TECENTRIQ

Country: ইস্রায়েল

ভাষা: ইংরেজি

সূত্র: Ministry of Health

সক্রিয় উপাদান:

ATEZOLIZUMAB

থেকে পাওয়া:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ফার্মাসিউটিকাল ফর্ম:

CONCENTRATE FOR SOLUTION FOR INFUSION

রচনা:

ATEZOLIZUMAB 60 MG / 1 ML

প্রশাসন রুট:

I.V

প্রেসক্রিপশন টাইপ:

Required

Manufactured by:

HOFFMANN LA ROCHE LTD, SWITZERLAND

থেরাপিউটিক ইঙ্গিত:

Urothelial Carcinoma• TECENTRIQ (atezolizumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy and whose tumours have a PD-L1 expression ≥ 5%.• TECENTRIQ is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy.- Non-Small Cell Lung Cancer •TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), as determined by an approved test, with no EGFR or ALK genomic tumor aberrations.•TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin,

অনুমোদন তারিখ:

2019-12-18

তথ্য লিফলেট

וי
ל
י
2022
,ה/רקי ה/אפור
ר
,ה/רקי ת/חקו
לע םכעידוהל תשקבמ מ"עב (לארשי)
הקיטבצמרפ שור תרבח
אפורל ןולעב ועצובש םינוכדע רפסמ
רישכתה לש
קירטנסיט
םיסחייתמה
יאוול תועפות לוהינל
.
ב
.הרמחה םיווהמ רשא םינוכדעו םייתוהמ
םינוכדע קר םיניוצמ וז העדוה
יוותהה
תו
מושרה
תו
ל רישכת
:לארשיב
UROTHELIAL CARCINOMA

TECENTRIQ (atezolizumab) is indicated for the treatment of patients
with locally
advanced or metastatic urothelial carcinoma who are not eligible for
cisplatin-
containing chemotherapy and whose tumours have a PD-L1 expression ≥
5%.

TECENTRIQ is indicated for the treatment of patients with locally
advanced or
metastatic urothelial carcinoma who have disease progression during or
following any
platinum-containing chemotherapy, or within 12 months of neoadjuvant
or adjuvant
chemotherapy
NON-SMALL CELL LUNG CANCER

TECENTRIQ, as a single agent, is indicated for the first-line
treatment of adult patients
with metastatic non-small cell lung cancer (NSCLC) whose tumors have
high PD-L1
expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1
stained tumor-
infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC
≥ 10%]), as
determined by an approved test, with no EGFR or ALK genomic tumor
aberrations.

TECENTRIQ, in combination with bevacizumab, paclitaxel, and
carboplatin, is
indicated for the first-line treatment of adult patients with
metastatic non-squamous
non-small cell lung cancer (NSCLC). In patients with EGFR mutant or
ALK-positive
NSCLC, TECENTRIQ, in combination with bevacizumab, paclitaxel, and
carboplatin,
is indicated only after failure of appropriate targeted therapies.

TECENTRIQ, in combination with paclitaxel protein-bound and
carboplatin, is
indicated for the first-line treatment of adult patients with
metastatic non-squamous
NSCLC with no EGFR or ALK genomic

পণ্য বৈশিষ্ট্য

Tecentriq PI version 11
TECENTRIQ
®
 

ATEZOLIZUMAB
Concentrate for solution for infusion
NAME OF THE MEDICINAL PRODUCT
Tecentriq
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 20 mL of concentrate contains 1,200 mg atezolizumab.
After dilution
_,_
the final concentration of the diluted solution should be between 3.2
and 16.8
mg/mL.
One 14 mL vial of concentrate contains 840 mg of atezolizumab. After
dilution
_,_
the final
concentration of the diluted solution should be between 3.2 and 16.8
mg/mL.
For dilution and other handling recommendations, see section 2.3.
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless to slightly yellowish liquid.
CLINICAL PARTICULARS
Patient safety information card and brochure
The marketing of TECENTRIQ is subject to a risk management plan (RMP)
including patient
safety information materials (patient information card and patient
brochure ). These materials
emphasizes important safety information that the patient should be
aware of before and during
treatment. Please explain to the patient the need to review these
materials before starting
treatment.
1
INDICATIONS AND USAGE
1.1
UROTHELIAL CARCINOMA
●
TECENTRIQ (atezolizumab) is indicated for the treatment of patients
with locally advanced
or metastatic urothelial carcinoma who are not eligible for
cisplatin-containing
chemotherapy and whose tumours have a PD-L1 expression ≥ 5%.
●
TECENTRIQ is indicated for the treatment of patients with locally
advanced or metastatic
urothelial carcinoma who have disease progression during or following
any platinum-
containing chemotherapy, or within 12 months of neoadjuvant or
adjuvant chemotherapy
1.2
NON-SMALL CELL LUNG CANCER
●
TECENTRIQ, as a single agent, is indicated for the first-line
treatment of adult patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors have high
PD-L1 expression
(PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stain