תבנית:תרופה/אופדיבו - Opdivo: הבדלים בין גרסאות
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מ (החלפת טקסט – "|שם בעל הרישום=בעל רישום::BRISTOL - MYERS SQUIBB, ISRAEL " ב־"|שם בעל הרישום=BRISTOL - MYERS SQUIBB, ISRAEL ") |
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שורה 3: | שורה 3: | ||
|שם באנגלית={{{שם באנגלית|Opdivo}}} | |שם באנגלית={{{שם באנגלית|Opdivo}}} | ||
|מרכיב פעיל= | |מרכיב פעיל= | ||
− | + | [[Nivolumab]] 10MG/ML {{כ}}[[L01XC17]] | |
|קבוצה פרמקולוגית (ATC)= | |קבוצה פרמקולוגית (ATC)= | ||
{{ATC משרד הבריאות|L01XC|Monoclonal antibodies}} | {{ATC משרד הבריאות|L01XC|Monoclonal antibodies}} | ||
שורה 10: | שורה 10: | ||
|סל הבריאות=כלול בסל | |סל הבריאות=כלול בסל | ||
|במרשם=כן | |במרשם=כן | ||
− | |התוויה= | + | |התוויה= |
− | + | <div style="direction:ltr;"> | |
− | + | Unresectable or Metastatic Melanoma:Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced(unresectable or metastatic) melanoma in adults.Adjuvant Treatment of Melanoma:Opdivo is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resectionMetastatic Non-Small Cell Lung Cancer:- Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.- Opdivo is indicated for the treatment of patients with metastatic non small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Renal Cell Carcinoma:Opdivo as a single agent is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.Opdivo in combination with ipilimumab is indicated for the first line treatment of patients with intermediate or poor risk, advanced renal cell carcinoma (RCC).-OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced RCCClassical Hodgkin Lymphoma:Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous HSCT.Squamous Cell Carcinoma of the Head and Neck:Opdivo is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient(dMMR) Metastatic Colorectal Cancer:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Urothelial carcinoma:OPDIVO is indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.Opdivo (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:- have disease progression during or following platinum-containing chemotherapy- have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.- Hepatocellular Carcinoma:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.Small Cell Lung Cancer (SCLC):Opdivo is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum based chemotherapy and at least one other line of therapy.Esophageal carcinoma:--OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).-OPDIVO is indicated for the treatment of patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapyMalignant Pleural MesotheliomaOPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma | |
− | + | </div> | |
− | + | |שם יצרן=[[BRISTOL - MYERS SQUIBB HOLDINGS PHARMA, LTD, LIABILITY COMPANY, USA]] | |
− | + | ||
− | + | ||
− | + | ||
− | |שם יצרן= | + | |
|שם יצרן מקוצר=[[BRISTOL MYERS SQUIBB]] | |שם יצרן מקוצר=[[BRISTOL MYERS SQUIBB]] | ||
|שם בעל הרישום=[[BRISTOL - MYERS SQUIBB, ISRAEL]] | |שם בעל הרישום=[[BRISTOL - MYERS SQUIBB, ISRAEL]] | ||
|רישיון מתאריך={{{רישיון מתאריך|[[רישום מתאריך::03/2015]]}}} | |רישיון מתאריך={{{רישיון מתאריך|[[רישום מתאריך::03/2015]]}}} | ||
|תאריך הגשה=10/2014 | |תאריך הגשה=10/2014 | ||
− | |קישור למאגר משרד הבריאות1= | + | |קישור למאגר משרד הבריאות1=[https://israeldrugs.health.gov.il/#!/medDetails/153%2055%2034333%2000 אופדיבו] במאגר משרד הבריאות |
− | |עלון לרופא={{ | + | |עלון לרופא={{רווח קשיח}} |
− | |עלון לצרכן={{ | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_356472721.pdf עלון לרופא 14.01.2021] |
− | |החמרות לעלון={{ | + | |עלון לצרכן={{רווח קשיח}} |
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_576694121.pdf עלון לצרכן עברית 30.01.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_576690621.pdf עלון לצרכן ערבית 30.01.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_576692521.pdf עלון לצרכן אנגלית 30.01.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528215421.pdf כרטיס מידע בטיחותי למטופלים רוסית 05.07.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528214821.pdf כרטיס מידע בטיחותי למטופלים עברית 05.07.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528213821.pdf כרטיס מידע בטיחותי למטופלים אנגלית 05.07.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528213221.pdf כרטיס מידע בטיחותי למטופלים ערבית 05.07.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528210221.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי רוסית 05.07.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528208821.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי עברית 05.07.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528207021.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי אנגלית 05.07.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_20_528205221.pdf חוברת מידע בטיחותי למטופל/הורי מטופל/מטפל עיקרי ערבית 05.07.2021] | ||
