I-Tolvaptan (isifo sezintso)

Umxholo

• Ngaphambi kokuba uthathe i-tolvaptan (Jynarque),
• I-Tolvaptan (Jynarque) inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:
• Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko:
• Iimpawu zokudlula ngaphezulu zinokubandakanya:

I-Tolvaptan (Jynarque) inokubangela ukonakala kwesibindi, ngamanye amaxesha kube nzima kakhulu ukufuna ukufakelwa kwesibindi okanye ukubangela ukufa. Tshela ugqirha wakho ukuba ukhe waba neengxaki zesibindi, kubandakanya i-hepatitis. Ugqirha wakho unokukuxelela ukuba ungathathi i-tolvaptan (Jynarque). Ugqirha wakho uya ku-odola iimvavanyo zaselebhu rhoqo ngaphambi kwaye ngexesha lonyango lwakho ukuze ubone ukuba i-tolvaptan (Jynarque) iyasichaphazela na isibindi sakho. Ugqirha wakho angakuxelela ukuba akufuneki ufumane eli yeza xa uvavanyo lubonisa ukuba unengxaki yesibindi. Ukuba unazo naziphi na kwezi mpawu zilandelayo, tsalela umnxeba kwangoko: isicaphucaphu, ukugabha, ukudinwa kakhulu, ukopha okungaqhelekanga okanye ukugruzuka, ukunqongophala kwamandla, ukuphelelwa ngumdla wokutya, iintlungu kwinxalenye ephezulu yesisu, ukuba tyheli kolusu okanye amehlo , umchamo wombala omnyama, irhashalala, ukurhawuzelela, okanye iimpawu ezifana nomkhuhlane.

Ngenxa yomngcipheko ngeli chiza, i-tolvaptan (Jynarque) ifumaneka kuphela kwinkqubo ekhethekileyo yokuhambisa. Inkqubo ebizwa ngokuba yiJynarque Risk Evaluation and Mitigation Strategies (REMS) isetelwe ukunciphisa umngcipheko wokuthatha i-tolvaptan (Jynarque). Ugqirha wakho kunye nosokhemesti kufuneka babhaliswe kwinkqubo ye-Jynarque REMS. Buza ugqirha wakho ngolwazi oluthe kratya malunga nale nkqubo kunye nendlela oza kuwafumana ngayo amayeza akho. Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho uya kuyalela iimvavanyo ezithile ngaphambi nangexesha lonyango lwakho ukujonga impendulo yomzimba wakho kwi-tolvaptan (Jynarque).

Ugqirha wakho okanye usokhemesti uya kukunika uxwebhu lolwazi lwesigulana lomenzi (Isikhokelo seyeza) xa uqala unyango nge-tolvaptan (Jynarque) kwaye ngalo lonke ixesha uzalisa amayeza akho. Funda ulwazi ngononophelo kwaye ubuze ugqirha okanye usokhemesti ukuba unayo nayiphi na imibuzo. Ungandwendwela noLawulo lwezoKutya noLawulo lweziyobisi (FDA) iwebhusayithi (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) okanye iwebhusayithi yomenzi ukufumana isiKhokelo seMithi.

Thetha nogqirha wakho malunga nomngcipheko wokuthatha i-tolvaptan (Jynarque).

I-Tolvaptan (Jynarque) isetyenziselwa ukunciphisa ukusebenza kakubi kwezintso kwizigulana ezithile ezine-autosomal isifo sesifo sezintso (ADPKD; uhlobo oluthile lwesifo sezintso esizuzwe njengelifa). I-Tolvaptan (Jynarque) ikwiklasi yamayeza abizwa ngokuba yi-vasopressin V₂ abachasi be-receptor. Isebenza ngokwandisa inani lamanzi akhululwe emzimbeni njengomchamo kwaye kunciphisa ukukhula kwama-cysts kwizintso. Ukususa ulwelo emzimbeni kunye nokunciphisa ukukhula kwee-cysts kunceda ukucothisa ukwanda kokusebenza kwezintso.

I-Tolvaptan ikwafumaneka njengecwecwe (iSamsca) ukunyanga amanqanaba egazi asezantsi esodium kubantu abanesifo sentliziyo okanye ezinye iimeko ezithile. Le monograph inika kuphela ulwazi malunga neepilisi ze-tolvaptan (Jynarque) zokucothisa ukwanda kokusebenza kwezintso kwizigulana ezine-ADPKD. Ukuba usebenzisa eli yeza ukunyanga amanqanaba asezantsi esodiyam egazini, funda i-monograph enesihloko esithi tolvaptan (isodiyam yegazi ephantsi).

