I-Epoetin Alfa, Injection

-Delile

• Ngaphambi kokusebenzisa umkhiqizo we-epoetin alfa injection,
• Imikhiqizo yomjovo we-Epoetin alfa ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nalezi zimpawu ezilandelayo, noma lezo ezibalwe esigabeni ESIBALULEKILE SESEXWAYISO, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:
• Izimpawu zokudlula ngokweqile zingafaka:

Umjovo we-Epoetin alfa nomjovo we-epoetin alfa-epbx yimithi ye-biologic (imithi eyenziwe ngezinto eziphilayo). Umjovo we-Biosimilar epoetin alfa-epbx ufana kakhulu nomjovo we-epoetin alfa futhi usebenza ngendlela efanayo nomjovo we-epoetin alfa emzimbeni. Ngakho-ke, igama elithi imikhiqizo ye-epoetin injection izosetshenziselwa ukumela le mithi kule ngxoxo.

Zonke iziguli:

Ukusebenzisa imikhiqizo yomjovo we-epoetin alfa kwandisa ubungozi bokuthi amahlule egazi akhe noma ahambele emilenzeni, emaphashini, noma ebuchosheni. Tshela udokotela wakho uma uke waba nesifo senhliziyo, isifo sohlangothi, i-venous thrombosis (i-DVT; igazi elihlangana emlenzeni wakho), i-pulmonary embolus (PE; ihlule legazi emaphashini akho), noma uma uzohlinzwa . Ngaphambi kokuhlinzwa, ngisho nokuhlinzwa kwamazinyo, tshela udokotela wakho noma udokotela wamazinyo ukuthi welashwa ngomkhiqizo womjovo we-epoetin alfa, ikakhulukazi uma uhlinzwa ngomthambo we-coronary bypass graft (CABG) noma nge-orthopedic. Udokotela wakho angakunika i-anticoagulant ('blood thinner') ukuvimbela amahlule ukuba akhe ngesikhathi sokuhlinzwa. Shayela udokotela wakho ngokushesha noma uthole usizo oluphuthumayo lwezokwelapha uma uhlangabezana nalezi zimpawu ezilandelayo: ubuhlungu, ubumnene, ubomvu, ukufudumala, kanye / noma ukuvuvukala emilenzeni; ukuphola noma ukuphaphatheka engalweni noma emlenzeni; ukuphefumula kanzima noma ukuphefumula okuncane; ubuhlungu besifuba; inkathazo engazelelwe yokukhuluma noma ukuqonda inkulumo; ukudideka okungazelelwe; ubuthakathaka obungazelelwe noma ukuba ndikindiki kwengalo noma umlenze (ikakhulukazi ohlangothini olulodwa lomzimba) noma kobuso; ukuhamba ngokungazelelwe ukuhamba, isiyezi, noma ukulahlekelwa ibhalansi noma ukuxhumanisa; noma ukuquleka. Uma welashwa nge-hemodialysis (ukwelashwa ukususa udoti egazini lapho izinso zingasebenzi), ihlule legazi lingakheka ekufinyeleleni kwakho kwemithambo (indawo lapho ishubhu le-hemodialysis lixhuma khona emzimbeni wakho). Tshela udokotela wakho uma ukufinyelela kwakho ngemithambo kungasebenzi njengokujwayelekile.

Udokotela wakho uzolungisa umthamo wakho womkhiqizo womjovo we-epoetin alfa ukuze izinga lakho le-hemoglobin (inani lamaprotheni atholakala kumaseli abomvu egazi) liphakeme nje ngokwanele ukuthi awudingi ukumpontshelwa amaseli abomvu egazi (ukudluliswa kwamaseli abomvu egazi lomuntu oyedwa emzimbeni womunye umuntu ukwelashwa ngokweqile) Uma uthola okwanele komkhiqizo we-epoetin alfa ukukhuphula i-hemoglobin yakho iye ezingeni elijwayelekile noma eliseduze, kunengozi enkulu yokuthi uzohlaselwa isifo sohlangothi noma ube nezinkinga zenhliziyo ezinkulu noma ezisongela impilo kubandakanya ukuhlaselwa yinhliziyo noma ukwehluleka kwenhliziyo. Shayela udokotela wakho ngokushesha noma uthole usizo oluphuthumayo lwezokwelapha uma uhlangabezana nalezi zimpawu ezilandelayo: ubuhlungu besifuba, ukucindezela ukucindezela, noma ukuqina; ukuphelelwa umoya; isicanucanu, ikhanda elikhanyayo, ukujuluka, nezinye izimpawu zokuqala zesifo senhliziyo; ukungakhululeki noma ubuhlungu ezingalweni, ehlombe, entanyeni, emihlathini, noma emuva; noma ukuvuvukala kwezandla, izinyawo, noma amaqakala.

