Inaliti yeRavulizumab-cwvz

Umxholo

• Phambi kokufumana inaliti ye-ravulizumab-cwvz,
• IRavulizumab-cwvz 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 zidweliswe KWISILUMKISO ESIBALULEKILEYO okanye INDLELA yamacandelo, tsalela ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

Ukufumana inaliti ye-ravulizumab-cwvz kunokunyusa umngcipheko wokuba ube nosulelo lwe-meningococcal (usulelo olunokuchaphazela ukogquma kwengqondo kunye nentambo yomqolo kunye / okanye lusasazeke kwigazi) ngexesha lonyango lwakho okanye kangangexesha elithile emva koko. Usulelo lwe-Meningococcal lungabangela ukufa ngexesha elifutshane. Kuya kufuneka ufumane isitofu sokuthintela i-meningococcal ubuncinci kwiiveki ezi-2 ngaphambi kokuba uqale unyango lwakho ngenaliti ye-ravulizumab-cwvz ukunciphisa umngcipheko wokuba uza kuluvela olu hlobo losulelo. Ukuba sele ufumene olu gonyo ngaphambili, kungafuneka ufumane idosi yokunyusa ngaphambi kokuba uqale unyango lwakho. Ukuba ugqirha wakho uziva ukuba kufuneka uqale unyango ngenaliti ye-ravulizumab-cwvz ngoko nangoko, uyakufumana isitofu sakho sokugonya se-meningococcal ngokukhawuleza kwaye uthathe isibulala-zintsholongwane iiveki ezimbini.

Nangona ufumana isitofu sokugonya se-meningococcal, kusekho umngcipheko wokuba uhlakulele isifo se-meningococcal ngexesha okanye emva konyango lwakho ngenaliti ye-ravulizumab-cwvz. Ukuba unazo naziphi na kwezi mpawu zilandelayo, tsalela umnxeba kwangoko okanye ufumane uncedo lonyango olungxamisekileyo: intloko ebuhlungu eza kunye nesicaphucaphu okanye ukugabha, umkhuhlane, intamo elukhuni, okanye umqolo oqinileyo; ifiva; irhashalala kunye nefiva; ukudideka; iintlungu zemisipha kunye nezinye iimpawu ezinje ngomkhuhlane; okanye ukuba amehlo akho anomdla ekukhanyeni.

Tshela ugqirha wakho ukuba unefiva okanye ezinye iimpawu zosulelo ngaphambi kokuba uqale unyango lwakho ngenaliti ye-ravulizumab-cwvz. Ugqirha wakho akazukukunika inaliti ye-ravulizumab-cwvz ukuba sele unesifo se-meningococcal.

Ugqirha wakho uya kukunika ikhadi lokhuseleko lesigulana esinolwazi malunga nomngcipheko wokuba nesifo se-meningococcal ngexesha okanye kangangexesha elithile emva konyango lwakho. Phatha eli khadi ngamaxesha onke xa unyangwa kunye neenyanga ezisi-8 emva konyango lwakho. Bonisa ikhadi kubo bonke ababoneleli ngeenkonzo zonyango abakunyangayo ukuze bazi ngomngcipheko wakho.

Inkqubo ebizwa ngokuba yi-Ultomiris REMS isetelwe ukunciphisa umngcipheko wokufumana inaliti ye-ravulizumab-cwvz. Unokufumana kuphela inaliti ye-ravulizumab-cwvz kugqirha obhalise kule nkqubo, uthethe nawe malunga neengozi zesifo se-meningococcal, wakunika ikhadi lokhuseleko lesigulana, kwaye waqinisekisa ukuba ufumene isitofu sokugonya i-meningococcal.

Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwesigulana lomenzi (Isikhokelo seyeza) xa uqala unyango nge-ravulizumab-cwvz kwaye ngalo lonke ixesha uzalisa 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.

Thetha nogqirha wakho malunga nemingcipheko yokufumana inaliti ye-ravulizumab-cwvz.

Inaliti ye-Ravulizumab-cwvz isetyenziselwa abantu abadala ukunyanga i-paroxysmal nocturnal hemoglobinuria (PNH: uhlobo lwe-anemia apho iiseli ezibomvu zegazi ziye zaphuka emzimbeni, ngenxa yoko azikho iiseli ezisempilweni ezaneleyo zokuzisa ioksijini kuwo onke amalungu omzimba ). Inaliti yeRavulizumab-cwvz ikwasetyenziswa kubantu abadala nakubantwana kwinyanga eyi-1 ubudala nangaphezulu ukunyanga isifo se-hemolytic uremic syndrome (aHUS; imeko ezuzwe njengelifa apho amahlwili egazi amancinci emzimbeni kwaye anokubangela umonakalo kwimithambo yegazi, iiseli zegazi, izintso, namanye amalungu omzimba). URavulizumab-cwvz ukwiklasi yamayeza abizwa ngokuba ngamachiza omzimba. Isebenza ngokuthintela ukusebenza kwenxalenye yamajoni omzimba anokonakalisa iiseli zegazi kubantu abane-PNH kwaye ebangela ukuba amahlwili enze kubantu abane-AHUS.

Inaliti yeRavulizumab-cwvz iza njengesisombululo (ulwelo) esiza kufakwa ngaphakathi ngaphakathi emthanjeni (emthanjeni) ngaphezulu kweeyure eziyi-2-4 ngugqirha okanye ngumongikazi kwiofisi yezonyango. Ihlala inikwa iiveki ezisi-8 ukuqala kwiiveki ezi-2 emva kwedosi yakho yokuqala. Abantwana banokufumana inaliti ye-ravulizumab-cwvz rhoqo kwiiveki ezi-4 okanye ezisi-8, kuxhomekeke kubunzima bomzimba wabo, ukuqala kwiiveki ezi-2 emva kwethamo lokuqala.

