I-Bosentan REMS Programme Software
Yini i-bosentan?
I-Bosentan umuthi kadokotela osetshenziswa ukwelapha izinhlobo ezithile ze-pulmonary arterial hypertension
(PAH), okuwumfutho wegazi ophakeme emithanjeni yamaphaphu.
I-Bosentan ingathuthukisa ikhono lakho lokuzivocavoca futhi inganciphisa ukuwohloka kwesimo sakho somzimba nezimpawu. I-Bosentan yehlisa umfutho wegazi ophakeme emaphashini akho futhi ivumela inhliziyo yakho iphampe kahle.
Yiziphi izingozi ezinkulu ze-bosentan?
I-Bosentan ingabangela izinkinga zesibindi futhi, uma ithathwa ngesikhathi sokukhulelwa, ingabangela ukukhubazeka okukhulu kokuzalwa. Zonke iziguli - ukusebenza kwesibindi kufanele kuqashelwe:
- Ngaphambi kokuthi uqale ukuthatha i-bosentan,
- Njalo ngenyanga ngenkathi uthatha i-bosentan, futhi
- Noma nini uma udokotela wakho e-oda ukuhlolwa
Iziguli zabesifazane - ukukhulelwa kufanele kugwenywe:
- Ngaphambi kokuthi uqale ukuthatha i-bosentan,
- Ngenkathi ethatha i-bosentan, futhi
- Inyanga eyodwa ngemva kokuqeda ukwelashwa kwe-bosentan
Iyini i-Bosentan Risk Evaluation and Mitigation Strategy (REMS)?
I-Bosentan Risk Evaluation and Mitigation Strategy (REMS) itshela iziguli nabahlinzeki bezempilo mayelana nezingozi zezinkinga zesibindi kanye nokukhubazeka okungathi sína kokuzalwa lapho bethatha i-bosentan. Le REMS idingwa yi-Food and Drug Administration (FDA). Zonke iziguli kufanele zibhalise ku-Bosentan REMS ukuze zithole i-bosentan.
I-Bosentan REMS Izidingo
- Welulekwa ngezidingo ze-Bosentan REMS kanye nobungozi bezinkinga zesibindi
- Bamba iqhaza ku-REMS ye-Bosentan inqobo nje uma uthatha imithi, nakwabesifazane abanamandla okuzala, inyanga eyodwa ngemva kokuqeda ukwelashwa kwe-bosentan.
- Thola ukuhlolwa kwesibindi ama-oda akho e-prescriber ngaphambi kokuqala ukwelashwa kanye nanyanga zonke ngemva kwalokho kuze kuphele ukwelashwa kwe-bosentan. Udokotela wakho uzoqapha isibindi sakho futhi angase alungise noma amise ukwelashwa kwakho uma kunezimpawu zezinkinga zesibindi
- Tshela udokotela wakho uma ube nezinkinga zesibindi, okuhlanganisa nezinkinga zesibindi ngenkathi usebenzisa eminye imithi
- Thinta i-Bosentan REMS noma ikhemisi ngaphambi kokuthola i-bosentan ukuze unikeze isiqinisekiso sokuthi ukuhlolwa kwesibindi kwamanje kuqediwe futhi welulekwa ngobungozi be-bosentan kanye nezimfuneko zakho ku-Bosentan REMS.
Abesifazane abangakhulelwa banezidingo ezengeziwe ku-REMS
Uthathwa njengowesifazane ongakhulelwa uma:
- Ungene ekuthombeni, noma ungakaqali ukuya esikhathini, futhi
- Yiba nesibeletho, futhi
Awuzange udlule ekunqamukeni kokuya esikhathini (awuzange ube nesikhathi sokuya esikhathini okungenani izinyanga eziyi-12 ngezizathu zemvelo, noma ukhishwe ama-ovari akho)
- Welulekwa ngezimfuneko ze-Bosentan REMS kanye nobungozi bokukhubazeka okungathi sína kokuzalwa
- Yelulekwa ngaphambi kwencwadi yakho kadokotela yokuqala kanye nenyanga ngayinye ngemva kwalokho ngesidingo sokusebenzisa ukulawulwa kokuzalwa okuthembekile ngesikhathi sokwelashwa kwe-bosentan, kanye nenyanga eyodwa ngemva kokuqeda ukwelashwa kwe-bosentan.
