Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
BORTEZOMIB
TEVA ISRAEL LTD
L01XX32
POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB 3.5 MG
S.C, I.V
Required
TEVA ISRAEL LTD, ISRAEL
BORTEZOMIB
Bortezomib Teva is indicated for the treatment of patients with multiple myeloma. Bortezomib Teva is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib Teva 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
2022-06-30
Page 1 of 63 Bortezomib-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-01-2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BORTEZOMIB TEVA 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 6. Powder for Solution for Injection I.V., S.C. 3. THERAPUETIC INDICATIONS 3.1 Multiple Myeloma Bortezomib Teva 3.5 mg is indicated for the treatment of patients with multiple myeloma. 3.2 Mantle Cell Lymphoma Bortezomib Teva 3.5 mg is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib Teva 3.5 mg 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 Teva 3.5 mg is for intravenous or subcutaneous use only. Bortezomib Teva 3.5 mg 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 Teva 3.5 mg (bortezomib) is 1.3mg/m 2 . Page 2 of 63 Bortezomib-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-01-2023 Bortezomib Teva 3.5 mg 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 Teva 3.5 mg is administered as a 3 to 5 second bolus intravenous injection. 4.1 Dosage in P Izlasiet visu dokumentu