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho uzo-oda izivivinyo ezithile zelebhu ukuze ahlole impendulo yomzimba wakho kumikhiqizo yomjovo we-epoetin alfa. Udokotela wakho anganciphisa umthamo wakho noma akutshele ukuthi uyeke ukusebenzisa umjovo we-epoetin alfa isikhathi esithile uma izivivinyo zibonisa ukuthi usengozini enkulu yokuthola imiphumela emibi kakhulu. Landela izinkomba zikadokotela wakho ngokucophelela.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa ngomkhiqizo womjovo we-epoetin alfa futhi isikhathi ngasinye lapho ugcwalisa umuthi wakho. Funda imininingwane ngokucophelela bese ubuza udokotela noma usokhemisi wakho uma unemibuzo. Ungavakashela futhi iwebhusayithi ye-Food and Drug Administration (FDA) (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) noma iwebhusayithi yomkhiqizi ukuthola i-Medication Guide.

Khuluma nodokotela wakho ngezingozi zokusebenzisa umkhiqizo we-epoetin alfa injection.

Iziguli ezinomdlavuza:

Ezifundweni zomtholampilo, abantu abanomdlavuza othile abathole umjovo we-epoetin alfa bafa ngokushesha noma baba nokukhula kwesimila, ukubuya komdlavuza wabo, noma umdlavuza owasabalala ngokushesha kunabantu abangawutholanga umuthi. Kufanele uthole kuphela imikhiqizo yomjovo we-epoetin alfa ukwelapha i-anemia ebangelwa i-chemotherapy uma i-chemotherapy yakho kulindeleke ukuthi iqhubeke okungenani izinyanga ezimbili ngemuva kokuqala ukwelashwa kwakho ngomjovo we-epoetin alfa futhi uma lingekho ithuba lokuthi umdlavuza wakho uzokwelashwa. Ukwelashwa ngemikhiqizo yomjovo we-epoetin alfa kufanele kumiswe lapho inkambo yakho yamakhemikhali iphela.

Iziguli ezihlinzayo:

Unganikezwa umkhiqizo we-epoetin alfa injection ukuze unciphise ubungozi bokuthi uzoba ne-anemia futhi udinge ukumpontshelwa igazi ngenxa yokwehla kwegazi phakathi kwezinhlobo ezithile zokuhlinzwa. Kodwa-ke, ukuthola umkhiqizo womjovo we-epoetin alfa ngaphambi nangemva kokuhlinzwa kungakhuphula ubungozi bokuthi uzoba negazi eliyingozi ngesikhathi sokuhlinzwa noma ngemuva kwaso. Udokotela wakho mhlawumbe uzokunikeza imithi yokusiza ukuvimbela amahlule egazi.

Imikhiqizo yomjovo we-Epoetin alfa isetshenziselwa ukwelapha i-anemia (inani eliphansi kunalelejwayelekile lamaseli abomvu egazi) kubantu abanesifo sezinso esingalapheki (isimo lapho izinso ziyeka ukusebenza unomphela isikhathi eside). Imikhiqizo yomjovo we-Epoetin alfa nayo isetshenziselwa ukwelapha i-anemia ebangelwa ukwelashwa ngamakhemikhali kubantu abanezinhlobo ezithile zomdlavuza noma okubangelwa i-zidovudine (AZT, Retrovir, eTrizivir, eCombivir), umuthi osetshenziselwa ukwelapha igciwane lesandulela-ngculazi (i-HIV). Imikhiqizo yokujova i-Epoetin alfa nayo iyasetshenziswa ngaphambi nangemuva kwezinhlobo ezithile zokuhlinzwa ukwehlisa ithuba lokuthi ukumpontshelwa igazi (ukudluliselwa kwegazi lomuntu oyedwa emzimbeni womunye umuntu) kuzodingeka ngenxa yokopha ngesikhathi sokuhlinzwa. Imikhiqizo yomjovo we-Epoetin alfa akufanele isetshenziselwe ukunciphisa ubungozi bokuthi ukumpontshelwa kuzodingeka kubantu abahlinzwa ezinhliziyweni zabo noma emithanjeni yegazi. Imikhiqizo yokujova i-Epoetin alfa nayo akufanele isetshenziselwe ukwelapha abantu abakwaziyo nabazimisele ukunikela ngegazi ngaphambi kokuhlinzwa ukuze leli gazi lithathelwe indawo emizimbeni yabo ngesikhathi sokuhlinzwa noma ngemuva kwaso. Imikhiqizo yokujova i-Epoetin alfa ayinakusetshenziswa esikhundleni sokufakwa kwegazi elibomvu ukwelapha i-anemia enamandla futhi ayikhonjiswanga ukuthi ithuthukisa ukukhathala noma inhlalakahle engabangelwa yi-anemia. Imikhiqizo ye-epoetin alfa isesigabeni semithi ebizwa ngama-erythropoiesis-stimulating agents (ESAs). Zisebenza ngokubangela umnkantsha (izicubu ezithambile ngaphakathi kwamathambo lapho kwenziwa khona igazi) ukwenza amangqamuzana egazi abomvu amaningi.

