לינפארזה 150 מ"ג - Lynparza 150 mg: הבדלים בין גרסאות
מתוך ויקיתרופות
(יצירת דף עם התוכן "{{תרופה |שם בעברית=לינפארזה 150 מ"ג |שם באנגלית=Lynparza 150 mg |שם ללא מינון=לינפארזה - Lynparza |שם ללא ...") |
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| שורה 19: | שורה 19: | ||
|התוויה= | |התוויה= | ||
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| − | Ovarian cancer:Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.First-line Maintenance Treatment of Advanced Ovarian Cancer in Combination with BevacizumabLynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:• a deleterious or suspected deleterious BRCA mutation, and/or• genomic instability Breast cancer:Germline BRCA-mutated HER2-negative Metastatic Breast CancerLynparza is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.Adjuvant Treatment of Germline BRCA-mutated HER2-negative High Risk Early Breast Cancer Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Adenocarcinoma of the pancreas:First-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic AdenocarcinomaLynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.Prostate cancer:germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate | + | Ovarian cancer:Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.First-line Maintenance Treatment of Advanced Ovarian Cancer in Combination with BevacizumabLynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:• a deleterious or suspected deleterious BRCA mutation, and/or• genomic instability Breast cancer:Germline BRCA-mutated HER2-negative Metastatic Breast CancerLynparza is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.Adjuvant Treatment of Germline BRCA-mutated HER2-negative High Risk Early Breast Cancer Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Adenocarcinoma of the pancreas:First-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic AdenocarcinomaLynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.Prostate cancer:• germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancer Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.• Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious HRR-mutated (HRRm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an approved companion diagnostic for Lynparza |
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|ללא קטגוריה= | |ללא קטגוריה= | ||
|במרשם=כן | |במרשם=כן | ||
|עלון לרופא={{רווח קשיח}} | |עלון לרופא={{רווח קשיח}} | ||
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_39925624.pdf עלון לרופא 31.12.2023] |
|עלון לצרכן={{רווח קשיח}} | |עלון לצרכן={{רווח קשיח}} | ||
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_2_309185022.pdf עלון לצרכן עברית 23.01.2022] | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_2_309185022.pdf עלון לצרכן עברית 23.01.2022] | ||
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_941370022.pdf עלון לצרכן עברית 27.07.2022] | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_941370022.pdf עלון לצרכן עברית 27.07.2022] | ||
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_11_548237623.pdf עלון לצרכן עברית 30.11.2023] |
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_377390121.pdf עלון לצרכן אנגלית Patient information leaflet{{כ}} 24.11.2020] | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_377390121.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 24.11.2020] |
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_757816921.pdf עלון לצרכן אנגלית Patient information leaflet{{כ}} 21.04.2021] | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_757816921.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 21.04.2021] |
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_43345624.pdf עלון לצרכן אנגלית - Patient information leaflet{{כ}} 30.11.2023] |
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_377389521.pdf עלון לצרכן ערבית نشرة للمستهلك باللغة العربية 24.11.2020] | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_19_377389521.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 24.11.2020] |
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_757813221.pdf עלון לצרכן ערבית نشرة للمستهلك باللغة العربية 21.04.2021] | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum_21_757813221.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 21.04.2021] |
| − | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/ | + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_13_43345824.pdf עלון לצרכן ערבית - نشرة للمستهلك باللغة العربية 30.11.2023] |
|החמרות לעלון={{רווח קשיח}} | |החמרות לעלון={{רווח קשיח}} | ||
| + | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_9_270038923.pdf החמרה לעלון 31.08.2023] | ||
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_899071522.pdf החמרה לעלון 30.08.2022] | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_5_899071522.pdf החמרה לעלון 30.08.2022] | ||
*[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_3_786216722.pdf החמרה לעלון 11.05.2022] | *[https://mohpublic.z6.web.core.windows.net/IsraelDrugs/Rishum01_3_786216722.pdf החמרה לעלון 11.05.2022] | ||
| שורה 44: | שורה 45: | ||
|קבוצה פרמקולוגית (ATC)={{ATC משרד הבריאות|L01XX|Other antineoplastic agents}} | |קבוצה פרמקולוגית (ATC)={{ATC משרד הבריאות|L01XX|Other antineoplastic agents}} | ||
|רישיון מתאריך= | |רישיון מתאריך= | ||
| − | |שיווק הופסק= | + | |שיווק הופסק=לא |
| − | |תאריך עדכון= | + | |תאריך עדכון=22/05/2024 |
|התאמת מינון= | |התאמת מינון= | ||
|התוויות נגד= | |התוויות נגד= | ||
גרסה אחרונה מתאריך 16:19, 22 במאי 2024
נתוני תרופה
במרשם 
| מינונים נוספים | |||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| קבוצה פרמקולוגית (ATC4) | L01XX Other antineoplastic agents | ||||||||||||||||||||||||||||||||||||||||||||||||
| מרכיב פעיל (ATC5) | |||||||||||||||||||||||||||||||||||||||||||||||||
| צורת מתן | פומי - PER OS | ||||||||||||||||||||||||||||||||||||||||||||||||
| צורת מינון | טבליות מצופות פילם, FILM COATED TABLETS למניעת מינון יתר או הרעלה יש ליטול את התרופה בהתאם למינון המומלץ כפי שמופיע בעלון לצרכן | ||||||||||||||||||||||||||||||||||||||||||||||||
| התוויה | Ovarian cancer:Lynparza is indicated as monotherapy for the: • maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2- mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. • Maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.First-line Maintenance Treatment of Advanced Ovarian Cancer in Combination with BevacizumabLynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:• a deleterious or suspected deleterious BRCA mutation, and/or• genomic instability Breast cancer:Germline BRCA-mutated HER2-negative Metastatic Breast CancerLynparza is indicated in patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)- positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.Adjuvant Treatment of Germline BRCA-mutated HER2-negative High Risk Early Breast Cancer Lynparza is indicated for the adjuvant treatment of adult patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Adenocarcinoma of the pancreas:First-line Maintenance Treatment of Germline BRCA-mutated Metastatic Pancreatic AdenocarcinomaLynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.Prostate cancer:• germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancer Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA1/2 or ATM- mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone.• Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious HRR-mutated (HRRm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an approved companion diagnostic for Lynparza | ||||||||||||||||||||||||||||||||||||||||||||||||
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| עלון לרופא והחמרות לעלון |
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| ערכים בוויקירפואה | ערכים קשורים בוויקירפואה |
|---|---|
| לינפארזה 150 מ"ג במאגר משרד הבריאות |
| חיפוש מאמרים | מאמרים ב-PubMed |
|---|---|
| מידע ברשת | RxList WebMD Drugs.com |
| שם יצרן | ASTRA ZENECA UK LIMITED |
| שם בעל הרישום | ASTRA ZENECA (ISRAEL) LTD |
| רישיון | תאריך הגשה: 2/2018. רישיון מתאריך: |
| תאריך עדכון אחרון | 22/05/2024 |
תמונת אריזה
