IMFINZI

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

DURVALUMAB

Доступно од:

ASTRAZENECA (ISRAEL) LTD

АТЦ код:

L01XC28

Фармацеутски облик:

SOLUTION FOR INFUSION

Састав:

DURVALUMAB 50 MG/ML

Пут администрације:

I.V

Тип рецептора:

Required

Произведен од:

CATALENT INDIANA LLC, USA

Терапеутска област:

DURVALUMAB

Терапеутске индикације:

Urothelial Carcinoma IMFINZI is indicated for the treatment of patients with PD-L1 high (Tumor cell ≥25% or IC ≥25%) 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. Non-Small Cell Lung Cancer - IMFINZI is indicated for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.- IMFINZI in combination with tremelimumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic NSCLC with no sensitising EGFR mutations or ALK positive mutations.Small Cell Lung Cancer IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).Biliary Tract CancersIMFINZI in combination with gemcitabine and cisplatin is indicated for the first-line treatment of adults with locally advanced, unresectable, or metastatic biliary tract cancer (BTC).Hepatocellular CarcinomaIMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).

Датум одобрења:

2023-01-31

Информативни летак

1
לפוטמל בושח עדימ
ל"מ 2.4/ג"מ 120 יזניפמיא
ל"מ 10/ג"מ 500 יזניפמיא
)באמולאברוד(
جلاعتملل ةماه تامولعم
للم 2.4/غلم 120 يزنيفميإ
للم 10/غلم 500 يزنيفميإ
)بامولاﭬرود(
2
3
לפוטמל בושח עדימ
יאוול תועפותל םורגל הלולע באמולאברוד
• •
.ידימ לופיט תושרודה תורומח
.תוירשפא יאוול תועפותל בל םישל ךילע
••
תא עונמל עייסי יאוול תועפותב םדקומ
לופיט
• •
.ןתרמחה
םייונישב ןיחבמ ךנה םא אפורל דימ חווד
• •
תועפותמ תחא לכמ לבוס ךנה םא וא ךפוגב
.לפוטמל עדימה סיטרכב תומושרה יאוולה
.ךמצעב יאוולה תועפותב לפטל הסנת לא אנא
••
רפסמ דע שחרתהל תולולע יאוולה תועפות •
•
.לופיטה םויס רחאל םישדוח
עדימה סיטרכ תא ןמז לכב ךמע אש • •
ךל קינעמה אפור לכל ותוא הארהו לפוטמל
.לופיט
הנפ אנא ,הז לופיט יבגל תולאש ךל שי םא
• •
.לפטמה אפורל
4
יאופרה תווצל בושח עדימ
היפרתונומיא לופיט תחת אצמנ הז לפוטמ •
•
.באמולאברוד הפורתה םע
תוחתפתהל ןוכיסה תא ריבגמ באמולאברוד
• •
.תויגולונומיא יאוול תועפות
שחרתהל תולולע תויגולונומיא יאוול
תועפות
• •
רחאל םישדוח רפסמו לופיטה ךרוא לכל
.ומויס
רועזמל םיינויח םניה לופיטו םדקומ
ןוחבא
• •
.םירומח םינוכיס
םע תוצעייתה ינפל הז הלוחב לפטל ןיא
• •
םא אלא ,לפוטמה לש גולוקנואה אפורה
.יאופר םוריח הרקמב רבודמ
5
דרשמ ידי לע רשואו קדבנ הז סיטרכ"
"2020 יאמב תוא

Карактеристике производа

1
Imfinzi
®
Durvalumab 50 mg/1ml
Solution for infusion
1.
INDICATIONS AND USAGE
1.1
Urothelial Carcinoma
IMFINZI is indicated for the treatment of patients with PD-L1 high
(Tumor cell 25% or IC
25%)
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.
1.2
Non-Small Cell Lung Cancer
-
IMFINZI is indicated for the treatment of patients with unresectable
Stage III non-small cell lung
cancer (NSCLC) whose disease has not progressed following concurrent
platinum-based
chemotherapy and radiation therapy.
-
IMFINZI in combination with tremelimumab and platinum-based
chemotherapy is indicated for
the first-line treatment of adults with metastatic NSCLC with no
sensitising EGFR mutations or
ALK positive mutations.
Patient safety information card
The marketing of Imfinzi is subject to a risk management plan (RMP)
including a 'patient alert card'.
The 'patient alert card', emphasizes important safety information that
the patient should be aware of
before and during treatment. Please explain to the patient the need to
review the card before
starting treatment.
2
1.3
Small Cell Lung Cancer
IMFINZI, in combination with etoposide and either carboplatin or
cisplatin, is indicated for the first-
line treatment
of adult patients with extensive-stage small cell lung cancer
(ES-SCLC).
1.4 Biliary Tract Cancers
IMFINZI in combination with gemcitabine and cisplatin is indicated for
the first-line treatment of
adults with locally advanced, unresectable, or metastatic biliary
tract cancer (BTC)
1.5 Hepatocellular Carcinoma
IMFINZI in combination with tremelimumab is indicated for the first
line treatment of adults with advanced
or unresectable hepatocellular carcinoma (HCC).
2.
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosage
The recommended dosages for IMFINZI as a single agent and IMFINZI in
combination with other therapeutic ag