye ufumane unyango olukhawulezileyo.

Ngo-Epreli 16, 2021, i-US yoLawulo lwezoKutya kunye noLawulo lweeDrug irhoxise iSigunyaziso sokuSetyenziswa okungxamisekileyo (i-EUA) ngenaliti ye-bamlanivimab yokusetyenziswa yodwa kunyango lwe-coronavirus isifo se-2019 (i-COVID-19) ebangelwa yintsholongwane ye-SARS-CoV-2. Ngenxa yokwanda kokungafaniyo kwintsholongwane ye-SARS-CoV-2 enganyangekiyo ekusebenziseni i-bamlanivimab iyodwa, i-FDA ithathe isigqibo sokuba izibonelelo zokusebenzisa eli yeza azisaxhaswa. Nangona kunjalo, inaliti ye-bamlanivimab ngokudibeneyo nenaliti ye-etesevimab iyaqhubeka nokugunyaziswa phantsi kwe-EUA kunyango lwe-COVID-19.

Inaliti ye-Bamlanivimab ngoku ifundelwa unyango lwe-coronavirus isifo se-2019 (i-COVID-19) ebangelwa yintsholongwane ye-SARS-CoV-2.

Ulwazi olulinganiselweyo kuphela lwezonyango olukhoyo ngeli xesha lokuxhasa ukusetyenziswa kwe-bamlanivimab kunyango lwe-COVID-19. Ulwazi oluthe kratya luyafuneka ukuze wazi ukuba isebenza njani i-bamlanivimab kunyango lwe-COVID-19 kunye neziganeko ezimbi ezivela kuyo.

Inaliti ye-Bamlanivimab khange ifumane uphononongo oluqhelekileyo ukuze luvunyiwe yi-FDA ukuba isetyenziswe.Nangona kunjalo, i-FDA ivume iSigunyaziso sokuSetyenziswa ngokuNgxamisekileyo (i-EUA) ukuvumela abantu abadala abangalaliswanga esibhedlele kunye nabantwana abaneminyaka eli-12 ubudala nangaphezulu abanobulali ukuya kuthi ga kwiimpawu ze-COVID-19 zokufumana inaliti ye-bamlanivimab.

Thetha nogqirha wakho malunga nobungozi kunye nezibonelelo zokufumana eli yeza.

Inaliti ye-Bamlanivimab isetyenziselwa ukunyanga usulelo lwe-COVID-19 kubantu abadala abangalaliswanga esibhedlele nakubantwana abaneminyaka eli-12 ubudala nangaphezulu abanobunzima obungama-88 eekhilogram (40 kg) nabaneempawu ze-COVID-19 eziphakathi ukuya kwezimnene. Isetyenziswa kubantu abaneemeko ezithile zonyango ezibenza babe semngciphekweni omkhulu wokukhula kweempawu ezinzima ze-COVID-19 okanye isidingo sokulaliswa esibhedlele kukosuleleka yi-COVID-19. U-Bamlanivimab ukwiklasi yamayeza abizwa ngokuba yi-monoclonal antibodies. Isebenza ngokuthintela isenzo sento ethile yendalo emzimbeni ukunqanda ukusasazeka kwentsholongwane.

I-Bamlanivimab iza njengesisombululo (ulwelo) sokudityaniswa nolwelo kwaye kutofwe kancinci emthanjeni ngaphezulu kwemizuzu engama-60 ngugqirha okanye ngumongikazi. Inikwa njengedosi yexesha elinye ngokukhawuleza emva kovavanyo oluqinisekileyo lwe-COVID-19 kwaye kwiintsuku ezili-10 emva kokuqala kweempawu ze-COVID-19 zosulelo ezinje ngomkhuhlane, ukukhwehlela, okanye ukuphefumla kancinci.

Inaliti ye-Bamlanivimab inokubangela ukusabela okunobuzaza okanye okusongela ubomi ngexesha nasemva kokufakwa kweyeza. Ugqirha okanye umongikazi uya kukujonga ngononophelo ngelixa ufumana amayeza kwaye ubuncinci iyure emva kokuba uwafumene. Xelela ugqirha wakho okanye umongikazi kwangoko ukuba unazo naziphi na kwezi mpawu zilandelayo ngexesha okanye emva kokufakwa: ifiva; Ukugodola; isicaphucaphu; intloko ebuhlungu; ukuqhawukelwa ngumphefumlo; uxinzelelo lwegazi oluphezulu okanye oluphantsi; ukubetha kwentliziyo kancinci okanye okukhawulezayo; iintlungu esifubeni okanye ukungaphatheki kakuhle; ubuthathaka; ukudideka; ukudinwa; ukuvutha; irhashalala, urticaria, okanye ukurhawuzelela; iintlungu zemisipha okanye iintlungu; isiyezi; ukubila; okanye ukudumba kobuso, umqala, ulwimi, okanye imilebe. Ugqirha wakho unokufuna ukunciphisa ukunyuswa kwakho okanye ayeke unyango lwakho ukuba unazo naziphi na iziphumo ebezingalindelekanga.

