תבנית:תרופה/אוויפלרה - Eviplera: הבדלים בין גרסאות

|במרשם={{{במרשם|כן}}}

|במרשם={{{במרשם|כן}}}

|התוויה={{{התוויה|<div style="direction:ltr;">EVIPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).The following points should be considered when initiating therapy with EVIPLERA in adult patients with no antiretroviral treatment history: • More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ?50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [See Clinical Studies (14)]. • Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3 [See Clinical Studies (14)]. • The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [See Microbiology (12.4)]• More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology (12.4)].</div>}}}

|התוויה={{{התוויה|<div style="direction:ltr;">EVIPLERA, a combination of two nucleoside analog HIV 1 reverse transcriptase inhibitors (emtricitabine and tenofovir disoproxil fumarate) and one non-nucleoside reverse transcriptase inhibitor (rilpivirine), is indicated for use as a complete regimen for the treatment of HIV-1 infection in adult patients with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and in certain virologically-suppressed (HIV-1 RNA <50 copies/mL) adult patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see below).The following points should be considered when initiating therapy with EVIPLERA in adult patients with no antiretroviral treatment history: • More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ?50 copies/mL) compared to rilpivirine-treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL [See Clinical Studies (14)]. • Regardless of HIV-1 RNA level at the start of therapy, more rilpivirine-treated subjects with CD4+ cell count less than 200 cells/mm3 experienced virologic failure compared to rilpivirine-treated subjects with CD4+ cell count greater than or equal to 200 cells/mm3 [See Clinical Studies (14)]. • The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz [See Microbiology (12.4)]• More subjects treated with rilpivirine developed tenofovir and lamivudine/emtricitabine associated resistance compared to efavirenz [See Microbiology (12.4)].</div>}}}

|שם יצרן={{{שם יצרן|[[יצרן::JANSSEN CILAG S.P.A., ITALY]]}}}

|שם יצרן={{{שם יצרן|[[יצרן::JANSSEN CILAG S.P.A., ITALY]]}}}

|שם יצרן מקוצר=[[שם יצרן מקוצר::JANSSEN| ]]

|שם יצרן מקוצר=[[שם יצרן מקוצר::JANSSEN| ]]

|תאריך הגשה={{{תאריך הגשה|[[תאריך הגשה::07/2014]]}}}

|תאריך הגשה={{{תאריך הגשה|[[תאריך הגשה::07/2014]]}}}

|קישור למאגר משרד הבריאות1={{{קישור למאגר משרד הבריאות1|{{מסחרי משרד הבריאות|Eviplera|אוויפלרה}}}}}

|קישור למאגר משרד הבריאות1={{{קישור למאגר משרד הבריאות1|{{מסחרי משרד הבריאות|Eviplera|אוויפלרה}}}}}

|החמרות לעלון={{{החמרות לעלון|[http://www.old.health.gov.il/units/pharmacy/trufot/alonim/Eviplera_spc_pil_Jul_2014_1406454405382.doc החמרה לעלון]}}}

|החמרות לעלון={{{החמרות לעלון|[http://www.old.health.gov.il/units/pharmacy/trufot/alonim/Eviplera_spc_pil_Jul_2014_1406454405382.doc החמרה לעלון]}}}

|מספר רישום={{{מספר רישום|149 30 33766 02}}}

|מספר רישום={{{מספר רישום|149 30 33766 02}}}

|תמונת אריזה={{{תמונת אריזה|}}}

|תמונת אריזה={{{תמונת אריזה|}}}

|שיווק הופסק={{{שיווק הופסק|לא}}}

|שיווק הופסק={{{שיווק הופסק|לא}}}