I-Tolvaptan (Jynarque) iza njengecwecwe lokuthatha ngomlomo. Ihlala ithathwa kabini ngemini, ithebhulethi enye kusasa kunye nethebhulethi enye kwiiyure eziyi-8 kamva, kunye okanye ngaphandle kokutya. Landela izikhokelo kwileyibhile yakho yonyango ngononophelo, kwaye ubuze ugqirha wakho okanye usokhemesti ukuba achaze nayiphi na indawo ongayiqondiyo. Thatha i-tolvaptan (Jynarque) ngokuchanekileyo njengoko kuyalelwe. Musa ukuthatha ngaphezulu okanye ngaphantsi kwayo okanye uthathe rhoqo kunokuba umiselwe ngugqirha wakho.

Ugqirha wakho uya kukuqala ngedosi esezantsi ye-tolvaptan (Jynarque) kwaye ngokuthe ngcembe wandise idosi yakho.

Ugqirha wakho unokufuna ukunciphisa idosi yakho ukuba uneziphumo ebezingalindelekanga ezithile. Kubalulekile ukuba uxelele ugqirha wakho ukuba uziva njani ngexesha lonyango lwakho.

Eli yeza linokumiselwa ezinye izinto; buza ugqirha wakho okanye usokhemesti ngolwazi oluthe kratya.

Ngaphambi kokuba uthathe i-tolvaptan (Jynarque),

• xelela ugqirha wakho kunye nosokhemesti ukuba ngaba uxabana ne-tolvaptan (Jynarque, Samsca), nawaphi na amanye amayeza, okanye nasiphi na isithako kwiipilisi ze-tolvaptan. Buza usokhemesti wakho okanye ujonge isiKhokelo seyeza ukuze ufumane uluhlu lwezithako.
• xelela ugqirha wakho ukuba uthatha ii-antifungal ezithile ezinje nge ketoconazole (Nizoral) okanye itraconazole (Sporanox); i-clarithromycin (i-Biaxin); okanye amayeza athile e-HIV afana ne-indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), okanye saquinavir (Invirase); ikhonkco (Vaprisol); okanye nefazodone. Ugqirha wakho unokukuxelela ukuba ungathathi i-tolvaptan (Jynarque) ukuba uthatha elinye okanye ngaphezulu kula mayeza.
• xelela ugqirha wakho kunye nosokhemesti ukuba loluphi olunye amayeza amiselweyo kunye nalawo angabhalwanga, iivithamini, izongezo zesondlo, kunye nemveliso yamayeza owathathayo okanye oceba ukuyithatha. Qiniseka ukuba ukhankanya nayiphi na kwezi zinto zilandelayo: atorvastatin (Lipitor, eCaduet), bosentan (Tracleer), desmopressin (dDAVP, Minirin, Noctiva), digoxin (Lanoxin), fluconazole (Diflucan); furosemide (Lasix), glyburide (Diabeta, Glynase), lovastatin (Altoprev), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), nateglinide (Starlix), pravastatin (Pravachol), repaglinide (Prandin), rifampin (Rifadin ), I-rosuvastatin (iCrestor), kunye ne-simvastatin (iZocor, eVytorin). Ugqirha wakho unokufuna ukutshintsha amayeza akho okanye akubeke esweni ngononophelo kwiziphumo ebezingalindelekanga. Amanye amayeza amaninzi anokusebenzisana ne-tolvaptan (Jynarque), ke qiniseka ukuxelela ugqirha wakho ngawo onke amayeza owathathayo, nkqu nalawo angaveli kolu luhlu.
• xelela ugqirha wakho ukuba unayo nayiphi na imiqathango ekhankanywe kwicandelo LESILUMKISO ELIBALULEKILEYO, ukuba ukhe wanayo inqanaba eliphezulu lesodiyam egazini lakho, ukuba unobunzima bokuchama okanye awunakho ukuchama, ukuba ngaba ugabhe kakhulu okanye urhudo okanye ucinga ukuba unokuphelelwa ngamanzi emzimbeni, okanye ukuba awukwazi ukuqaphela ukuba unxaniwe. Ugqirha wakho unokukuxelela ukuba ungathathi i-tolvaptan (Jynarque).
• xelela ugqirha wakho ukuba ukhulelwe, cwangcisa ukukhulelwa, okanye uncancisa. Ukuba ukhulelwa ngelixa uthatha i-tolvaptan (Jynarque), tsalela umnxeba ugqirha wakho. Akufanelanga ukuncancisa ngelixa uthatha i-tolvaptan (Jynarque).

Uya kudinga ukusela amanzi ngokwaneleyo ngelixa uthatha i-tolvaptan (Jynarque) ukuze unganxanwa okanye uphelelwe ngamanzi emzimbeni.

Musa ukuyitya i-grapefruit okanye usele ijusi yeziqhamo ngelixa uthatha eli yeza.

Tsiba idosi ephosiweyo kwaye uqhubeke neshedyuli yakho yesiqhelo yokulinganisa Sukuthatha idosi ephindwe kabini ukwenza eyilahlekileyo.

