Macitentan

-Delile

• Ngaphambi kokuthatha i-macitentan,
• IMacitentan ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu, yeka ukuthatha i-macitentan bese ushayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:
• Izimpawu zokudlula ngokweqile zingafaka:

Ezigulini zesifazane:

Ungathathi i-macitentan uma ukhulelwe noma uhlela ukukhulelwa. Kukhona ingozi enkulu yokuthi i-macitentan izolimaza umbungu.

Ngenxa yobungozi bokulimala kombungu, uhlelo olubizwa nge-OPSUMIT Risk Evaluation and Mitigation Strategy (i-OPSUMIT REMS) lusethelwe ukwenza isiqiniseko sokuthi owesifazane okhulelwe akayithathi i-macitentan, nokuthi lowo wesifazane akakhulelwa ngenkathi ethatha i-macitentan. Bonke abesifazane, kufaka phakathi abesifazane abangakwazi ukukhulelwa, bangathola kuphela i-macitentan uma bebhaliswe ne-OPSUMIT REMS, banesidakamizwa esivela kudokotela obhaliswe ne-OPSUMIT REMS, bese begcwalisa incwadi ekhemisi ebhaliswe ne-OPSUMIT REMS.

Udokotela wakho uzokubhalisa ku-OPSUMIT REMS. Udokotela wakho uzokutshela ngobungozi be-macitentan, ikakhulukazi ubungozi bokukhubazeka okukhulu kokuzalwa uma uthathwe ngenkathi ukhulelwe. Kufanele usayine iphepha lokuvuma elinolwazi elisho ukuthi uyaluqonda lolu lwazi ukuze udokotela wakho akubhalise.

Udokotela wakho uzonquma nokuthi uyakwazi yini ukukhulelwa. Uma usufinyelele ebusheni (lapho umzimba wengane usuvuthwa ngokomzimba futhi ukwazi ukuba nengane), ube nesibeletho, futhi ungakafiki esikhathini sokuya esikhathini ('ushintsho empilweni' ekupheleni kwezinyanga zokuya esikhathini) uthathwa njengowesifazane okwaziyo ukukhulelwa, futhi kuzofanele ulandele imithetho ethile eyengeziwe ukuze uthole i-macitentan.

Kwabesifazane abakwaziyo ukukhulelwa:

Kufanele usebenzise ukulawulwa kokuzalwa okuthembekile kulo lonke ukwelashwa kwakho nge-macitentan, nangenyanga e-1 ngemuva komthamo wakho wokugcina. Udokotela wakho uzokutshela ukuthi iziphi izindlela zokulawula ukubeletha ezamukelekayo, futhi uzokunikeza imininingwane yakho ebhaliwe mayelana nokulawulwa kokuzalwa. Ezimweni eziningi kuzodingeka ukuthi usebenzise izindlela ezimbili zokulawula inzalo ukuvikela ukukhulelwa ngenkathi uthatha i-macitentan.

Kuzofanele uthathe ukuhlolwa kokukhulelwa ngaphambi kokuqala ukwelashwa, njalo ngenyanga ngenkathi welashwa, nangenyanga engu-1 ngemuva komthamo wakho wokugcina ukuze ukwazi ukuthola i-macitentan. Udokotela wakho uzoku-oda izivivinyo zokukhulelwa. Ikhemisi ngeke likunikeze i-macitentan ize ikuqinisekise ukuthi uthathe izivivinyo zakho zokukhulelwa ezidingekayo.

Akufanele uye ocansini olungaphephile ngenkathi uthatha i-macitentan.

Shayela udokotela wakho ngokushesha uma uye ocansini olungaphephile, cabanga ukuthi ukulawula kwakho ukubeletha kwehlulekile, wehluleka ukuya esikhathini, noma ucabanga ukuthi kungenzeka ukhulelwe nganoma yisiphi isizathu. Uzoxoxa nawe ngezinketho zakho zokwelashwa. Musa ukulinda kuze kube ukuqokwa kwakho okulandelayo ukuxoxa ngalokhu nodokotela wakho.

Tshela udokotela wakho uma ungakuqondi konke otshelwe kona ngokulawulwa kokubeletha, noma uma ungacabangi ukuthi uzokwazi ukusebenzisa izindlela ezamukelekayo zokulawula ukubeletha ngaso sonke isikhathi ngesikhathi sokwelashwa kwakho.

Uma ungumzali noma umnakekeli wowesifazane owayengakafiki ebusheni, hlola ingane yakho njalo ukuze ubone ukuthi ingabe ikhona yini izimpawu zokuthomba (amabele efihlekile, izinwele zasesidlangalaleni) futhi yazise udokotela wayo nganoma yiziphi izinguquko.

Kuzo zonke iziguli:

IMacitentan ayitholakali ezikhemisi ezithengisa. Imithi yakho izothunyelwa kuwe ngeposi ekhemisi ekhethekile ebhaliswe ne-OPSUMIT REMS. Uma ungowesifazane ongakafiki ebusheni noma owesifazane okwaziyo ukukhulelwa uzothola kuphela ukuthengwa kwezinsuku ezingama-30 ngasikhathi. Buza udokotela wakho uma unemibuzo mayelana nokuthi uzowuthola kanjani umuthi wakho.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa nge-macitentan 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.

