Bortezomib Juno

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Bortezomib 1mg (as mannitol boronic ester)

Beschikbaar vanaf:

Juno Pharmaceuticals NZ Limited

Dosering:

1 mg

farmaceutische vorm:

Powder for injection

Samenstelling:

Active: Bortezomib 1mg (as mannitol boronic ester) Excipient: Mannitol

Prescription-type:

Prescription

therapeutische indicaties:

- 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.

Product samenvatting:

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

Autorisatie datum:

2019-04-12

Productkenmerken

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