I-Tolvaptan (Jynarque) inokubangela iziphumo ebezingalindelekanga. Tshela ugqirha wakho ukuba ngaba ezinye zeempawu zinzima okanye azihambi:

• unxano
• umlomo owomileyo
• Ukuchama rhoqo
• isilungulela
• ukunciphisa ukutya

Ezinye iziphumo ebezingalindelekanga zinokuba nzulu. Ukuba ufumana naziphi na kwezi mpawu okanye ezo zidweliswe kwicandelo LESILUMKISO ELIBALULEKILEYO, tsalela umnxeba kwangoko:

• urhudo
• ukungakwazi ukusela ngesiqhelo
• isiyezi
• ukudinwa
• ukuncipha kokuchama
• ubuthathaka
• ukozela
• ukudideka
• ukuhla ukusinda
• ukukhawuleza okanye ukubetha kwentliziyo
• ukudumba kobuso, umqala, ulwimi, imilebe, amehlo, izandla, iinyawo, amaqatha okanye imilenze esezantsi
• ukudinwa
• urhwebo

I-Tolvaptan (Jynarque) inokubangela ezinye iziphumo ebezingalindelekanga. Biza ugqirha wakho ukuba unengxaki engaqhelekanga ngelixa uthatha eli yeza.

Ukuba uhlangabezana neziphumo ebezingalindelekanga ezimandundu, wena okanye ugqirha wakho ungathumela ingxelo kwiNkqubo yoKutya kunye nezoLawulo (i-FDA) yeMedWatch yeNkqubo yokuNgxelo ngezeMeko eziGwenxa kwi-Intanethi (http://www.fda.gov/Safety/MedWatch) okanye ngomnxeba ( 1-800-332-1088).

Gcina eli yeza kwisikhongozeli lifikile, livalekile, kwaye alifumaneki ebantwaneni. Yigcine kubushushu begumbi kwaye kude nobushushu obuninzi kunye nokufuma (hayi kwigumbi lokuhlambela).

Kubalulekile ukugcina onke amayeza ngaphandle kwamehlo kunye nokufikelela kwabantwana njengezikhongozeli ezininzi (ezinje ngeeveki zeepilisi zeveki kunye nezo zamehlo, iikhrim, iipatches, kunye ne-inhalers) azinyangeki kwaye abantwana abancinci banokuzivula ngokulula. Ukukhusela abantwana abancinci kwiityhefu, soloko ukhiya iminqwazi yokhuseleko kwaye ubeke amayeza kwindawo ekhuselekileyo-leyo iphakame kwaye iphakame kwaye ingabonakali kubo kwaye ifikelele kuyo. http://www.upandaway.org

Amayeza angafunekiyo kufuneka achithwe ngeendlela ezizodwa zokuqinisekisa ukuba izilwanyana zasekhaya, abantwana kunye nabanye abantu abanakuzisebenzisa. Nangona kunjalo, akufuneki uligungxule eli yeza kwindlu yangasese. Endaweni yoko, eyona ndlela yokulahla amayeza akho yinkqubo yokubuyisa amayeza. Thetha kumayeza wakho okanye unxibelelane nesebe lakho lenkunkuma / lokurisayikilisha ukuze ufunde malunga neenkqubo zokubuyisa kwindawo ohlala kuyo. Jonga i-FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) ngolwazi oluthe kratya ukuba awunakho ukufikelela kwinkqubo yokubuyisa.

Kwimeko yokugqithisa, fowunela umnxeba wolawulo lwetyhefu kwi-1-800-222-1222. Ulwazi lukwafumaneka kwi-Intanethi kwi-https: //www.poisonhelp.org/help. Ukuba ixhoba liye lawa, laxhuzula, linengxaki yokuphefumla, okanye alikwazi ukuvuswa, ngoko nangoko lifowunele iinkonzo zongxamiseko ngo-911.

Iimpawu zokudlula ngaphezulu zinokubandakanya:

• ukuchama kakhulu
• ukunxanwa ngokugqithiseleyo
• isiyezi
• ukudinwa

Gcina lonke ixesha lokudibana nogqirha wakho kunye nelabhoratri. Ugqirha wakho angayalela iimvavanyo ezithile zebhu ukujonga impendulo yomzimba wakho kwi-tolvaptan (Jynarque).

Musa ukuvumela nabani na ukuba athathe amayeza akho. Buza usokhemesti wakho nayiphi na imibuzo onayo malunga nokuzalisa amayeza akho.

Kubalulekile ukuba ugcine uluhlu olubhaliweyo lwawo onke amayeza owasebenzisayo amayeza owasebenzisayo, kunye nezinye iimveliso ezinjengeevithamini, iiminerali, okanye ezinye izongezo zokutya. Kuya kufuneka uze nolu luhlu qho xa undwendwela ugqirha okanye ungeniswe esibhedlele. Kukwabalulekile ulwazi ukuba uphathe nawe xa kukho imeko kaxakeka.

• Jynarque^®