IMacitentan isetshenziselwa ukuphatha izimpawu zomfutho wegazi ophakeme wamaphaphu (PAH; umfutho wegazi ophakeme ezitsheni ezihambisa igazi emaphashini). IMacitentan isekilasini lemithi ebizwa nge-endothelin receptor antagonists. Isebenza ngokumisa isenzo se-endothelin, into yemvelo ebangela ukuthi imithambo yegazi inciphise futhi ivimbele ukugeleza kwegazi okujwayelekile kubantu abane-PAH.

IMacitentan iza njengethebhulethi ezothathwa ngomlomo. Imvamisa kuthathwa nokudla noma ngaphandle kokudla kanye ngosuku. Thatha i-macitentan ngasikhathi sinye nsuku zonke. Landela izinkomba ezikulebuli kadokotela wakho ngokucophelela, bese ubuza udokotela noma usokhemisi wakho ukuthi akuchaze nganoma iyiphi ingxenye ongayiqondi. Thatha i-macitentan njengoba nje kuqondisiwe. Ungayithathi kancane noma uyithathe kaningi kunokuyalelwa ngudokotela wakho.

Gwinya wonke amaphilisi; ungawahlukanisi, ungawahlafune noma uwagxoze.

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

Ngaphambi kokuthatha i-macitentan,

• Tshela udokotela kanye nosokhemisi wakho uma unegciwane ku-macitentan, noma imuphi omunye umuthi, noma iziphi izithako ezikumaphilisi e-macitentan. Buza usokhemisi wakho noma uhlole Umhlahlandlela Wezokwelapha ukuthola uhlu lwezithako.
• Tshela udokotela wakho kanye nosokhemisi ukuthi imiphi imishanguzo kadokotela noma engabhaliswanga, amavithamini, kanye nezithako zokudla okunomsoco ozithathayo noma ohlela ukuzithatha. Qiniseka ukuthi usho noma yikuphi okulandelayo: carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), clarithromycin (Biaxin, ku-Prevpac); i-efavirenz (Sustiva); ezinye ze-HIV protease inhibitors ezifana ne-nelfinavir (i-Viracept), i-indinavir (i-Crixivan), ne-ritonavir (i-Norvir, e-Kaletra); itraconazole (Onmel, Sporanox); ketoconazole; nefazodone; i-nevirapine Viramune); i-phenobarbital; i-phenytoin (iDilantin, Phenytek); i-rifabutin (i-Mycobutin); kanye ne-rifampin (Rifadin, Rifamate, Rifater, Rimactane). Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi. Eminye imishanguzo eminingi ingaxhumana ne-macitentan, ngakho-ke qiniseka ukuthi utshela udokotela wakho ngayo yonke imithi oyiphuzayo, ngisho naleyo engabonakali kulolu hlu.
• utshele udokotela wakho ukuthi uthatha miphi imikhiqizo yamakhambi, ikakhulukazi iSt John's wort.
• Tshela udokotela wakho uma uke waba ne-anemia (isimo lapho amangqamuzana abomvu egazi engalethi umoya-mpilo owanele ezithweni) noma isifo sesibindi.
• ungancelisi ibele ngenkathi uthatha lo muthi.
• kufanele wazi ukuthi lo muthi unganciphisa ukuzala emadodeni. Khuluma nodokotela wakho ngezingozi zokuthatha i-macitentan.

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

Thatha umthamo ongabanjwanga ngokushesha nje lapho uwukhumbula. Kodwa-ke, uma sekuyisikhathi somthamo olandelayo, weqa umthamo ongabanjwanga bese uqhubeka neshejuli yakho ejwayelekile yokulinganisa. Ungathathi umthamo ophindwe kabili ukwenza okulahlekile.

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

• ikhala eligcwele
• Umphimbo obuhlungu
• ukukhwehlela
• umkhuhlane njengezimpawu
• ikhanda
• ukuchama okuphuthumayo, okuvamile, noma okubuhlungu
• ukuqubuka

Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu, yeka ukuthatha i-macitentan bese ushayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:

• isikhumba esilumayo
• umchamo omnyama
• ukuphuzi kwesikhumba sakho noma kwamehlo akho
• ubuhlungu engxenyeni engenhla yangakwesokudla yesisu sakho
• isicanucanu noma ukuhlanza okungachazeki
• ukulahlekelwa isifiso sokudla
• ukukhathala ngokweqile
• imfiva
• ukuvuvukala kobuso, umphimbo, ulimi, izindebe namehlo
• ubunzima bokugwinya noma ukuphefumula
• ukushaqeka
• ukuphefumula, ikakhulukazi lapho ulele phansi
• ukukhwehlela upinki, isikhwehlela esibandayo noma igazi
• ukwanda kwesisindo okungavamile
• ukuvuvukala kwamaqakala noma imilenze

IMacitentan 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).

Gcina le mithi esitsheni efike ngayo, ivalwe ngokuqinile, futhi lapho izingane zingafinyeleleki khona. Gcina ekamelweni lokushisa futhi kude nokushisa okweqile nomswakama (hhayi endlini yangasese).

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:

• ikhanda
• isicanucanu
• ukuhlanza

Gcina wonke ama-aphoyintimenti nodokotela wakho kanye nelabhorethri. Udokotela wakho anga-oda ukuhlolwa ukuze abone ukuthi isibindi sakho sisebenza kahle kangakanani, nokuthi ahlole i-anemia ngaphambi kokuqala ukwelashwa futhi ngezikhathi ezithile ngenkathi welashwa nge-macitentan.

Ungavumeli omunye umuntu ukuthi athathe 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-Opsumit^®