Inaliti yeRavulizumab-cwvz inokubangela ukusabela okungalunganga. Ugqirha wakho uya kukujonga ngononophelo ngelixa ufumana inaliti ye-ravulizumab-cwvz kunye neyure e-1 emva kokuba ufumene amayeza. Ugqirha wakho unokucothisa okanye ayeke ukufakwa kwakho ukuba unengxaki yokuphendula. Ukuba ufumana naziphi na kwezi mpawu zilandelayo, xelela ugqirha ngoko nangoko: iintlungu esifubeni; ubunzima bokuphefumla; ukuqhawukelwa ngumphefumlo; ukudumba kobuso bakho, ulwimi, okanye umqala; iintlungu ezisezantsi; iintlungu kunye nokufakwa; okanye ndiziva ndidiniwe.

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

Phambi kokufumana inaliti ye-ravulizumab-cwvz,

• xelela ugqirha wakho kunye nosokhemesti ukuba ngaba uxabana ne-ravulizumab-cwvz, nawaphi na amanye amayeza, okanye nasiphi na isithako senaliti ye-ravulizumab-cwvz. Buza usokhemesti wakho okanye ujonge isiKhokelo seyeza ukuze ufumane uluhlu lwezithako.
• xelela ugqirha wakho kunye nosokhemesti ukuba yeyiphi na amayeza kagqirha kunye nalawo angabhaliswanga, 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 ukhe wakha wanazo naziphi na ezinye iimeko zonyango.
• xelela ugqirha wakho ukuba ukhulelwe okanye ucwangcise ukukhulelwa. Ukuba ukhulelwa ngelixa ufumana inaliti ye-ravulizumab-cwvz, tsalela ugqirha wakho.
• xelela ugqirha wakho ukuba uncelisa. Akufanele uncancise ngelixa ufumana i-ravulizumab-cwvz kunye neenyanga ezili-8 emva kwethamo lakho lokugqibela lonyango.
• ukuba unyangwa i-PNH, kuya kufuneka uyazi ukuba imeko yakho inokubangela ukuba iiseli ezibomvu zegazi ezininzi ziyekwe emva kokuba uyekile ukufumana inaliti ye-ravulizumab-cwvz. Ugqirha wakho uya kukujonga ngononophelo kwaye angayalela iimvavanyo zaselebhu ubuncinci iiveki ezili-16 emva kokuba ulugqibile unyango lwakho. Biza ugqirha wakho ngoko nangoko ukuba uvelisa ezi mpawu zilandelayo: ukudinwa kakhulu; igazi kumchamo; isisu esibuhlungu; ubunzima bokugwinya; ukungakwazi ukufumana okanye ukugcina ulwakhiwo; ukuqhawukelwa ngumphefumlo; iintlungu, ukudumba, ukufudumala, ubomvu, okanye ukuthamba kumlenze omnye kuphela; intetho ecothayo okanye enzima; ubuthathaka okanye ukuphazamiseka kwengalo okanye umlenze; okanye naziphi na ezinye iimpawu ezingaqhelekanga.
• ukuba uphathwa nge-AHUS, kuya kufuneka uyazi ukuba imeko yakho inokubangela ukuba amahlwili egazi enze emzimbeni wakho emva kokuba uyekile ukufumana inaliti ye-ravulizumab-cwvz. Ugqirha wakho uya kukujonga ngononophelo kwaye angayalela iimvavanyo zaselebhu ubuncinci iinyanga ezili-12 emva kokuba ulugqibile unyango lwakho. Biza ugqirha wakho ngoko nangoko ukuba uvelisa naziphi na kwezi mpawu: ngesiquphe unengxaki yokuthetha okanye ukuqonda intetho, ukudideka, ukuba buthathaka ngequbuliso okanye ukuba ndindisholo kwengalo okanye umlenze (ngakumbi kwicala elinye lomzimba) okanye ebusweni, ukuhamba ngequbuliso, isiyezi, ukuphulukana nokulingana okanye ukulungelelanisa, ukuphelelwa ngamandla, ukuxhuzula, iintlungu esifubeni, ukuphefumla nzima, okanye naziphi na iimpawu ezingaqhelekanga.

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

Ukuba uphoswa idinga lokufumana idosi ye-ravulizumab-cwvz inaliti, tsalela ugqirha kwangoko.

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

• urhudo
• isicaphucaphu
• ukugabha
• ukuqhina
• intloko ebuhlungu
• intlungu yesihlunu okanye edibeneyo
• iintlungu ezingalweni okanye emilenzeni
• impumlo enemifinya
• intlungu okanye ukudumba empumlweni nasemqaleni
• ukukhohlela
• isiyezi
• ukuchama kabuhlungu okanye kunzima
• ukulahleka kweenwele
• isikhumba esomileyo
• ukunciphisa ukutya
• ukudinwa

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe KWISILUMKISO ESIBALULEKILEYO okanye INDLELA yamacandelo, tsalela ugqirha ngokukhawuleza okanye ufumane unyango olungxamisekileyo:

• umkhuhlane okanye ezinye iimpawu zosulelo
• isisu esibuhlungu

IRavulizumab-cwvz 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).

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 zelebhu ukujonga impendulo yomzimba wakho kwinaliti ye-ravulizumab-cwvz.

Buza usokhemesti wakho ukuba unayo nayiphi na imibuzo onayo malunga nenaliti ye-ravulizumab-cwvz.

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.

• Ultomiris^®