Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
BORTEZOMIB
ABIC MARKETING LTD, ISRAEL
L01XX32
POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB 3.5 MG
I.V, S.C
Required
S.C SINDAN-PHARMA S.R.L
BORTEZOMIB
Bortezo Teva is indicated for the treatment of patients with multiple myeloma. Bortezo Teva is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezo 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.
2018-12-05
Page 1 of 63 Bortez-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-10-2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT BORTEZ TEVA 3.5MG 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 6. Powder for Solution for Injection. 3. THERAPUETIC INDICATIONS 3.1 MULTIPLE MYELOMA Bortez Teva 3.5mg is indicated for the treatment of patients with multiple myeloma. 3.2 MANTLE CELL LYMPHOMA Bortez Teva 3.5mg is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortez Teva 3.5mg 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 Bortez Teva 3.5 mg is for intravenous or subcutaneous use only. Bortez 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 Bortez Teva 3.5 mg (bortezomib) is 1.3mg/m 2 . Bortez Page 2 of 63 Bortez-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-10-2021 Teva 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, Bortez Teva 3.5 mg is administered as a 3 to 5 second bolus intravenous injection. 4.1 DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA Bortez Teva 3 Διαβάστε το πλήρες έγγραφο