Umjovo weBrexanolone

-Delile

• Ngaphambi kokuthola i-brexanolone,
• I-Brexanolone ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:
• Eminye imiphumela emibi ingaba mibi. Uma uhlangabezana nenye yalezi zimpawu noma lezo ezibalwe esigabeni ESIBALULEKILE SEXWAYISO, shayela udokotela wakho ngokushesha noma uthole ukwelashwa okuphuthumayo:
• Izimpawu zokudlula ngokweqile zingafaka:

Umjovo weBrexanolone ungakubangela ukuthi uzizwe ulele kakhulu noma ulahlekelwe ngokuzumayo ngesikhathi sokwelashwa. Uzothola umjovo we-brexanolone esikhungweni sezokwelapha. Udokotela wakho uzokuhlolela izimpawu zokulala njalo emahoreni amabili ngenkathi uphapheme. Tshela udokotela wakho ngaso leso sikhathi uma ukhathele ngokweqile, uma uzizwa sengathi awukwazi ukuhlala uphapheme ngesikhathi ovame ngaso ukuphaphama, noma uma uzizwa sengathi uzoquleka.

Kufanele ube nomnakekeli noma ilungu lomndeni elikusizayo ngengane yakho (ren) ngesikhathi nangemva kokuthola umjovo we-brexanolone.

Ungashayeli imoto noma usebenzise imishini uze ungabe usazizwa ukozela noma ukozela ngemuva kokufakwa kwakho kwe-brexanolone.

Ngenxa yezingozi zalo muthi, i-brexanolone itholakala kuphela ngohlelo olukhethekile lokusabalalisa olukhawulelwe. Uhlelo olubizwa ngohlelo lweZulresso Risk Evaluation and Mitigation Strategies (REMS). Wena, udokotela wakho, kanye nekhemisi lakho kumele nibhalise ohlelweni lweZulresso REMS ngaphambi kokuthi niluthole. Uzothola i-brexanolone esikhungweni sezokwelapha ngaphansi kokubhekwa udokotela noma omunye uchwepheshe wezokunakekelwa kwezempilo.

Gcina wonke ama-aphoyintimenti nodokotela wakho.

Udokotela wakho noma usokhemisi uzokunikeza ishidi lemininingwane yesiguli lomkhiqizi (Umhlahlandlela Wezokwelapha) lapho uqala ukwelashwa nge-brexanolone 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) noma iwebhusayithi yomkhiqizi ukuthola i-Medication Guide.

Umjovo weBrexanolone usetshenziselwa ukwelashwa kokucindezeleka kwangemva kokubeletha (PPD) kubantu abadala. Umjovo weBrexanolone usesigabeni semithi ebizwa nge-neurosteroid antidepressants. Isebenza ngokushintsha ukusebenza kwezinto ezithile zemvelo ebuchosheni.

IBrexanolone iza njengesisombululo sokujova ngomjovo (emthanjeni wakho). Imvamisa inikezwa njengokufakwa okwesikhathi esisodwa ngaphezulu kwamahora angama-60 (izinsuku ezi-2.5) esikhungweni sezokwelapha.

Udokotela wakho angamisa ukwelashwa kwakho okwesikhashana noma unomphela noma alungise umthamo wakho we-brexanolone ngokuya ngempendulo yakho ekwelashweni nanoma yimiphi imiphumela emibi oyitholayo.

I-Brexanolone ingaba yindlela yokwakha umkhuba. Ngenkathi uthola i-brexanolone, xoxa ngezinhloso zakho zokwelashwa nomhlinzeki wakho wezokunakekelwa kwempilo.

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

Ngaphambi kokuthola i-brexanolone,

• Tshela udokotela kanye nosokhemisi wakho uma kukhona okweqile kunoma yimiphi imithi, noma yiziphi izithako zomjovo we-brexanolone. 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 ikuphi kokulandelayo: imishanguzo, i-benzodiazepines kufaka phakathi i-alprazolam (Xanax), i-diazepam (i-Diastat, i-Valium), i-midazolam, noma i-triazolam (i-Halcion); imishanguzo yokugula ngengqondo, imishanguzo yezinhlungu ezifana nama-opioid, imishanguzo yokuquleka, izidambisi, amaphilisi okulala, kanye nezidambisi. Udokotela wakho angadinga ukushintsha imithamo yemithi yakho noma akuqaphele ngokucophelela ngemiphumela emibi.
• Tshela udokotela wakho uma uke waba nesifo sezinso noma wake waba naso.
• tshela udokotela wakho uma ukhulelwe noma uma ucabanga ukuthi kungenzeka ukhulelwe, noma uncelisa ibele.
• kufanele wazi ukuthi utshwala bungenza imiphumela emibi ye-brexanolone ibe yimbi kakhulu. Ungaphuzi utshwala ngenkathi uthola i-brexanolone.
• kufanele wazi ukuthi impilo yakho yengqondo ingashintsha ngezindlela ezingalindelekile lapho uthola i-brexanolone noma amanye ama-anti-depressants noma ngabe ungumuntu omdala ongaphezu kweminyaka engama-24. Ungazibulala, ikakhulukazi ekuqaleni kokwelashwa kwakho futhi noma nini lapho kushintshwa umthamo wakho. Wena, umndeni wakho, noma umnakekeli wakho kufanele ushayele udokotela wakho ngokushesha uma uhlangabezana nalezi zimpawu ezilandelayo: ukucindezeleka okusha noma okuya kuba kubi; ukucabanga ngokuzilimaza noma ukuzibulala, noma ukuhlela noma ukuzama ukwenza kanjalo; ukukhathazeka ngokweqile; ukuyaluza; ukwethuka; ubunzima bokulala noma ukulala; isimilo esinolaka; ukucasuka; ukwenza ngaphandle kokucabanga; ukungahlaliseki okukhulu; nokuhlanya okungajwayelekile. Qiniseka ukuthi umndeni wakho noma umnakekeli wakho uyazi ukuthi yiziphi izimpawu ezingaba zimbi kakhulu ukuze bakwazi ukubiza udokotela uma ungakwazi ukuzifunela ukwelashwa wedwa.

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

I-Brexanolone ingadala imiphumela emibi. Tshela udokotela wakho uma kukhona kulezi zimpawu ezinzima noma ezingapheli:

• umlomo owomile
• isilungulela
• ubuhlungu bomlomo noma bomphimbo
• ukuqhuma
• ukushisa okushisayo
• isiyezi noma ukuzwa ukuphotha
• ukukhathala

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

• ukushaya kwenhliziyo okugijimayo

I-Brexanolone ingadala eminye imiphumela emibi. Shayela udokotela wakho uma unezinkinga ezingavamile ngenkathi uthola 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.

Izimpawu zokudlula ngokweqile zingafaka:

• ukuthambisa
• ukulahlekelwa ukwazi

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

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-Zulresso^®