Inaliti yeVedolizumab

-Delile

• Umjovo we-Vedolizumab usetshenziselwa ukuqeda izimpawu zezifo ezithile ezizimele (izimo lapho amasosha omzimba ehlasela khona izingxenye ezinempilo zomzimba futhi abangele ubuhlungu, ukuvuvukala, nokulimala) kwepheshana lesisu kubandakanya:
• Ngaphambi kokuthatha i-vedolizumab,
• IVedolizumab ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

Umjovo we-Vedolizumab usetshenziselwa ukuqeda izimpawu zezifo ezithile ezizimele (izimo lapho amasosha omzimba ehlasela khona izingxenye ezinempilo zomzimba futhi abangele ubuhlungu, ukuvuvukala, nokulimala) kwepheshana lesisu kubandakanya:

• Isifo sikaCrohn (isimo lapho umzimba uhlasela ulwelwesi lomgudu wokugaya ukudla, ubangele ubuhlungu, isifo sohudo, ukuncipha komzimba nomkhuhlane) okungazange kuthuthuke lapho welashwa ngeminye imithi.
• i-ulcerative colitis (isimo esidala ukuvuvukala nezilonda kulwelwesi lwamathumbu amakhulu) esingathuthukile lapho selashwa ngeminye imithi.

Umjovo we-Vedolizumab usekilasini lemithi ebizwa nge-integrin receptor antagonists. Isebenza ngokuvimba ukusebenza kwamaseli athile emzimbeni adala ukuvuvukala.

Umjovo we-Vedolizumab uza njengempuphu ezohlanganiswa namanzi oyinyumba bese ufakwa ngomjovo (emthanjeni) ngaphezu kwemizuzu engama-30 ngudokotela noma unesi. Imvamisa inikezwa ehhovisi likadokotela kanye njalo emavikini amabili kuya kwayisishiyagalombili, kaningi ekuqaleni kokwelashwa kwakho futhi kaningi njengoba ukwelashwa kwakho kuqhubeka.

Umjovo we-Vedolizumab ungadala ukusabela okweqile komzimba ngesikhathi sokumnika kanye namahora ambalwa ngemuva kwalokho. Udokotela noma umhlengikazi uzokuqapha ngalesi sikhathi ukuze aqiniseke ukuthi awunampendulo ebucayi emithini. Unganikezwa eminye imithi yokwelapha ukusabela kumjovo we-vedolizumab. Tshela udokotela wakho noma umhlengikazi ngokushesha uma uhlangabezana nalezi zimpawu ezilandelayo ngesikhathi sokumnika noma ngemuva kokumnika: ukuqubuka; ukulunywa; ukuvuvukala kobuso, amehlo, umlomo, umphimbo, ulimi, noma izindebe; ubunzima bokuphefumula noma ukugwinya; ukuphefumula, ukuqhuma; isiyezi; ukuzwa ushisa; noma ukushaya kwenhliziyo okusheshayo noma okugijimayo.

Umjovo we-Vedolizumab ungasiza ukulawula izimpawu zakho, kepha ngeke uselaphe isimo sakho. Udokotela wakho uzokubuka ngokucophelela ukuze abone ukuthi umjovo we-vedolizumab usebenza kanjani kuwe. Uma isimo sakho singakathuthuki ngemuva kwamasonto ayi-14, udokotela wakho angayeka ukukuphatha ngomjovo we-vedolizumab. Kubalulekile ukutshela udokotela wakho ukuthi uzizwa kanjani ngesikhathi sokwelashwa kwakho.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa ngomjovo we-vedolizumab futhi isikhathi ngasinye uthola umuthi. 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.

Lo muthi ungabekelwa okunye ukusetshenziswa; buza udokotela wakho noma usokhemisi ukuthola eminye imininingwane.

Ngaphambi kokuthatha i-vedolizumab,

• Tshela udokotela wakho kanye nosokhemisi uma unegciwane ku-vedolizumab, noma imuphi omunye umuthi, noma yiziphi izithako zomjovo we-vedolizumab. 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. Qiniseka ukuthi usho noma yikuphi okulandelayo: adalimumab (Humira), certolizumab (Cimzia), golimumab (Simponi), infliximab (Remicade), noma natalizumab (Tysabri). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• Tshela udokotela wakho uma unezinkinga zesibindi, uma unesifo sofuba noma ubusondelene kakhulu nomuntu onesifo sofuba, noma uma njengamanje unesifo noma ucabanga ukuthi unesifo, noma uma unezifo ezizayo nezenzekayo noma izifo eziqhubekayo ezenzekayo ungahambi.
• utshele udokotela wakho uma ukhulelwe, hlela ukukhulelwa, noma uncelisa. Uma ukhulelwa ngenkathi uthatha i-vedolizumab, shayela udokotela wakho.
• buza udokotela wakho ukuthi kufanele yini ugonywe ngaphambi kokuba uqale ukwelashwa ngomjovo we-vedolizumab. Uma kunokwenzeka, yonke imigomo kufanele ihanjiswe kuze kube yimanje ngaphambi kokuqala ukwelashwa. Ungabi nayo imigomo ngesikhathi sokwelashwa kwakho ngaphandle kokukhuluma nodokotela wakho.

Ngaphandle kokuthi udokotela wakho akutshele ngenye indlela, qhubeka nokudla okuvamile.

Uma uphuthelwa i-aphoyintimenti yokuthola ukumnika kwe-vedolizumab, shayela udokotela wakho ngokushesha okukhulu.

IVedolizumab ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• ikhanda
• isicanucanu
• ubuhlungu obuhlangene noma obuya emuva
• ubuhlungu ezingalweni nasemilenzeni

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• umkhuhlane, ukukhwehlela, ikhala eligobayo, umphimbo obuhlungu, amakhaza, ubuhlungu nezinye izimpawu zokutheleleka
• isikhumba esibomvu noma esibuhlungu noma izilonda emzimbeni wakho
• ubuhlungu ngesikhathi uchama
• ukudideka noma izinkinga zememori
• ukulahlekelwa ibhalansi
• izinguquko ekuhambeni noma enkulumweni
• ukuncipha kwamandla noma ubuthakathaka ngakolunye uhlangothi lomzimba wakho
• ukungaboni kahle noma ukulahleka kombono
• ukukhathala ngokweqile
• ukulahlekelwa isifiso sokudla
• ubuhlungu engxenyeni engenhla kwesokudla yesisu
• ukulimaza noma ukopha okungavamile
• umchamo omnyama
• ukuphuzi kwesikhumba noma kwamehlo

IVedolizumab ingadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthatha 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).

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.

Gcina wonke ama-aphoyintimenti nodokotela wakho.

Buza usokhemisi wakho noma imiphi imibuzo onayo mayelana ne-vedolizumab.

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-Entyvio^®