Imikhiqizo yomjovo we-Epoetin alfa iza njengesisombululo (uketshezi) ukujova ngomgogodla (ngaphansi kwesikhumba) noma ngemithambo (emthanjeni). Imvamisa ijovwa kanye kuya kathathu ngesonto. Lapho kusetshenziswa imikhiqizo yomjovo we-epoetin alfa ukunciphisa ubungozi bokuthi ukumpontshelwa igazi kuzodingeka ngenxa yokuhlinzwa, kwesinye isikhathi kujovwa kanye ngosuku izinsuku eziyishumi ngaphambi kokuhlinzwa, ngosuku lokuhlinzwa nangezinsuku ezi-4 ngemuva kokuhlinzwa. Ngenye indlela, imikhiqizo yomjovo we-epoetin alfa kwesinye isikhathi iyajova kanye ngesonto, kuqala amasonto ama-3 ngaphambi kokuhlinzwa nangosuku lokuhlinzwa.

Udokotela wakho uzokuqala ngomthamo ophansi womkhiqizo womjovo we-epoetin alfa futhi alungise umthamo wakho kuye ngemiphumela yakho yelabhu nokuthi uzizwa kanjani, imvamisa kungabi ngaphezu kwesisodwa njalo ngenyanga. Udokotela wakho futhi angakutshela ukuthi uyeke ukusebenzisa umkhiqizo womjovo we-epoetin alfa okwesikhashana. Landela le miyalo ngokucophelela.

Imikhiqizo yomjovo we-Epoetin alfa izosiza ukulawula i-anemia yakho inqobo nje uma uqhubeka nokuyisebenzisa. Kungathatha amasonto ama-2-6 noma ngaphezulu ngaphambi kokuba uzwe inzuzo ephelele yomkhiqizo womjovo we-epoetin alfa. Ungayeki ukusebenzisa umkhiqizo we-epoetin alfa ngaphandle kokukhuluma nodokotela wakho.

Imikhiqizo yokujova i-Epoetin alfa inganikezwa udokotela noma umhlengikazi, noma ungatshelwa ukuthi ujove umuthi ekhaya. Uma uzobe ujova umuthi ekhaya, landela izinkomba ezikulebuli kadokotela ngokucophelela bese ucela udokotela noma usokhemisi wakho ukuthi akuchaze nganoma iyiphi ingxenye ongayiqondi. Sebenzisa umkhiqizo we-epoetin alfa injection njengoba uqondisiwe. Ukukusiza ukuthi ukhumbule ukusebenzisa umkhiqizo we-epoetin alfainjection, maka ikhalenda ukugcina umkhondo wokuthi uzowuthola nini umthamo. Ungayisebenzisi ngaphezulu noma ngaphansi kwayo noma uyisebenzise kaningi kunokuyalelwa ngudokotela wakho.

Uma usebenzisa umkhiqizo we-epoetin alfa ekhaya, umhlinzeki wezokunakekelwa kwezempilo uzokukhombisa ukuthi ungawujova kanjani umuthi. Qiniseka ukuthi uyaziqonda lezi zinkomba. Ngaphambi kokusebenzisa i-epoetin alfaproduct okokuqala, wena kanye nomuntu ozonikeza imijovo kufanele nifunde imininingwane yomkhiqizi yesiguli esiza nayo. Buza umhlinzeki wakho wezokunakekelwa kwezempilo uma unemibuzo mayelana nokuthi kufanele uwufake kuphi umuthi emzimbeni wakho, ukuthi ungawufaka kanjani umjovo, hlobo luni lomjovo ozowusebenzisa, noma ukuthi ungazilahla kanjani izinaliti nemijovo esetshenzisiwe ngemuva kokujova umuthi. Ngaso sonke isikhathi gcina isipetu senaliti kanye nenaliti esandleni.

