Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
BORTEZOMIB
TARO INTERNATIONAL LTD, ISRAEL
L01XX32
POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB 3.5 MG/VIAL
I.V, S.C
Required
TARO INTERNATIONAL LTD, ISRAEL
BORTEZOMIB
Bortezomib is indicated for the treatment of patients with multiple myeloma.Bortezomib is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib 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.
2019-06-30
Page 1 of 48 FULL PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Bortezomib Taro 3.5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester). After reconstitution, each 1 mL of solution for subcutaneous injection contains 2.5 mg bortezomib. After reconstitution, each 1 mL of solution for intravenous injection contains 1 mg bortezomib. For the full list of excipients, see section 12. PHARMACEUTICAL FORM Powder for Solution for Injection 3. THERAPEUTIC INDICATIONS 3.2 MULTIPLE MYELOMA Bortezomib Taro 3.5 mg is indicated for the treatment of patients with multiple myeloma. 3.3 MANTLE CELL LYMPHOMA Bortezomib Taro 3.5 mg is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib Taro 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 TARO 3.5 MG IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. Bortezomib Taro 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 Taro 3.5 mg is 1.3 mg/m 2 . Bortezomib Taro 3.5 mg may be administered intravenously at a concentration of 1 mg/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 Taro 3.5 mg is administered as a 3 to 5 second bolus intravenous injection. Page 2 of 48 4.1 DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA Bortezomib Taro is administered in combination with oral melphalan and oral prednisone fo Soma hati kamili