Inaliti ye-Eculizumab

Umxholo

• Ngaphambi kokufumana inaliti ye-eculizumab,
• Inaliti ye-Eculizumab 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 kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko okanye ufumane unyango olungxamisekileyo:

Ukufumana inaliti ye-eculizumab kunokunyusa umngcipheko wokuba uphuhlise usulelo lwe-meningococcal (usulelo olunokuthi luchaphazele ukogquma kwengqondo kunye nentambo yomqolo kunye / okanye lusasazeke kwigazi) ngexesha lonyango lwakho okanye ixesha elithile emva koko. Usulelo lwe-Meningococcal lungabangela ukufa ngexesha elifutshane. Uya kudinga ukufumana isitofu sokuthintela i-meningococcal ubuncinci iiveki ezi-2 ngaphambi kokuba uqale unyango lwakho ngenaliti ye-eculizumab ukunciphisa umngcipheko wokuba uphuhlise 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-eculizumab ngoko nangoko, uyakufumana isitofu sokugonya se-meningococcal ngokukhawuleza.

Nangona ufumana isitofu sokugonya se-meningococcal, kusekho umngcipheko wokuba uhlakulele isifo se-meningococcal ngexesha okanye emva konyango lwakho ngenaliti ye-eculizumab. 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; Umkhuhlane we-103 ° F (39.4 ° C) okanye ngaphezulu; 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-eculizumab. Ugqirha wakho akazukukunika inaliti ye-eculizumab 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 ezi-3 emva konyango lwakho. Bonisa ikhadi kubo bonke ababoneleli ngeenkonzo zonyango abakunyangayo ukuze bazi ngomngcipheko wakho.

Inkqubo ebizwa ngokuba yiSoliris REMS isetelwe ukunciphisa umngcipheko wokufumana inaliti ye-eculizumab. Unokufumana kuphela inaliti ye-eculizumab kugqirha obhalise kule nkqubo, uthethile nawe malunga nemingcipheko yesifo se-meningococcal, ukunike ikhadi lokhuseleko lwesigulana, kwaye uqinisekisile ukuba ufumene isitofu sokugonya i-meningococcal.

Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwesigulana lomenzi (Isikhokelo seyeza) xa uqala unyango ngenaliti ye-eculizumab kwaye ngalo lonke ixesha ufumana inaliti. 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-eculizumab.

Inaliti ye-Eculizumab isetyenziselwa ukunyanga i-paroxysmal nocturnal hemoglobinuria (i-PNH: uhlobo lwe-anemia apho iiseli ezibomvu zegazi ezininzi ziye zaphuka emzimbeni, ngenxa yoko azikho iiseli ezisempilweni ezaneleyo zokuzisa ioksijini kuwo onke amalungu omzimba). Inaliti ye-Eculizumab ikwasetyenziselwa ukunyanga i-atypical hemolytic uremic syndrome (aHUS; imeko ezuzwe njengelifa apho amahlwili egazi amancinci emzimbeni kwaye anokubangela ukonakala kwimithambo yegazi, iiseli zegazi, izintso kunye namanye amalungu omzimba). Inaliti ye-Eculizumab ikwasetyenziselwa ukunyanga uhlobo oluthile lwe-myasthenia gravis (MG; ukuphazamiseka kwenkqubo yemithambo-luvo ebangela ubuthathaka bemisipha). Isetyenziselwa ukunyanga i-neuromyelitis optica spectrum disorder (i-NMOSD; ukuphazamiseka okuzenzekelayo kwenkqubo luvo echaphazela imithambo-luvo yamehlo kunye nentambo yomqolo) kubantu abadala abathile. Inaliti ye-Eculizumab ikwiqela lamayeza abizwa ngokuba ngamachiza omzimba. Isebenza ngokuthintela ukusebenza kwenxalenye yamajoni omzimba anokonakalisa iiseli zegazi kubantu abane-PNH kwaye ebangela ukuba amahlwili enze kubantu abane-AHUS. Ikwasebenza ngokuthintela umsebenzi wenxalenye yamajoni omzimba onokonakalisa iinxalenye ezithile zenkqubo ye-nervous system kubantu abane-NMOSD okanye ngokuphazamisa unxibelelwano phakathi kwemithambo kunye nezihlunu kubantu abane-MG.

Inaliti ye-Eculizumab iza njengesisombululo (ulwelo) ukuze ifakwe ngaphakathi ngaphakathi (emthanjeni) ngaphezulu kwemizuzu engama-35 ngugqirha okanye ngumongikazi kwiofisi yezonyango. Ihlala inikwa abantu abadala kanye ngeveki iiveki ezintlanu kwaye kube kanye ngeveki. Abantwana banokufumana inaliti ye-eculizumab kwishedyuli eyahlukileyo, kuxhomekeke kubudala babo kunye nobunzima bomzimba. Amayeza ongezelelweyo enaliti ye-eculizumab anikwa ngaphambi okanye emva kolunye unyango lwe-PNH, aHUS, MG, okanye i-NMOSD.

