Inaliti ye-infliximab

Umxholo

• Iimveliso zenaliti ye-infliximab zisetyenziselwa ukunciphisa iimpawu zokuphazamiseka komzimba (iimeko apho amajoni omzimba ahlasela amalungu asempilweni kwaye abangela iintlungu, ukudumba kunye nomonakalo) kubandakanya:
• Ngaphambi kokusebenzisa imveliso yenaliti ye-infliximab,
• Imveliso yenaliti ye-infliximab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:
• Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ezi mpawu zilandelayo aziqhelekanga, kodwa ukuba ufumana enye yazo, okanye ezo zidweliswe KULUMKISEKO OBALULEKILEYO okanye kumacandelo okulumkisa awodwa, tsalela umnxeba kwangoko:

Inaliti ye-infliximab, inaliti ye-infliximab-dyyb, kunye ne-infliximab-abda inaliti ngamayeza e-biologic (amayeza enziwe kwizinto eziphilayo). Inaliti ye-Biosimilar infliximab-dyyb kunye ne-infliximab-abda inaliti ifana kakhulu nenaliti ye-infliximab kwaye isebenza ngendlela efanayo nenaliti ye-infliximab emzimbeni. Ke ngoko, igama elithi infliximab injection products liza kusetyenziswa ukumela la mayeza kule ngxoxo.

Iimveliso zenaliti ye-infliximab zinokunciphisa amandla akho okulwa usulelo kwaye zonyuse umngcipheko wokuba ufumane usulelo olubi, kubandakanya isifo esibi, intsholongwane, okanye usulelo olunokuthi lusasazeke emzimbeni wonke. Ezi zifo zingafuna ukunyangwa esibhedlele kwaye zingabangela ukufa. Tshela ugqirha wakho ukuba uhlala ufumana naluphi na uhlobo losulelo okanye ukuba ucinga ukuba unalo naluphi na uhlobo losulelo ngoku. Oku kubandakanya usulelo oluncinci (njengokusikwa okuvulekileyo okanye izilonda), usulelo olufikayo (olufana nezilonda ezibandayo) kunye nosulelo olungapheliyo olungapheliyo. Xelela ugqirha wakho ukuba unesifo seswekile okanye nayiphi na imeko echaphazela amajoni akho omzimba kwaye ukuba uhlala okanye wakha waphila kwiindawo ezinje nge-Ohio okanye iMississippi yomfula apho isifo sokungunda siqhelekile. Buza ugqirha wakho ukuba awazi ukuba ngaba izifo zixhaphake kakhulu kwindawo yakho. Xelela ugqirha wakho ukuba uthatha amayeza anciphisa umsebenzi wamajoni omzimba afana ne-abatacept (Orencia); anakinra (iKineret); imethotrexate (Otrexup, Rasuvo, Trexall, Xatmep); ii-steroids ezinje nge-dexamethasone, methylprednisolone (Medrol), prednisolone (Orapred ODT, Pediapred, Prelone), okanye prednisone; okanye tocilizumab (Actemra).

Ugqirha wakho uya kukujonga esosulelweni ngexesha nasemva konyango lwakho. Ukuba unazo naziphi na kwezi mpawu zilandelayo ngaphambi kokuba uqale unyango lwakho okanye ukuba unazo naziphi na kwezi mpawu zilandelayo ngexesha okanye emva nje konyango lwakho, tsalela umnxeba kwangoko kugqirha: ubuthathaka; ukubila; ubunzima bokuphefumla; umqala obuhkungu; ukukhohlela; ukukhohlela umchamo wegazi; ifiva; ukudinwa kakhulu; iimpawu ezifana nomkhuhlane; ulusu olufudumeleyo, olubomvu, okanye olubuhlungu; urhudo; isisu esibuhlungu; okanye ezinye iimpawu zosulelo.

