VELCADE 3.5mg FOR INJECTION

Country: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

BORTEZOMIB

থেকে পাওয়া:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

এটিসি কোড:

L01XX32

ডোজ:

3.5mg

ফার্মাসিউটিকাল ফর্ম:

INJECTION, POWDER, FOR SOLUTION

রচনা:

BORTEZOMIB 3.5mg

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

BSP Pharmaceuticals S.p.A. (BSP)

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2005-03-15

তথ্য লিফলেট

 
1 

NAME OF THE MEDICINAL PRODUCT 
VELCADE

 (bortezomib) for Injection 
VELCADE is a registered trademark of Millennium Pharmaceuticals,
Inc. 

QUALITATIVE AND QUANTITATIVE COMPOSITION  
VELCADE
®
 (bortezomib) for Injection is an antineoplastic agent available
for intravenous injection (IV) 
or subcutaneous (SC) use. Each single use vial contains: 
  3.5 mg of bortezomib as a sterile lyophilized powder.
 Inactive ingredient: 35 mg mannitol, USP 
and nitrogen gs 
(IV or SC use)

PHARMACEUTICAL FORM  
VELCADE
®
 (bortezomib) for Injection is supplied as individually
cartoned 10 mL single use vials 
containing 3.5 mg of bortezomib as a white to off-white cake or
powder. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
VELCADE (bortezomib) for Injection is indicated as part of
combination therapy for the treatment of 
patients with previously untreated multiple myeloma. 
VELCADE (bortezomib) for Injection is
indicated as monotherapy for the treatment of patients with 
multiple myeloma who have received at least 1 prior therapy.  
VELCADE (bortezomib) for Injection is indicated for the
treatment of patients with mantle cell 
lymphoma who have received at least 1 prior therapy. 

POSOLOGY AND METHOD OF ADMINISTRATION 

VELCADE 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
VELCADE._ _

VELCADE IS FOR INTRAVENOUS OR SUBCUTANEOUS

USE ONLY.  INTRATHECAL 
ADMINISTRATION HAS RESULTED IN DEATH. 

MONOTHERAPY 
_Recommended Dosage _
The recommended dose of VELCADE is 1.3 mg/m
2
/dose administered twice weekly for 2 weeks (Days 1, 
4, 8, and 11) followed by a 1

পণ্য বৈশিষ্ট্য

1
PRODUCT NAME
VELCADE

(bortezomib) for Injection
VELCADE

3.5 mg Powder for Solution and for Injection
VELCADE

_ is a registered trademark of Millennium Pharmaceuticals, Inc. _
DOSAGE FORMS AND STRENGTHS
VELCADE

(bortezomib) for Injection is supplied as individually cartoned 10 mL
single use
vials containing 3.5 mg of bortezomib as a white to off-white cake or
powder.
•
3.5 mg single use vial
VELCADE

(bortezomib) for Injection is an antineoplastic agent available for
intravenous
injection (IV) or subcutaneous (SC) use. Each single use vial
contains:
•
3.5 mg of bortezomib as a sterile lyophilized powder. Inactive
ingredient: 35 mg
mannitol, USP/EP (IV or SC use).
CLINICAL INFORMATION
INDICATIONS
VELCADE

(bortezomib) for Injection is indicated as part of combination therapy
for the
treatment of patients with previously untreated multiple myeloma.
VELCADE

(bortezomib) for Injection is indicated as monotherapy for the
treatment of patients
with multiple myeloma who have received at least 1 prior therapy.
VELCADE

(bortezomib) for Injection is indicated as monotherapy for the
treatment of patients
with mantle cell lymphoma who have received at least 1 prior therapy.
VELCADE

(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
VELCADE

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 VELCADE

.
_ _
VELCADE

IS FOR INTRAVENOUS
OR SUBCUTANEOUS
USE ONLY
. INTRATHECAL
ADMINISTRATION HAS RESULTED IN DEATH.
2
MONOTHERAPY
_R