Country: নিউ জিলণ্ড
ভাষা: ইংরেজি
সূত্র: Medsafe (Medicines Safety Authority)
Bortezomib 3.5mg (as a mannitol boronic ester)
Dr Reddy's New Zealand Limited
3.5 mg
Powder for injection
Active: Bortezomib 3.5mg (as a mannitol boronic ester) Excipient: Mannitol
Prescription
Bortezomib - Dr. Reddy's, 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 - Dr. Reddy's 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 - Dr. Reddy's is also indicated 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, USP type l, 10 mL, bromobutyl rubber stopper and aluminium flip-off seal in outer cardboard carton - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)
2014-06-13
1 NEW ZEALAND DATASHEET 1 PRODUCT NAME BORTEZOMIB – Dr. Reddy’s 3.5 mg powder for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Bortezomib 3.5.mg as a mannitol boronic ester. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Each single dose vial contains 3.5mg of bortezomib as a sterile lyophilised powder for injection. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications BORTEZOMIB – Dr. Reddy’s 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 - Dr. Reddy’s, 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 - Dr. Reddy’s 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 Dose and method of administration RECOMMENDED DOSAGE BORTEZOMIB - Dr. Reddy’s is for intravenous or subcutaneous use only. Intrathecal administration has resulted in death. BORTEZOMIB - Dr. Reddy’s 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). BECAUSE EACH ROUTE OF ADMINISTRATION HAS A DIFFERENT RECONSTITUTED CONCENTRATION, CAUTION SHOULD BE USED WHEN CALCULATING THE VOLUME TO BE ADMINISTERED. BORTEZOMIB - Dr. Reddy’s retreatment may be considered for multiple myeloma patients who had previously responded to treatment with bortezomib (see section 5.1 - Clinical Trials). PREVIOUSLY UNTREATED MULTIPLE MYELOMA _TRANSPLANT ELIGIBLE _ _ _ 1. BORTEZOMIB - DR. REDDY’S PLUS THALIDOMIDE-DEXAMETHASONE During the induction stage, BORTEZOMIB - Dr. Reddy’s is administered twice weekly in combination with thalidomide-dexamethasone for three 3-week treatment cycles. Following stem cell transplanta সম্পূর্ণ নথি পড়ুন