Unokosulelwa sisifo sephepha (i-TB, isifo esosulelayo semiphunga) okanye i-hepatitis B (intsholongwane echaphazela isibindi) kodwa ungabi nazimpawu zesifo. Kule meko, iimveliso zenaliti ye-infliximab zinokunyusa umngcipheko wokuba usulelo lwakho lube lubi kakhulu kwaye uya kuba neempawu. Ugqirha wakho uza kwenza uvavanyo lolusu ukuze abone ukuba unesifo se-TB esingasebenziyo kwaye angayalela ukuba kwenziwe uvavanyo lwegazi ukuze abone ukuba unesifo se-hepatitis B esingasebenziyo. Ukuba kunyanzelekile, ugqirha wakho uya kukunika amayeza ukunyanga olu sulelo ngaphambi kokuba uqale usebenzise imveliso yenaliti ye-infliximab. Xelela ugqirha wakho ukuba ukhe wakha okanye wakha wanayo na i-TB, ukuba ngaba wakhe wahlala okanye watyelela indawo apho ixhaphake kakhulu i-TB, okanye ukuba ukhe wakufutshane nomntu one-TB. Ukuba unazo naziphi na kwezi mpawu zilandelayo ze-TB, okanye ukuba uvela kwezi mpawu ngexesha lonyango lwakho, tsalela umnxeba kwangoko: ukukhohlela, ukwehla kobunzima, ukulahleka kwethoni yezihlunu, umkhuhlane okanye ukubila ebusuku. Biza ugqirha wakho ngokukhawuleza ukuba unayo nayiphi na le mpawu yesifo sokudumba kwesibindi kohlobo B okanye ukuba ukhula kwezi mpawu ngexesha okanye emva konyango lwakho: ukudinwa kakhulu, ukuba tyheli kolusu okanye amehlo, ukungabi namdla, isicaphucaphu okanye ukugabha, iintlungu zemisipha, umchamo omnyama, intshukumo yombala wodongwe, umkhuhlane, ukugodola, iintlungu zesisu, okanye irhashalala.

Abanye abantwana, abakwishumi elivisayo, kunye nabantu abadala abancinci abafumene imveliso yenaliti ye-infliximab okanye amayeza afanayo bakhulisa umhlaza onobungozi okanye osongela ubomi kubandakanya i-lymphoma (umhlaza oqala kwiiseli ezilwa nosulelo). Abanye abantu abakwishumi elivisayo nabaselula abathathe imveliso ye-infliximab okanye amayeza afanayo bakhulisa i-hepatosplenic T-cell lymphoma (HSTCL), uhlobo olubi kakhulu lomhlaza oluhlala lubangela ukufa ngexesha elifutshane.Uninzi lwabantu abaphuhlise i-HSTCL babephathwa sisifo sikaCrohn (imeko apho umzimba uhlasela ubume bendlela yokugaya, ebangela iintlungu, urhudo, ukwehla kobunzima, kunye nomkhuhlane) okanye ulcerative colitis (imeko ebangela ukudumba kunye nezilonda. kumngxunya wekholoni [amathumbu amakhulu] kunye ne-rectum) ngemveliso yenaliti ye-infliximab okanye iyeza elifanayo kunye nelinye iyeza elibizwa ngokuba yi-azathioprine (Azasan, Imuran) okanye 6-mercaptopurine (Purinethol, Purixan). Xelela ugqirha womntwana wakho ukuba umntwana wakho wakha wanalo naluphi na uhlobo lomhlaza. Ukuba umntwana wakho uvela kwezi mpawu ngexesha lonyango, biza ugqirha ngokukhawuleza: ukuncipha kobunzima obungachazwanga; amadlala adumbayo entanyeni, phantsi kwempuphu, okanye kumphimbo; okanye ukugruzuka okulula okanye ukopha. Thetha nogqirha womntwana wakho malunga neengozi zokunika imveliso yenaliti ye-infliximab kumntwana wakho.

Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwesigulana lomenzi (Isikhokelo seyeza) xa uqala unyango ngemveliso yenaliti ye-infliximab kwaye ngalo lonke ixesha ufumana iyeza. 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 nomngcipheko wokusebenzisa imveliso yenaliti ye-infliximab.