Unganyakazisi umkhiqizo womjovo we-epoetin alfa. Uma unyakazisa umuthi, ungabukeka unogwebu futhi akufanele usetshenziswe.

Ungafaka umjovo we-epoetin alfa ngaphansi kwesikhumba noma yikuphi endaweni engaphandle yezingalo zakho ezingaphezulu, maphakathi namathanga angaphambili, isisu (ngaphandle kwendawo engamasentimitha ama-5 ezungeze inkaba [inkinobho yesisu]) , noma indawo engaphandle yezinqe. Ungafaki umjovo we-epoetin alfa endaweni ethambile, ebomvu, elimele, eqinile, noma enezibazi noma amamaki okwelula. Khetha indawo entsha njalo lapho ufaka umuthi, njengoba uqondiswe ngudokotela wakho.

Uma welashwa nge-dialysis (ukwelashwa ukususa imfucuza egazini lapho izinso zingasebenzi), udokotela wakho angakutshela ukuthi ujove umuthi ethekwini lakho lokungena elinobuthi. Buza udokotela wakho uma unemibuzo mayelana nokuthi ungayijova kanjani imithi yakho.

Njalo bheka isixazululo ngaphambi kokusijova. Qiniseka ukuthi isitsha sibhalwe igama elifanele namandla emithi kanye nosuku lokuphelelwa yisikhathi olungadlulanga. Futhi hlola ukuthi isisombululo sicacile futhi asinambala futhi asiqukethe izigaxa, ama-flakes, noma izinhlayiya. Uma kunezinkinga ngemithi yakho, shayela usokhemisi wakho futhi ungayijovi.

Lo muthi ungabekelwa okunye ukusetshenziswa. Khuluma nodokotela wakho ngezingozi zokusebenzisa lo muthi ngesimo sakho.

Ngaphambi kokusebenzisa umkhiqizo we-epoetin alfa injection,

• Tshela udokotela kanye nosokhemisi wakho uma ungenwe i-epoetin alfa, i-epoetin alfa-epbx, i-darbepoetin alfa (i-Aranesp), noma imuphi omunye umuthi, noma iziphi izithako emikhiqizweni yomjovo we-epoetin alfa. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha 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 uma uke waba nomfutho wegazi ophakeme noma wake waba ne-red cell aplasia (PRCA; uhlobo lwe-anemia enamandla engahle iqhamuke ngemuva kokwelashwa nge-ESA efana ne-darbepoetin alfa injection noma i-epoetin alfa injection).Udokotela wakho angakutshela ukuthi ungasebenzisi umkhiqizo we-epoetin alfa injection.
• utshele udokotela wakho uma uke wahlaselwa yisifo sokuwa noma wake waquleka. Uma usebenzisa i-epoetin alfa injection product ukwelapha i-anemia ebangelwa yisifo sezinso esingalapheki, tshela udokotela wakho uma uke waba nomdlavuza noma wake waba nawo.
• tshela udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uma ukhulelwa ngenkathi usebenzisa umkhiqizo we-epoetin alfa injection, shayela udokotela wakho.
• uma uhlinzwa, kufaka phakathi ukuhlinzwa kwamazinyo, tshela udokotela noma udokotela wamazinyo ukuthi usebenzisa umkhiqizo we-epoetin alfa injection.

Udokotela wakho angakunikeza ukudla okukhethekile ukusiza ukulawula umfutho wegazi lakho nokusiza ukukhuphula amazinga wakho wensimbi ukuze umkhiqizo we-epoetin alfa injection ungasebenza kahle ngangokunokwenzeka. Landela lezi zinkomba ngokucophelela bese ubuza udokotela wakho noma udokotela wezokudla uma unemibuzo.

Shayela udokotela wakho akubuze ukuthi wenzeni uma uphuthelwa umthamo womkhiqizo womjovo we-epoetin. Ungasebenzisi umthamo ophindwe kabili ukwenza okulahlekile.

