YERVOY 5 MGML

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

IPILIMUMAB

متاح من:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC رمز:

L01XC11

الشكل الصيدلاني:

CONCENTRATE FOR SOLUTION FOR INFUSION

تركيب:

IPILIMUMAB 5 MG/ML

طريقة التعاطي:

I.V

نوع الوصفة الطبية :

Required

المصنعة من قبل:

BRISTOL MYERS SQUIBB COMPANY, USA

المجموعة العلاجية:

IPILIMUMAB

المجال العلاجي:

IPILIMUMAB

الخصائص العلاجية:

Unresectable or Metastatic MelanomaYervoy (ipilimumab) is indicated for the treatment of adult patients with advanced (unresectable or metastatic) melanoma. Yervoy in combination with nivolumab is indicated for the treatment of adult and pediatric patients 12 years and older with advanced (unresectable or metastatic) melanoma . Advanced Renal Cell CarcinomaYERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with intermediate or poor risk, advanced renal cell carcinoma (RCC). Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Metastatic Colorectal CancerYERVOY, in combination with nivolumab, is indicated for the treatment of adult and pediatric patients 12 years of age 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.Metastatic Non-Small Cell Lung CancerYERVOY, in combination with nivolumab 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.Hepatocellular CarcinomaYervoy, in combination with nivolumab, is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) Child-Pugh A who have been previously treated with sorafenib.Malignant Pleural MesotheliomaYERVOY, in combination with nivolumab, is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesotheliomaEsophageal cancerYervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.

تاريخ الترخيص:

2017-02-28

نشرة المعلومات

7356-IL-2300004 01/23
.ילש גולוקנואל רשקתהל אנ
:ארקנה יפרתונומיא לופיט יתלביק
Please call my oncologist.
I have received an immunotherapy called:
םש
:ת/לפוטמה
:)םי(רישכתה םש
)םיאתמה תא ןמס(
םש
:גולוקנואה
ןופלט רפסמ
:גולוקנואה לש
OPDIVO®/YERVOY®/OPDIVO® + YERVOY®
© 2023 Bristol-Myers Squibb Company. All rights reserved.
תוארוהל םאתהב רשוא הז סיטרכ
2023 ראוניב תואירבה דרשמ
Present this card EVERY TIME you visit a healthcare provider
בל םיש רשקתה גולוקנואה אפורל
לפוטמה לש תומרגנה יאוול תועפותב לופיטל השיגה הנוש תויהל היושע היפרתונומיאמ
ןטרסל םירחא םילופיטמ לפוטמל לופיט תקנעה םע ןיתמהל ןיא
ףוחד לופיט שרדנש הרקמב
בושח
תויחא/םיאפור רובע עדימ
.יובריי לשו ובידפוא לש ילארשיה אפורל
ןולעב ןייעל שי ףסונ עדימל
יאוול תועפות לע חווידל ןווקמה ספוטה
תועצמאב תואירבה דרשמל יאוול תועפות לע
חוודל ןתינ
:רושיקל הסינכ ידי לע וא www.health.gov.il
:תואירבה דרשמ רתא לש תיבה ףדב אצמנש
https://sideeffects.health.gov.il
1 דצ
2 דצ

خصائص المنتج

1
Yervoy_NPI_Jan2024
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
YERVOY 5 MG/ML
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of concentrate contains 5 mg ipilimumab.
One 10 ml vial contains 50 mg of ipilimumab.
One 40 ml vial contains 200 mg of ipilimumab.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
PATIENT POCKET GUIDE AND PATIENT WALLET CARD_ _
The marketing of Yervoy is subject to a risk management plan (RMP)
including a
‘
patient pocket
guide
’
together with a
‘
patient wallet card
’
(Patient safety information card). The Patient Pocket
Guide and Wallet Card emphasize important safety information that the
patient should be aware
of before and during treatment.
Please ensure you are familiar with this important information and
explain to the patient the need
to review the patient pocket guide and the patient wallet card before
starting treatment.
1
INDICATIONS AND USAGE
1.1
UNRESECTABLE OR METASTATIC MELANOMA
•
YERVOY (ipilimumab) is indicated for the treatment of adult patients
with advanced
(unresectable or metastatic) melanoma.
•
YERVOY, in combination with nivolumab, is indicated for the treatment
of adult and
pediatric
patients
12
years
and
older
with
advanced
(unresectable
or
metastatic)
melanoma.
2
Yervoy_NPI_Jan2024
1.2
ADVANCED RENAL CELL CARCINOMA
YERVOY, in combination with nivolumab, is indicated for the first-line
treatment of adult
patients with intermediate or poor risk, advanced renal cell carcinoma
(RCC).
1.3
MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT
METASTATIC COLORECTAL CANCER
YERVOY, in combination with nivolumab, is indicated for the treatment
of adult and pediatric
patients 12 years of age 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.
1.4
HEPATOCELLULAR CARCINOMA
YERVOY, in combination with nivolumab, is indicated for the treatment
of adult patients with