Iimveliso zenaliti ye-infliximab zisetyenziselwa ukunciphisa iimpawu zokuphazamiseka komzimba (iimeko apho amajoni omzimba ahlasela amalungu asempilweni kwaye abangela iintlungu, ukudumba kunye nomonakalo) kubandakanya:

• i-rheumatoid arthritis (imeko apho umzimba uhlasela amalungu ayo, ubangela iintlungu, ukudumba, kunye nokuphulukana nokusebenza) okunyangwa nge-methotrexate (Rheumatrex, Trexall),
• Isifo sikaCrohn (imeko apho umzimba uhlasela ulwelwesi lwendlela yokugaya, ebangela iintlungu, urhudo, ukwehla kobunzima, kunye nomkhuhlane) kubantu abadala nakubantwana abaneminyaka emi-6 ubudala nangaphezulu engakhange iphuculwe xa inyangwa ngamanye amayeza,
• ulcerative colitis (imeko ebangela ukudumba kunye nezilonda kumngxunya wamathumbu amakhulu) kubantu abadala nakubantwana abaneminyaka emi-6 ubudala nangaphezulu engakhange iphuculwe xa inyangwa namanye amayeza,
• i-ankylosing spondylitis (imeko apho umzimba uhlasela amalungu omqolo kunye nezinye iindawo ezibangela iintlungu kunye nomonakalo odibeneyo),
• I-plaque psoriasis (isifo solusu apho umbala obomvu, onamaxolo wenza iindawo ezithile zomzimba) kubantu abadala xa olunye unyango lungafanelekanga,
• kunye ne-psoriatic arthritis (imeko ebangela iintlungu ngokudibeneyo kunye nokudumba kunye nezikali kulusu).

Iimveliso zenaliti ye-infliximab zikudidi lwamayeza abizwa ngokuba yi-tumor necrosis factor-alpha (TNF-alpha) inhibitors. Basebenza ngokuthintela isenzo se-TNF-alpha, into esemzimbeni ebangela ukudumba.

Iimveliso zenaliti ye-infliximab ziza njengomgubo wokuxutywa namanzi angenazintsholongwane kwaye zilawulwe ngaphakathi (emthanjeni) ngugqirha okanye ngumongikazi. Ihlala inikwa kwiofisi kagqirha kanye kwiiveki ezi-2 ukuya kwezi-8, rhoqo ekuqaleni konyango lwakho kwaye kunqabile njengoko unyango lwakho luqhubeka. Kuya kuthatha malunga neeyure ezi-2 ukuba ufumane idosi yakho yonke ye-infliximab, imveliso yenaliti.

Imveliso yenaliti ye-infliximab inokubangela iimpembelelo ezimbi, kubandakanya ukusabela okungafunekiyo ngexesha lokufakwa kunye neeyure ezi-2 emva koko. Ugqirha okanye umongikazi uya kukujonga ngeli xesha ukuze aqiniseke ukuba awunampendulo imbi kunyango. Unokunikwa amanye amayeza ukunyanga okanye ukuthintela ukusabela kwimveliso yenaliti ye-infliximab. Xelela ugqirha wakho okanye umongikazi kwangoko ukuba unazo naziphi na kwezi mpawu zilandelayo ngexesha okanye kungekudala emva kokufakwa kwakho: irhashalala; ukurhawuzelela; ukudumba kobuso, amehlo, umlomo, umqala, ulwimi, imilebe, izandla, iinyawo, amaqatha okanye imilenze esezantsi; ubunzima bokuphefumla okanye ukugwinya; ukugungxula; isiyezi; isiqaqa; ifiva; Ukugodola; ukuxhuzula; ukulahleka kombono; nentlungu esifubeni.

Iimveliso zenaliti ye-infliximab zinokunceda ukulawula iimpawu zakho, kodwa aziyi kuyinyanga imeko yakho. Ugqirha wakho uyakukujonga ngononophelo ukuze ubone ukuba zisebenza kakuhle kangakanani iimveliso zenaliti ye-infliximab. Ukuba unesifo samathambo okanye isifo sikaCrohn, ugqirha wakho unokunyusa inani lamayeza owafumanayo, xa kufuneka njalo. Ukuba unesifo sikaCrohn kwaye imeko yakho ayiphuculanga emva kweeveki ezili-14, ugqirha wakho angayeka ukukuphatha ngemveliso yenaliti ye-infliximab. Kubalulekile ukuxelela ugqirha wakho ukuba uziva njani ngexesha lonyango lwakho.

