Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
PERTUZUMAB
ROCHE PHARMACEUTICALS (ISRAEL) LTD
L01FD02
CONCENTRATE FOR SOLUTION FOR INFUSION
PERTUZUMAB 420 MG / 14 ML
I.V
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
PERTUZUMAB
PERTUZUMAB
Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy for: • The neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. • the adjuvant treatment of patients with HER2-positive early breast cancer (node positive) at high risk of recurrence .Metastatic Breast CancerPerjeta is indicated for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
2018-01-31
Page 1 of 2 Perjeta ® Vials 420mg/14ml יאמ 2019 /14ML 420MG ® PERJETA הט'גרפ 420 / ג"מ 14 ל"מ PERTUZUMAB CONCENTRATE FOR SOLUTION FOR INFUSION _ _ ,ה/רקי ת/חקור ,ה/רקי ה/אפור מ"עב )לארשי( הקיטבצמרפ שור תרבח תשקבמ םינוכדע רפסמ לע םכעידוהל לש אפורל ןולעב רישכתה הט'גרפ םינוכדע קר םיניוצמ וז העדוהב . .הרמחה םיווהמ רשא םינוכדעו םייתוהמ יוותהה תו ה מושר תו ל רישכת :לארשיב METASTATIC BREAST CANCER: Perjeta is indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2 positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. EARLY BREAST CANCER: Perjeta is indicated for use in combination with trastuzumab and docetaxel for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or arly stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall. Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (positive nodes). :רבסה יתחת וק םע טסקט .ןולעל ףסוהש טסקט ןייצמ הצוח וק םע טסקט .ןולעה ןמ רסוהש טסקט ןייצמ .תואירבה דרשמ י"ע רשואש יפכ אפורל ןולעב ןייעל שי ףסונ עדימל ןכדועמה ןולעה חלשנ לבקל ןתינו ,תואירבה דרשמ רתאבש תופורתה רגאמב םוסרפל ו ספדומ י"ע שור :םושירה לעבל היינפ ד.ת ,מ"עב )לארשי( הקיטבצמרפ 6391 ןורשה Perskaitykite visą dokumentą
EMEA/H/C/0002547/II/0066 (05.2023) 1 Perjeta PI_Ver 9.0 PERJETA_PI_VER 9.0 PERJETA ® _PERTUZUMAB_ Concentrate for solution for infusion 1. NAME OF THE MEDICINAL PRODUCT Perjeta 420 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 ml vial of concentrate contains 420 mg of pertuzumab at a concentration of 30 mg/ml. After dilution, one ml of solution contains approximately 3.02 mg of pertuzumab for the initial dose and approximately 1.59 mg of pertuzumab for the maintenance dose (see section 6.6). Pertuzumab is a humanised IgG1 monoclonal antibody produced in mammalian (Chinese hamster ovary) cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear to slightly opalescent, colourless to pale yellow, liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Early breast cancer Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. Perjeta is indicated for use in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence (positive nodes). Metastatic Breast Cancer Perjeta is indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2 positive metastatic breast cancer _ _ who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Perjeta should only be initiated under the supervision of a physician experienced in the administration of anti-cancer agents. Perjeta should be administered by a healthcare professional prepared to manage anaphylaxis and in an environment where full resuscitation facilities are immediately avai Perskaitykite visą dokumentą