MIBZO POWDER FOR SOLUTION FOR INJECTION 3.5MGVIAL

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

Bortezomib

Dostupno od:

GOLDPLUS UNIVERSAL PTE LTD

ATC koda:

L01XX32

Farmaceutski oblik:

INJECTION, POWDER, FOR SOLUTION

Sastav:

Bortezomib 3.500mg/vial

Administracija rute:

INTRAVENOUS, SUBCUTANEOUS

Tip recepta:

Prescription Only

Proizveden od:

MSN Laboratories Private Limited

Status autorizacije:

ACTIVE

Datum autorizacije:

2023-10-25

Svojstava lijeka

Black
Version No.: 09
Front Page
Font size: 6pt
NOTE: Artwork dimensions shall be finalized during commercialization
of the product.
Bortezomib Powder for Solution for Injection 3.5mg/vial
MIBZO
Label claim:
Each vial contains Bortezomib 3.5 mg
After reconstitution, 1 ml of solution for subcutaneous injection
contains 2.5 mg bortezomib. After reconstitution, 1 ml of solution for
intravenous
injection contains 1 mg bortezomib.
For the full list of excipients, in section Pharmaceutical
Particulars.
PHARMACEUTICAL FORM
Powder for solution for injection. 1 vial
White to off-white Lyophilized cake or powder.
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS
Bortezomib
for Injection is indicated as part of combination therapy for the
treatment of patients with previously untreated multiple myeloma.
Bortezomib
for Injection is indicated as monotherapy for the treatment of
patients with multiple myeloma who have received at least 1 prior
therapy.
Bortezomib
for Injection is indicated as monotherapy for the treatment of
patients with mantle cell lymphoma who have received at least 1 prior
therapy.
Bortezomib
for Injection in combination with rituximab, cyclophosphamide,
doxorubicin and prednisone is indicated for the treatment of adult
patients with previously untreated mantle cell lymphoma who are
unsuitable for haematopoietic stem cell transplantation.
DOSAGE AND ADMINISTRATION
Bortezomib
may be administered:
•
Intravenously (at a concentration of 1 mg/ml) as a 3 to 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.
At least 72 hours should elapse between consecutive doses of
Bortezomib.
BORTEZOMIB
IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. INTRATHECAL
ADMINISTRATION HAS RESULTED IN DEATH.
MONOTHERAPY
_RELAPSED MULTIPLE MYELOMA AND RELAPSED MANTLE CELL LYMPHOMA_
RECOMMENDED DOSAGE
The recommended dose of Bortezomib
is 1.3 mg/m
2
/dose admini