Iimveliso zenaliti ye-infliximab ngamanye amaxesha zisetyenziselwa ukunyanga isifo sika-Behcet's (izilonda ezisemlonyeni nasemalungwini esini kunye nokudumba kwamalungu ahlukeneyo omzimba). Thetha nogqirha wakho malunga neengozi zokusebenzisa la mayeza kwimeko yakho.

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

Ngaphambi kokusebenzisa imveliso yenaliti ye-infliximab,

• xelela ugqirha wakho kunye nosokhemesti ukuba ngaba uxabisa i-infliximab, infliximab-axxq, infliximab-dyyb, infliximab-abda, nawaphi na amayeza enziwe ngeeprotheyini ze-murine (imouse), nawaphi na amanye amayeza, okanye naziphi na izithako kwi-infliximab, infliximab-dyyb, okanye inaliti ye-infliximab-abda. Buza ugqirha wakho okanye usokhemesti ukuba awuyazi nokuba iyeza olichasayo liyenziwe kwiiproteni ze-murine. 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. Qiniseka ngokukhankanya amayeza adweliswe kwicandelo LESILUMKISO ESIBALULEKILEYO kunye nayo nayiphi na kwezi zinto zilandelayo: ii-anticoagulants (igazi elincinci) njenge-warfarin (Coumadin), i-cyclosporine (Gengraf, Neoral, Sandimmune), kunye ne-theophylline (Elixophyllin, Theo-24, Theochron) . Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga.
• xelela ugqirha wakho ukuba ukhe wasilela kwentliziyo (imeko apho intliziyo ingakwazi ukumpompa igazi elaneleyo kwamanye amalungu omzimba). Ugqirha wakho unokukuxelela ukuba ungasebenzisi imveliso yenaliti ye-infliximab.
• xelela ugqirha wakho ukuba wakhe waphathwa nge-phototherapy (unyango lwe-psoriasis olubandakanya ukuveza ulusu ekukhanyeni kwe-ultraviolet) kwaye ukuba unesifo esichaphazela inkqubo yakho ye-nervous, njenge-multiple sclerosis (MS; ukulungelelanisa, ubuthathaka, kunye nokuba ndindisholo ngenxa yomonakalo wemithambo-luvo), isifo sikaGuillain-Barre (ubuthathaka, ukurhawuzelela, kunye nokukhubazeka okunokwenzeka ngenxa yomonakalo wemithambo-luvo ngesiquphe) okanye i-optic neuritis (ukudumba kwemithambo-luvo ethumela imiyalezo ukusuka esweni iye kwingqondo); ukuba ndindisholo, ukutshisa okanye ukurhawuzelela nakweliphi na ilungu lomzimba wakho; ukuxhuzula; isifo esinganyangekiyo semiphunga (COPD; iqela lezifo ezichaphazela imiphunga kunye neendlela zomoya); naluphi na uhlobo lomhlaza; iingxaki zokopha okanye izifo ezichaphazela igazi lakho; okanye isifo sentliziyo.
• xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ukhulelwa ngelixa usebenzisa imveliso yenaliti ye-infliximab, tsalela ugqirha wakho. Ukuba usebenzisa imveliso yenaliti ye-infliximab ngexesha lokukhulelwa kwakho, qiniseka ukuba uthethe nogqirha womntwana wakho malunga noku emva kokuba umntwana wakho ezelwe. Umntwana wakho kusenokufuneka afumane ugonyo oluthile kamva kunesiqhelo.
• ukuba wenza utyando, kubandakanya utyando lwamazinyo, xelela ugqirha okanye ugqirha wamazinyo ukuba usebenzisa imveliso yenaliti ye-infliximab.
• xelela ugqirha wakho ukuba usandula ukufumana isitofu sokugonya. Phinda ujonge nogqirha wakho ukuze ubone ukuba ufuna ukufumana naluphi na ugonyo. Awunalo ugonyo ngaphandle kokuthetha nogqirha wakho. Kubalulekile ukuba abantu abadala kunye nabantwana bafumane zonke izitofu ezifanelekileyo zokugonya ngaphambi kokuqala unyango nge-infliximab.
• Kuya kufuneka uyazi ukuba unokulibaziseka ukusabela okungafunekiyo kwiintsuku ezi-3 ukuya kwezi-12 emva kokufumana imveliso yenaliti ye-infliximab. Xelela ugqirha wakho ukuba unazo naziphi na kwezi mpawu zilandelayo kwiintsuku ezininzi okanye ngaphezulu emva konyango lwakho: izihlunu okanye iintlungu ezidibeneyo; ifiva; irhashalala; imihlathi ukurhawuzelela; ukudumba kwezandla, ubuso, okanye imilebe; ubunzima bokugwinya; umqala obuhkungu; kunye nentloko.

