Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Bortezomib 3mg (as a mannitol boronic ester)
Pfizer New Zealand Limited
3 mg
Powder for injection
Active: Bortezomib 3mg (as a mannitol boronic ester) Excipient: Mannitol
Prescription
Bortezomib 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 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 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, Clear type I with rubber stopper and aluminium seal in cardboard carton - 1 dose units - 36 months from date of manufacture stored at or below 25°C 8 hours reconstituted stored at or below 25°C
2018-01-08
Version: pfdborhv10323 Supersedes: pfdborhv11221 Page 1 of 40 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Hospira™ Bortezomib 1 mg, 2.5 mg, 3.0 mg, 3.5 mg powder for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose vial contains: • 1mg of bortezomib as a sterile lyophilised powder • 2.5 mg of bortezomib as a sterile lyophilised powder • 3.0 mg of bortezomib as a sterile lyophilised powder • 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. Hospira Bortezomib Powder for Injection is supplied as white, to off white lyophilised powder. The solubility of bortezomib, as the monomeric boronic acid, in water is: 3.3 – 3.8 mg/mL in a pH range of 2 – 6.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS_ _ Hospira Bortezomib powder for injection 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. Hospira Bortezomib powder for injection, 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 Hospira Bortezomib powder for injection 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 HOSPIRA BORTEZOMIB POWDER FOR INJECTION IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH. Hospira Bortezomib Powder for Injection may be administered: • Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus injection or Version: pfdborhv10323 Supersedes: pfdborhv11221 Page 2 of 40 • Subcutaneously (at a concentration of 2.5 mg/mL). Because each route of administration has a different reconstituted concentration, caution should Lestu allt skjalið