Imikhiqizo yomjovo we-Epoetin alfa ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ikhanda
• ukuqaqamba kwamalunga noma kwemisipha, ubuhlungu, noma ubuhlungu
• isicanucanu
• ukuhlanza
• ukuncipha komzimba
• izilonda emlonyeni
• ubunzima bokulala noma ukulala
• ukudana
• ukuphazamiseka kwemisipha
• ikhala eligobayo, ukuthimula, nokuminyana
• umkhuhlane, ukukhwehlela, noma ukubanda
• ububomvu, ukuvuvukala, ubuhlungu, noma ukulunywa endaweni yomjovo

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nalezi zimpawu ezilandelayo, noma lezo ezibalwe esigabeni ESIBALULEKILE SESEXWAYISO, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• ukuqubuka
• isifuba
• ukulunywa
• ukuvuvukala kobuso, umphimbo, ulimi, izindebe, noma amehlo
• amabhamuza esikhumba noma isikhumba esihlabayo
• isifuba
• ukuphefumula kanzima noma ukugwinya
• ukukhathala okungavamile
• ukungabi namandla
• isiyezi
• ukuquleka
• isithuthwane

Imikhiqizo yomjovo we-Epoetin alfa ingadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi usebenzisa 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 le mithi esitsheni efike ukuze ivikele ekukhanyeni, ivalwe ngokuqinile, futhi ingafinyeleleki ezinganeni. Gcina i-epoetin alfa ne-epoetin alfa-epbx esiqandisini, kodwa ungayifaki iqhwa. Lahla noma imuphi umuthi okhandisiwe. Lahla isitsha esine-multidose somjovo we-epoetin alfa ezinsukwini ezingama-21 ngemuva kokuwusebenzisa okokuqala.

Kubalulekile ukugcina yonke imishanguzo ingabonakali futhi ifinyeleleke ezinganeni njengoba iziqukathi eziningi (njengezingqondo zamaphilisi zamasonto onke kanye nalawo amaconsi wamehlo, okhilimu, amabala, kanye nama-inhalers) azimeleki ezinganeni futhi izingane ezincane zingazivula kalula. Ukuvikela izingane ezisencane ekufakeni ubuthi, hlala uvala amakepisi okuphepha bese ubeka umuthi endaweni ephephile - eyodwa ephezulu futhi engekho futhi engabonakali kubo futhi efinyelela kuyo. http://www.upandaway.org

Imithi engadingeki kufanele ilahlwe ngezindlela ezikhethekile zokuqinisekisa ukuthi izilwane ezifuywayo, izingane nabanye abantu abakwazi ukuzidla. Kodwa-ke, akufanele ukhiphe le mithi ethoyilethi. Esikhundleni salokho, indlela engcono kakhulu yokulahla imithi yakho ngohlelo lokubuyisa umuthi. Khuluma nosokhemisi wakho noma uthinte umnyango wangakini wokulahla udoti / wokusebenzisa kabusha ukuze ufunde ngezinhlelo zokubuyisa emphakathini wakho. Bheka iwebhusayithi yakwa-FDA's Safe Disposal of Medicines (http://goo.gl/c4Rm4p) ukuthola eminye imininingwane uma ungakwazi ukufinyelela kuhlelo lokubuyisa.

Uma kwenzeka ukweqisa ngokweqile, shayela ucingo losizo lokulawula ubuthi ku-1-800-222-1222. Imininingwane iyatholakala online ku-https: //www.poisonhelp.org/help. Uma isisulu siwile, saba nokuquleka, sinenkinga yokuphefumula, noma singakwazi ukuvuswa, shayela ngokushesha abezimo eziphuthumayo ku-911.

Izimpawu zokudlula ngokweqile zingafaka:

• ukushesha noma ukugijima kwenhliziyo

Gcina wonke ama-aphoyintimenti nodokotela wakho. Udokotela wakho uzoqapha umfutho wegazi lakho kaningi ngesikhathi sokwelashwa kwakho ngemikhiqizo yomjovo we-epoetin alfa.

Ngaphambi kokwenza noma yiluphi uvivinyo lwelabhoratri, tshela udokotela wakho kanye nabasebenzi belebhuthi ukuthi usebenzisa umkhiqizo womjovo we-epoetin alfa.

Ungavumeli omunye umuntu asebenzise imithi yakho. Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana nokugcwalisa umuthi wakho.

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-Epogen^®(I-Epoetin Alpha)
• I-Eprex^®(I-Epoetin Alpha)^¶
• Ukuzithoba^® (I-Epoetin Alpha)
• Bhala kabusha^®(I-Epoetin Alpha-epbx)

• EPO
• I-Erythropoietin Human Glycoform alpha (Recombinant)
• rHuEPO-alpha

^¶ Lo mkhiqizo onophawu alusekho emakethe. Ezinye izindlela ezijwayelekile zingatholakala.