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

Imveliso yenaliti ye-infliximab inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

• isicaphucaphu
• isilungulela
• intloko ebuhlungu
• impumlo enemifinya
• amabala amhlophe emlonyeni
• ukurhawuzelelwa kwilungu lobufazi, ukutshisa, kunye nentlungu, okanye eminye imiqondiso yosulelo lwegwele
• ukugungxula

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ezi mpawu zilandelayo aziqhelekanga, kodwa ukuba ufumana enye yazo, okanye ezo zidweliswe KULUMKISEKO OBALULEKILEYO okanye kumacandelo okulumkisa awodwa, tsalela umnxeba kwangoko:

• Naluphi na uhlobo lokuqubha, kubandakanya irhashalala ezidleleni okanye ezingalweni eziya zisiba mbi elangeni
• iintlungu zesifuba
• ukubetha kwentliziyo ngokungaqhelekanga
• iintlungu ezingalweni, emqolo, entanyeni, okanye emhlathini
• isisu esibuhlungu
• ukudumba kweenyawo, amaqatha, isisu, okanye imilenze esezantsi
• ukukhawuleza ukutyeba
• ukuqhawukelwa ngumphefumlo
• ukungaboni kakuhle okanye utshintsho lombono
• ubuthathaka ngequbuliso bengalo okanye umlenze (ngakumbi kwelinye icala lomzimba) okanye kobuso
• intlungu yesihlunu okanye edibeneyo
• ukuba ndindisholo okanye ukurhawuzelela nakweliphi na ilungu lomzimba
• ukudideka ngesiquphe, ingxaki yokuthetha, okanye ingxaki yokuqonda
• ukuhamba ngesiquphe
• isiyezi okanye ukudinwa
• ukulahleka kwemali eseleyo okanye yokulungelelanisa
• ngequbuliso, intloko ebuhlungu
• ukuxhuzula
• mthubi ulusu okanye amehlo
• umchamo omnyama ngombala
• Ukuphelelwa ngumdla wokutya
• iintlungu kwinxalenye ephezulu yesisu
• ukugruzuka okanye ukopha okungaqhelekanga
• igazi esitulweni
• ulusu oluthuthu
• bomvu, amabala anamaxolo okanye amaqhuma agcwele ulusu kulusu

Inaliti ye-infliximab inokunyusa umngcipheko wokuba ne-lymphoma (umhlaza oqala kwiiseli ezilwa nosulelo) kunye neminye imihlaza, thetha nogqirha wakho malunga nemingcipheko yokufumana imveliso yenaliti ye-infliximab.

Imveliso yenaliti ye-infliximab 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).

Ugqirha wakho uya kugcina amayeza eofisini yakhe.

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 unokuyalela iimvavanyo ezithile zaselebhu ukujonga impendulo yomzimba wakho kwimveliso yenaliti ye-infliximab.

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.

• Avsola^® (I-infliximab-axxq)
• Ukungenisa^® (I-infliximab-dyyb)
• Yiza kwakhona^® (Infliximab)
• Ukuhlaziywa kwakhona^® (Infliximab-abda)

• I-anti-tumor Necrosis Factor-alpha
• Ulwaphulo lwe-TNF-alpha
• cA2