Buza usokhemesti okanye ugqirha wakho ngekopi yolwazi lomenzi wesigulana.

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

Phambi kokufumana u-bamlanivimab,

• xelela ugqirha wakho kunye nosokhemisti ukuba ngaba uxabisa i-bamlanivimab, nawaphi na amanye amayeza, okanye naziphi na izithako kwiinaliti ze-bamlanivimab. Buza usokhemesti wakho 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 kunye nosokhemesti ukuba loluphi olunye amayeza amiselweyo kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye nemveliso yamayeza owathathayo okanye oceba ukuyithatha. Qiniseka ukuba ukhankanya nayiphi na kwezi zinto zilandelayo: amayeza e-immunosuppressive anjenge cyclosporine (Gengraf, Neoral, Sandimmune), prednisone, kunye ne tacrolimus (Astagraf, Envarsus, Prograf). Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
• xelela ugqirha wakho ukuba ukhe wakha naziphi na iimeko zonyango.
• xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ukhulelwa ngelixa ufumana i-bamlanivimab, biza ugqirha wakho.

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

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

• urhudo
• ukopha, ukugruzuka, iintlungu, ukukhathazeka, okanye ukudumba kwindawo yenaliti

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zikwicandelo le-INDLELA, biza ugqirha ngokukhawuleza okanye ufumane unyango olukhawulezileyo.

• ifiva
• ubunzima bokuphefumla
• utshintsho kwintliziyo
• ukudinwa okanye ubuthathaka
• ukudideka

Inaliti ye-Bamlanivimab inokubangela ezinye iziphumo ebezingalindelekanga. Biza ugqirha wakho ukuba unayo nayiphi na ingxaki engaqhelekanga ngelixa ufumana eliyeza.

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 lonke ixesha lokudibana nogqirha wakho.

Buza usokhemesti wakho nayiphi na imibuzo onayo malunga nenaliti ye-bamlanivimab.

Kuya kufuneka uqhubeke nokuzahlula ngokokuyalelwa ngugqirha wakho kwaye ulandele iinkqubo zempilo zikawonkewonke ezinje ngokunxiba imaski, ukudideka ekuhlaleni, kunye nokuhlamba izandla rhoqo.

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.

Umbutho waseMelika woNyango lwezeMpilo-i-Pharmacists, Inc.mele ukuba olu lwazi malunga ne-bamlanivimab lwenziwa ngomgangatho ofanelekileyo wokhathalelo, kwaye ngokuhambelana nemigangatho yobungcali ebaleni. Abafundi bayalumkiswa ukuba i-bamlanivimab ayilulo unyango oluvunyiweyo lwe-coronavirus isifo se-2019 (i-COVID-19) ebangelwa yi-SARS-CoV-2, kodwa endaweni yoko, kusaphandwa ngayo kwaye kungokunje iyafumaneka phantsi, isigunyaziso sokusetyenziswa okungxamisekileyo kwe-FDA (i-EUA) Unyango lwe-COVID-19 ethambileyo ukuya kumodareyitha kwizigulana ezithile. Umbutho waseMelika woNyango lwezeMpilo-iiNkqubo zooSokhemisti, Inc. ayenzi bume okanye ziqinisekiso, zichaza okanye zichaziweyo, kubandakanya, kodwa kungaphelelanga apho, nakweyiphi na iwaranti echaziweyo yokurhweba kunye / okanye ukufaneleka kwinjongo ethile, ngokubhekisele kulwazi, ngakumbi iyazichaza zonke ezi ziqinisekiso. Abafundi bolwazi malunga ne-bamlanivimab bayacetyiswa ukuba i-ASHP ayinaxanduva lwemali eqhubekayo yolwazi, ngazo naziphi na iimpazamo okanye ukushiywa, kunye / okanye naziphi na iziphumo ezivela ekusetyenzisweni kolwazi. Abafundi bayacetyiswa ukuba izigqibo ngokubhekisele kunyango lweziyobisi zizigqibo ezintsonkothileyo zonyango ezifuna isigqibo esizimeleyo, esichaziweyo sengcali efanelekileyo yokhathalelo lwempilo, kwaye ulwazi oluqulethwe kolu lwazi lubonelelwa ngeenjongo zolwazi kuphela. I-American Society ye-Health-System Pharmacists, Inc. ayikhuthazi okanye icebise ukusetyenziswa kwalo naliphi na ichiza. Olu lwazi malunga ne-bamlanivimab aluqwalaselwe njengengcebiso yesigulana. Ngenxa yokutshintsha kolwazi lweziyobisi, uyacetyiswa ukuba ubonane nogqirha wakho okanye usokhemesti malunga nokusetyenziswa kweeklinikhi ezithile kunye nawo onke amayeza.

• nanye