+ | |החמרות לעלון={{רווח קשיח}} | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_356472921.pdf החמרה לעלון 14.01.2021] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_17_463259820.pdf החמרה לעלון 26.11.2020] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_16_320275020.pdf החמרה לעלון 31.05.2020] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_11_477543119.pdf החמרה לעלון 17.04.2019] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_11_472054619.pdf החמרה לעלון 17.04.2019] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_7_60299118.pdf החמרה לעלון לרופא 26.03.2018] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ArcRishum01_6_164207116.pdf החמרה לעלון 19.06.2016] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ArcRishum01_8_165463116.pdf החמרה לעלון 01.12.2015] | ||
+ | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ArcRishum01_10_166479416.doc החמרה לעלון 22.05.2015] {{DOC}} | ||
|מספר רישום={{{מספר רישום|153 55 34333 00}}} | |מספר רישום={{{מספר רישום|153 55 34333 00}}} | ||
|תאריך עדכון=[[עדכון אחרון::15/07/15]] | |תאריך עדכון=[[עדכון אחרון::15/07/15]] | ||
− | |תמונת אריזה= | + | |תמונת אריזה= |
|שיווק הופסק={{{שיווק הופסק|לא}}} | |שיווק הופסק={{{שיווק הופסק|לא}}} | ||
− | |שם ללא מינון= | + | |שם ללא מינון=אופדיבו - Opdivo |
+ | |שם ללא מינון באנגלית=Opdivo | ||
+ | |התאמת מינון= | ||
+ | |התוויות נגד= | ||
+ | |פרמקודינמיקה= | ||
+ | |פרמקוקינטיקה= | ||
+ | |שימוש בהריון והנקה= | ||
+ | |תגובות בין תרופתיות= | ||
+ | |תופעות לוואי= | ||
+ | |חיפוש בוויקירפואה= | ||
|ללא קטגוריה={{{ללא קטגוריה|<noinclude>-</noinclude>}}} | |ללא קטגוריה={{{ללא קטגוריה|<noinclude>-</noinclude>}}} | ||
}} | }} | ||
<noinclude>{{תרופה/תיעוד}}</noinclude> | <noinclude>{{תרופה/תיעוד}}</noinclude> |
גרסה מתאריך 07:43, 30 בינואר 2022
![RxIcon.png](/images/7/72/RxIcon.png)
קבוצה פרמקולוגית (ATC4) | L01XC Monoclonal antibodies |
---|---|
מרכיב פעיל (ATC5) | Nivolumab 10MG/ML L01XC17 |
צורת מתן | תוך-ורידי - I.V |
צורת מינון | תרכיז להכנת תמיסה לאינפוזיה, CONCENTRATE FOR SOLUTION FOR INFUSION למניעת מינון יתר או הרעלה יש ליטול את התרופה בהתאם למינון המומלץ כפי שמופיע בעלון לצרכן |
התוויה | Unresectable or Metastatic Melanoma:Opdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced(unresectable or metastatic) melanoma in adults.Adjuvant Treatment of Melanoma:Opdivo is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resectionMetastatic Non-Small Cell Lung Cancer:- Opdivo, in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.- Opdivo is indicated for the treatment of patients with metastatic non small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.Renal Cell Carcinoma:Opdivo as a single agent is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.Opdivo in combination with ipilimumab is indicated for the first line treatment of patients with intermediate or poor risk, advanced renal cell carcinoma (RCC).-OPDIVO, in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced RCCClassical Hodgkin Lymphoma:Opdivo is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after:* autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or* 3 or more lines of systemic therapy that includes autologous HSCT.Squamous Cell Carcinoma of the Head and Neck:Opdivo is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient(dMMR) Metastatic Colorectal Cancer:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of adult and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.Urothelial carcinoma:OPDIVO is indicated for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.Opdivo (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:- have disease progression during or following platinum-containing chemotherapy- have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.- Hepatocellular Carcinoma:Opdivo, as a single agent or in combination with ipilimumab, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.Small Cell Lung Cancer (SCLC):Opdivo is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum based chemotherapy and at least one other line of therapy.Esophageal carcinoma:--OPDIVO is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).-OPDIVO is indicated for the treatment of patients with unresectable, advanced, recurrent or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapyMalignant Pleural MesotheliomaOPDIVO, in combination with ipilimumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma OPDIVO, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma |
תבנית:נתוני סל/תרופה/אופדיבו - Opdivo | |
עלון לרופא והחמרות לעלון |
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ערכים בוויקירפואה | ערכים קשורים בוויקירפואה |
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אופדיבו במאגר משרד הבריאות |
חיפוש מאמרים | - |
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מידע ברשת | - |
שם יצרן | BRISTOL - MYERS SQUIBB HOLDINGS PHARMA, LTD, LIABILITY COMPANY, USA |
שם בעל הרישום | BRISTOL - MYERS SQUIBB, ISRAEL |
רישיון | תאריך הגשה: 10/2014. רישיון מתאריך: 03/2015 |
תאריך עדכון אחרון | 15/07/15 |
דף זה נוצר על ידי בוט ומגדיר תבנית עם פרטי התרופה.
- דף התרופה: אופדיבו - Opdivo
- לדריסה ידנית של פרטי התרופה: ניתן לערוך את דף התרופה לעיל. לדוגמה החליפו את:
{{תרופה/אופדיבו - Opdivo}}
ב:
{{תרופה/אופדיבו - Opdivo | שם הפרמטר=ערך חדש (דורס את הערך שהבוט הגדיר) }}