- Qedela ukuhlolwa kokukhulelwa ngaphambi kokuqala ukwelashwa nge-bosentan, nyanga zonke ngesikhathi sokwelashwa kwe-bosentan, kanye nenyanga eyodwa ngemva kokuqeda ukwelashwa kwe-bosentan
- Xhumana ne-Bosentan REMS noma ikhemisi ngaphambi kokuthola i-bosentan ukuze unikeze isiqinisekiso sokuthi ukuhlolwa kokukhulelwa kwaqedwa ngaphambi kokuqala ukwelashwa, nyanga zonke ngesikhathi sokwelashwa, kanye nenyanga eyodwa ngemva kokuphela kokwelashwa kwe-bosentan.
- Yazisa udokotela wakho ngokushesha uma:
- Waya ocansini olungavikelekile
- Cabanga ukuthi ukulawula kwakho inzalo kuhlulekile
- Uphuthelwe ukuya esikhathini
- Cabanga ukuthi ukhulelwe
- Thinta ummeleli we-Bosentan REMS uma ukhulelwa ngenkathi use-bosentan noma phakathi nenyanga eyodwa ngemva kokuqeda ukwelashwa kwe-bosentan
- Owesifazane ongaphambi kokuthomba kufanele axhumane ngokushesha nodokotela wakhe lapho isiguli siqala ukuya esikhathini
Izinketho Zokulawula Ukuzalwa
Umhlinzeki wakho wokunakekelwa kwezempilo uzokhuluma nawe mayelana nezinketho zakho zokulawula inzalo ngaphambi kokuba uqale i-bosentan. Buza umhlinzeki wakho wezempilo uma unemibuzo. Tshela umhlinzeki wakho wezempilo uma ufuna ukushintsha isilawuli sakho sokuzalwa.
Kufanele ukhethe okukodwa kokukhethwa kukho okune okubalwe ngezansi. Kungase kudingeke izindlela ezingaphezu kweyodwa zokulawula inzalo njalo uma uya ocansini.
Izinketho zokulawula inzalo ezamukelekayo 
Izinyathelo zokwelashwa nge-bosentan
NGAPHAMBI KOKUQALA UKWELASHWA: Zonke Iziguli
- Qonda ubungozi bezinkinga zesibindi kanye nokukhubazeka kokuzalwa (kwabesifazane) ngenkathi uthatha i-bosentan
- Tshela udokotela wakho uma ube nezinkinga zesibindi, okuhlanganisa nezinkinga zesibindi ngenkathi uthatha eminye imithi
- Thola ukuhlolwa kwesibindi sakho
- Thola ukuhlolwa kwakho kokukhulelwa (kwabesifazane abangakhulelwa)
- Bhalisa ku-Bosentan REMS. Gcwalisa futhi usayine Ifomu Lokubhalisa Isiguli nodokotela wakho. I-prescriber yakho izogcwalisela iningi lefomu lokubhalisa. Kufanele ufunde futhi uvumelane nezidingo, bese usayina ukuze ubonise ukuthi uyaqonda futhi uzolandela imithetho yohlelo. Umzali/umnakekeli osemthethweni angakusayinela leli fomu
INYANGA NGANYE: Zonke Iziguli
- Funda Umhlahlandlela Wemithi oza nayo yonke incwadi kadokotela. Ulwazi olubalulekile kungenzeka lwengeziwe noma lushintshiwe
- Thola ukuhlolwa kwesibindi kwanyanga zonke oku-odwe ngudokotela wakho
- Gcwalisa incwadi yakho kadokotela ekhemisi eliqinisekisiwe. Ikhemisi eliqinisekisiwe yikhemisi eligunyazwe i-Bosentan REMS ukuthi likunikeze i-bosentan. Ukuze uthole uhlu lwamakhemisi aqinisekisiwe, sicela ushayele i-Bosentan REMS kokuthi 1-866-359-2612 noma vakashela ku-www.BosentanREMSProgram.com
