Country: Ísrael
Tungumál: enska
Heimild: Ministry of Health
BORTEZOMIB
NEOPHARM (ISRAEL) 1996 LTD
L01XX32
POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB 3.5 MG/VIAL
I.V, S.C
Required
FRESENIUS KABI ONCOLOGY LIMITED, INDIA
BORTEZOMIB
Multiple MyelomaBortezomib Fresenius Kabi is indicated for the treatment of adult patients with multiple myeloma.Mantle Cell LymphomaBortezomib Fresenius Kabi for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib Fresenius Kabi 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.
2022-06-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BORTEZOMIB FRESENIUS KABI 3.5 MG 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 13. 3 PHARMACEUTICAL FORM Powder for solution for injection - I.V., S.C. 4 THERAPUETIC INDICATIONS 4.1 MULTIPLE MYELOMA BORTEZOMIB FRESENIUS KABI is indicated for the treatment of adult patients with multiple myeloma. 4.2 MANTLE CELL LYMPHOMA BORTEZOMIB FRESENIUS KABI (bortezomib) for Injection is indicated for the treatment of patients with mantle cell Lymphoma who have received at least one prior therapy. BORTEZOMIB FRESENIUS KABI 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. 5 DOSAGE AND ADMINISTRATION GENERAL DOSING GUIDELINES BORTEZOMIB FRESENIUS KABI IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. BORTEZOMIB FRESENIUS KABI must not be administered by any other route. 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 BORTEZOMIB FRESENIUS KABI is 1.3mg/m 2 . BORTEZOMIB FRESENIUS KABI 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 .9 5 ). When administered intravenously, BORTEZOMIB FRESENIUS KABI is administered as a 3 to 5 second bolus intravenous injection. 5.1 DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA BORTEZOMIB FRESENIUS KABI is administered in Lestu allt skjalið