国: イスラエル
言語: 英語
ソース: Ministry of Health
ATEZOLIZUMAB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
CONCENTRATE FOR SOLUTION FOR INFUSION
ATEZOLIZUMAB 60 MG / 1 ML
I.V
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
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,
2019-12-18
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 完全なドキュメントを読む
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 完全なドキュメントを読む