Bortezomib - Dr. Reddy's

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Bortezomib 3.5mg (as a mannitol boronic ester)

Disponible desde:

Dr Reddy's New Zealand Limited

Dosis:

3.5 mg

formulario farmacéutico:

Powder for injection

Composición:

Active: Bortezomib 3.5mg (as a mannitol boronic ester) Excipient: Mannitol

tipo de receta:

Prescription

indicaciones terapéuticas:

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.

Resumen del producto:

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)

Fecha de autorización:

2014-06-13

Ficha técnica

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