BORTEZOMIB HETERO bortezomib 3.5 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bortezomib, Quantity: 3.5 mg

Available from:

Hetero Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol

Administration route:

Intravenous Bolus, Subcutaneous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BORTEZOMIB HETERO in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy. BORTEZOMIB HETERO 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 HETERO is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease. BORTEZOMIB HETERO in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Product summary:

Visual Identification: White to off-white cake or powder contained in a clear glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-08-05