Ugqirha wakho uya kukuqala ngedosi esezantsi yenaliti ye-eculizumab kwaye andise idosi yakho emva kweeveki ezi-4.

Inaliti ye-Eculizumab inokubangela ukusabela okunobuzaza. Ugqirha wakho uya kukujonga ngononophelo ngelixa ufumana inaliti ye-eculizumab kunye neyure e-1 emva kokuba ufumene iyeza. Ugqirha wakho unokucothisa okanye ayeke ukufakwa kwakho ukuba unengxaki yokuphendula. Ukuba ufumana naziphi na kwezi mpawu zilandelayo, xelela ugqirha ngoko nangoko: iintlungu esifubeni; ukuziva ndityhafile; irhashalala; imihlathi ukudumba kwamehlo, ubuso, imilebe, ulwimi, okanye umqala; ukudakumba; okanye ubunzima bokuphefumla okanye ukugwinya.

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

Ngaphambi kokufumana inaliti ye-eculizumab,

• xelela ugqirha wakho kunye nosokhemisti ukuba ngaba uxabisa inaliti ye-eculizumab, nawaphi na amanye amayeza, okanye naziphi na izithako kwiinaliti ye-eculizumab 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, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ukhulelwa ngelixa ufumana inaliti ye-eculizumab, tsalela ugqirha wakho.
• ukuba umntwana wakho uza kunyangwa ngenaliti ye-eculizumab, umntwana wakho kufuneka agonyelwe iStreptococcus pneumoniae kunye neHaemophilus influenza yohlobo b (Hib) ngaphambi kokuqala unyango. Thetha nogqirha womntwana wakho malunga nokunika umntwana wakho ezi zitofu zokugonya kunye nolunye ugonyo olufunwa ngumntwana wakho.
• ukuba unyangwa i-PNH, kuya kufuneka uyazi ukuba imeko yakho inokubangela ukuba iiseli ezibomvu zegazi ziyekelele emva kokuba uyekile ukufumana inaliti ye-eculizumab. Ugqirha wakho uya kukujonga ngononophelo kwaye angayalela iimvavanyo zaselebhu kwiiveki zokuqala ezi-8 emva kokuba ulugqibile unyango lwakho. Biza ugqirha wakho ngoko nangoko ukuba ukhula kwezi mpawu zilandelayo: ukudideka, iintlungu esifubeni, ukuphefumla nzima, okanye naziphi na ezinye iimpawu ezingaqhelekanga.
• ukuba unyangwa i-AHUS, kuya kufuneka uyazi ukuba imeko yakho inokubangela ukuba amahlwili egazi enze emzimbeni wakho emva kokuba uyekile ukufumana inaliti ye-eculizumab. Ugqirha wakho uya kukujonga ngononophelo kwaye angayalela iimvavanyo zaselebhu kwiiveki zokuqala ezili-12 emva kokuba ulugqibile unyango lwakho. Fowunela ugqirha wakho ngoko nangoko ukuba uvelisa naziphi na kwezi mpawu: ngesiquphe unengxaki yokuthetha okanye intetho eqondayo; ukudideka; ubuthathaka ngequbuliso okanye ukuba ndindisholo kwengalo okanye umlenze (ngakumbi kwicala elinye lomzimba) okanye kobuso; inkathazo yokuhamba ngesiquphe, isiyezi, ukuphulukana nokulingana okanye ukulungelelanisa; isiqaqa; ukuxhuzula; iintlungu zesifuba; ubunzima bokuphefumla; ukudumba ezingalweni okanye emilenzeni; okanye naziphi na ezinye iimpawu ezingaqhelekanga.

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

Ukuba uphoswa ukuqeshwa ukuze ufumane idosi yenaliti ye-eculizumab, tsalela ugqirha kwangoko.

Inaliti ye-Eculizumab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

• intloko ebuhlungu
• impumlo enemifinya
• intlungu okanye ukudumba empumlweni nasemqaleni
• ukukhohlela
• ubunzima bokulala okanye ukulala
• ukudinwa kakhulu
• isiyezi
• intlungu yesihlunu okanye edibeneyo
• umqolo obuhlungu
• iintlungu ezingalweni okanye emilenzeni
• izilonda emlonyeni
• urhudo
• isicaphucaphu
• ukugabha
• isisu esibuhlungu
• ukuchama kabuhlungu okanye kunzima

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko okanye ufumane unyango olungxamisekileyo:

• ifiva
• ukudumba kweengalo, izandla, iinyawo, amaqatha okanye imilenze esezantsi
• ukubetha kwentliziyo ngokukhawuleza
• ubuthathaka
• ulusu oluthuthu
• ukuqhawukelwa ngumphefumlo

Inaliti ye-Eculizumab 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 zebhu ukujonga impendulo yomzimba wakho kwisitofu se-eculizumab.

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

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.

• Soliris^®