- I-Bosentan REMS noma ikhemisi izokushayela ucingo njalo ngenyanga ikubuze ukuthi uke wahlolwa yini isibindi futhi welulekwa ngengozi yezinkinga zesibindi ngaphambi kokuba uthole i-bosentan yakho. Uma umhlinzeki wakho wokunakekelwa kwezempilo eseyazisile kakade i-Bosentan REMS ukuthi usuqedile ukuhlola nokwelulekwa, ngeke uthole ucingo oluvela kwa-Bosentan REMS ngaleyo nyanga. Ukugcwaliswa kabusha kungase kungalungeli ngesikhathi uma ungazange uhlolwe isibindi sakho nokwelulekwa
- Tshela udokotela wakho ngokushesha uma unesinye salezi zimpawu zezinkinga zesibindi ngenkathi uthatha i-bosentan: isicanucanu, ukuhlanza, umkhuhlane, ukukhathala okungajwayelekile, ubuhlungu bendawo yesisu (besisu), noma ukuphuzi kwesikhumba noma amehlo amhlophe (i-jaundice)
INYANGA NENYANGA: Iziguli Zabesifazane Ezingakhulelwa
- Sebenzisa indlela/izindlela zokulawula inzalo okuvunyelwene ngazo nomhlinzeki wakho wokunakekelwa kwezempilo phakathi nokwelashwa
- Thola ukuhlolwa kokukhulelwa kwanyanga zonke oku-odwe ngudokotela wakho
- I-Bosentan REMS noma ikhemisi izokushayela ucingo njalo ngenyanga ikubuze ukuthi uke wahlolelwa yini ukukhulelwa futhi welulekwa ngengozi yokukhubazeka kokuzalwa ngaphambi kokuba uthole i-bosentan yakho. Uma umhlinzeki wakho wokunakekelwa kwezempilo eseyazisile kakade i-Bosentan REMS ukuthi usuqedile ukuhlola nokwelulekwa, ngeke uthole ucingo oluvela kwa-Bosentan REMS ngaleyo nyanga. Ukugcwaliswa kabusha kungase kungalungeli ngesikhathi uma ungazange uhlolwe ukukhulelwa kanye nokwelulekwa
- Ungakhulelwa. Tshela udokotela wakho ngokushesha uma: Uye ocansini olungavikelekile, ucabanga ukuthi uhlelo lwakho lokuzalwa lwehlulekile, weqiwa ukuya esikhathini, ucabanga ukuthi ukhulelwe.
INYANGA EYODWA NGEMVA KOKUPHELA UKWELASHWA KWE-BOSENTAN: Iziguli Zabesifazane Ezingakhulelwa
- Sebenzisa indlela(izindlela) ezithembekile zokulawula inzalo okuvunyelwene ngazo nomhlinzeki wakho wokunakekelwa kwezempilo inyanga eyodwa ngemva kokuqeda ukwelashwa kwe-bosentan
Thola ukuhlolwa kokukhulelwa kokugcina okuyalwe ngudokotela wakho - Ungakhulelwa. Tshela udokotela wakho ngokushesha uma: Uye ocansini olungavikelekile, ucabanga ukuthi uhlelo lwakho lokuzalwa lwehlulekile, weqiwa ukuya esikhathini, ucabanga ukuthi ukhulelwe.
Ungafinyelela i-Bosentan REMS ngokushayela ucingo mahhala ku-1-866-359-2612.
Ukuze uthole ulwazi olwengeziwe mayelana ne-Bosentan REMS, sicela uvakashele www.BosentanREMSProgram.com.
Amadokhumenti / Izinsiza
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I-Bosentan REMS Programme Software [pdf] Umhlahlandlela Womsebenzisi Uhlelo lwe-REMS, Isofthiwe, Isofthiwe Yohlelo lwe-REMS |
