Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Bortezomib 3.5mg (as mannitol boronic ester)
Juno Pharmaceuticals NZ Limited
3.5 mg
Powder for injection
Active: Bortezomib 3.5mg (as mannitol boronic ester) Excipient: Mannitol
Prescription
- In combination with melphalan and prednisone, indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. - As part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. - For the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.
Package - Contents - Shelf Life: Vial, glass, Type 1 with chlorobutyl stopper and Al flip-off cap in outer cardboard carton - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted (not refrigerated) stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2019-04-12
1 BORTEZOMIB JUNO BORTEZOMIB NEW ZEALAND DATA SHEET 1. PRODUCT NAME BORTEZOMIB JUNO 1 mg & 3.5 mg Powder for Injection 2. QUALITITATIVE AND QUANTITATIVE COMPOSITION BORTEZOMIB JUNO (bortezomib) is an antineoplastic agent for intravenous injection (IV) or subcutaneous (SC) use only. Each single dose vial contains: • 1 mg of bortezomib as a sterile lyophilised powder. or • 3.5 mg of bortezomib as a sterile lyophilised powder. For the full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM Powder for injection White to off-white cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BORTEZOMIB JUNO in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. BORTEZOMIB JUNO, as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma BORTEZOMIB JUNO is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. 4.2 DOSAGE AND ADMINISTRATION RECOMMENDED DOSAGE BORTEZOMIB JUNO IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH. BORTEZOMIB JUNO may be administered: • Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus injection or • Subcutaneously (at a concentration of 2.5 mg/mL). THE SUBCUTANEOUS ROUTE OF ADMINISTRATION IS APPLICABLE TO THE 3.5 MG PRESENTATION ONLY. BECAUSE EACH ROUTE OF ADMINISTRATION HAS A DIFFERENT RECONSTITUTED CONCENTRATION, CAUTION SHOULD BE USED WHEN CALCULATING THE VOLUME TO BE ADMINISTERED. 2 BORTEZOMIB JUNO retreatment may be considered for multiple myeloma patients who had previously responded to treatment with BORTEZOMIB JUNO (see CLINICAL TRIALS). PREVIOUSLY UNTREATED MULTIPLE MYELOMA _TRANSPLANT ELIGIBLE _ 1. BORTEZOMIB JUNO PLUS THALIDOMIDE-DEXAMET Прочитайте повний документ