País: Israel
Idioma: inglés
Fuente: Ministry of Health
BORTEZOMIB
J-C HEALTH CARE LTD
L01XX32
POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB 3.5 MG
I.V, S.C
Required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
BORTEZOMIB
BORTEZOMIB
Velcade (bortezomib) for injection is indicated for the treatment of patients with multiple myeloma.Velcade (bortezomib) for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
2014-08-31
J-C Health Care Ltd. Kibbutz Shefayim 6099000, ISRAEL tel +972-9-959-1111 fax +972-9-958-3636 Kibbutz Shefayim, 6099000 ISRAEL Phone: 09-9591111 Fax: 09-9583636 בפ ראור 2021 ה/דבכנ ה/אפור ה/דבכנ ת/חקור וננוצרב איבהל םכתעידיל א ת ש אפורל ןולעב םינוכדעה רישכתה ל : _VELCADE 3.5MG POWDER FOR SOLUTION FOR INJECTION 131-60-3139-01/02/03_ _ _ :תויוותהל םושרה Velcade (bortezomib) for injection is indicated for the treatment of patients with multiple myeloma. Velcade (bortezomib) for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Velcade in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation. םייוניש ולח םיבחרנ ל ןולעב .אפור ב"צמ םייקנה םיצבקה ל חא טוריפ תא תוארל תנמ לע .םייונישה ר פל ןתינ םייונישה דרשמ רתאבש עדימה רגאמל תונ תבותכב תואירבה !/byDrug x.html# inde rugs/ ov.il/d https://data.health.g . םינולעה חלשנ ו וסרפל ם אולמב ם ל רתה רגאמ תופו ש .תואירבה דרשמ רתאב ןכ ומכ , לבקל ןתינ ם פדומ ס םי ב ונילא הינפ ל ןופלט 09-9591111 . ,הכרבב ןהכ רירפצ נוממ חקור ה Leer el documento completo
Page 1 of 41 Velcade 3.5mg_PI_Jun2022_Ref_USPI Oct2021 & EU SmPC Feb2021 FULL PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT VELCADE 3.5MG 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3.5 mg of BORTEZOMIB (as a mannitol boronic ester). After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib. After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib. For the full list of excipients, see section 12. Powder for solution for injection I.V., S.C. 3 THERAPUETIC INDICATIONS 3.1 MULTIPLE MYELOMA VELCADE is indicated for the treatment of adult patients with multiple myeloma. 3.2 MANTLE CELL LYMPHOMA VELCADE (bortezomib) for Injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation. 4 DOSAGE AND ADMINISTRATION GENERAL DOSING GUIDELINES VELCADE IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. VELCADE must not be administered by any other route. Intrathecal administration has resulted in death. Intrathecal administration has resulted in death. BECAUSE EACH ROUTE OF ADMINISTRATION HAS A DIFFERENT RECONSTITUTED CONCENTRATION, CAUTION SHOULD BE USED WHEN CALCULATING THE VOLUME TO BE ADMINISTERED. The recommended starting dose of VELCADE is 1.3 mg/m 2 . VELCADE may be administered intravenously at a concentration of 1mg/mL, or subcutaneously at a concentration of 2.5 mg/mL (see reconstitution /preparation for intravenous and subcutaneous administration section 4.8). When administered intravenously, VELCADE is administered as a 3 to 5 second bolus intravenous injection. 4.1 DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA VELCADE is administered in combination with oral melphalan and oral prednisone for 9, six week treatment cycles as s Leer el documento completo