Երկիր: Իսրայել
Լեզու: անգլերեն
Աղբյուրը: Ministry of Health
BORTEZOMIB AS MANNITOL BORONIC ESTER
K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL
L01XX32
POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB AS MANNITOL BORONIC ESTER 3.5 MG
S.C, I.V
Required
PHARMAIDEA, LATVIA
BORTEZOMIB
Multiple MyelomaBORTEZOMIB S.K is indicated for the treatment of patients with multiple myeloma.Mantle Cell LymphomaBORTEZOMIB S.K is indicated for the treatment of patients with mantle cell Lymphoma who have received at least one prior therapy.BORTEZOMIB S.K 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.
2021-10-31
Page 1 of 40 FULL PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT BORTEZOMIB S.K. 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 BORTEZOMIB S.K . is indicated for the treatment of patients with multiple myeloma 3.2 MANTLE CELL LYMPHOMA BORTEZOMIB S.K . (bortezomib) for Injection is indicated for the treatment of patients with mantle cell Lymphoma who have received at least one prior therapy BORTEZOMIB S.K 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 BORTEZOMIB S.K IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. BORTEZOMIB S.K 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 S.K is 1.3mg/m 2 . BORTEZOMIB S.K 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, BORTEZOMIB S.K is administered as a 3 to 5 second bolus intravenous injection. 4.1 DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA BORTEZOMIB S.K is administered in combination with oral melphalan and oral prednisone for 9, six week treatment cycles as shown in _Table 1_. In Cycles 1 to 4, BORTEZO Կարդացեք ամբողջական փաստաթուղթը