국가: 이스라엘
언어: 영어
출처: Ministry of Health
BRENTUXIMAB VEDOTIN
TAKEDA ISRAEL LTD
L01XC12
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BRENTUXIMAB VEDOTIN 50 MG/VIAL
I.V
Required
TAKEDA PHARMA A/S, DENMARK
BRENTUXIMAB VEDOTIN
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following ASCT. ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy . ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.ADCETRIS is indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.
2019-05-31
Takeda Israel Ltd. 25 Efal st., P.O.B 4140, Petach-Tikva 4951125 Tel:+972-3-3733140 Fax (local) : + 972-3-3733150 יאמ 2023 אפור / ה , חקור / ת דבכנ / ה , :ןודנה (brentuximab vedotin) 50mg ® ETRIS ADC ןוכדע אפורל ןולעה מ"עב לארשי הדקט תרבח מ עדיל תשקב יכ ןכדוע ןודנבש רישכתה לש אפורל ןולעה הנורחאל . וותה תוי תומושרה הז רישכתל : 1. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1) following autologous stem cell transplant (ASCT) or 2) following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. 2. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). 3. ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following ASCT. 4. ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy. 5. ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine. 6. ADCETRIS is indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. :ליעפ ביכרמ brentuximab vedotin 50 mg/vial ןלהל טוריפ םייונישה םיירקיעה ולעב ורל ן אפ ) טסקט ףסונש ןמוסמ וחכב ל , סקט ט טמשוהש ןמוסמ טסקטכ םודא םע וק הצוח , מחה הווהמה טסקט בוהצב שגדומ הר ( : 4.8 Undesirable effects … _Monotherapy _ 전체 문서 읽기
1 1. NAME OF THE MEDICINAL PRODUCT ADCETRIS ® 50 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg of brentuximab vedotin. After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin. ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE). Excipient with known effect Each vial contains approximately 13.2 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white cake or powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Hodgkin lymphoma ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine. ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1). ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Systemic anaplastic large cell lymphoma and Peripheral T-cell lymphomas (PTCL) ADCETRIS is indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL. 2 Cutaneous T-cell lymphoma AD 전체 문서 읽기