MABTHERA CONCENTRATE FOR SOLUTION FOR INFUSION 500 mg50ml

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

RITUXIMAB

متاح من:

ROCHE SINGAPORE PTE. LTD.

ATC رمز:

L01XC02

جرعة:

10 mg/ml

الشكل الصيدلاني:

INJECTION

تركيب:

RITUXIMAB 10 mg/ml

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

Roche Diagnostics GmbH

الوضع إذن:

ACTIVE

تاريخ الترخيص:

1998-08-22

نشرة المعلومات

 
1
MABTHERA
®

Rituximab

CONCENTRATE FOR SOLUTION FOR INFUSION 
1. P
HARMACEUTICAL 
F
ORM

Vial 100 mg/10 ml and 500 mg/50 ml. 
The content of the vial is a clear to opalescent
liquid, colorless to pale yellow. 

2. Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

Active ingredient: rituximab. 

3. C
LINICAL 
P
ARTICULARS

3.1 THERAPEUTIC INDICATIONS 
MabThera
is indicated for the treatment of patients with relapsed or chemoresistant indolent 
B-cell non-Hodgkin’s lymphomas. 
MabThera is indicated for
the treatment of patients with CD20 positive diffuse large
B-cell 
non-Hodgkin’s lymphoma (DLCL) in combination with CHOP
(cyclophosphamide, 
doxorubicin vincristine and prednisone) chemotherapy. 
MabThera is indicated for the treatment
of previously untreated patients with stage III-IV 
follicular lymphoma in combination with CVP chemotherapy. 
MabThera maintenance therapy is indicated for the treatment
of follicular lymphoma 
patients responding to induction therapy. 
_ _
_Chronic Lymphocytic Leukaemia _
MabThera is indicated in combination with fludarabine and
cyclophosphamide (FC), for the 
treatment of patients with previously untreated
and previously treated CD20-positive CLL. 

_Rheumatoid Arthritis _
MabThera in combination with methotrexate is indicated for the
treatment of adult patients 
with severe active
rheumatoid arthritis who have had an inadequate response
or intolerance 
to one or more tumour necrosis factor (TNF)
inhibitor therapies. 

3.2  DOSAGE AND METHOD OF ADMINISTRATION 
3.2.1 STANDARD DOSAGE 
MabThera should be administered as an i.v. infusion through
a dedicated line, in an 
environment where full resuscitation facilities are
immediately available, and under the 
close supervision of an experienced physician
_ _
The prepared infusion solution must not be admin

خصائص المنتج

1
Please visit www.roche.com.sg/pharma/mabthera for a printable version
of this leaflet.
INF/INJ-MAB-2022 08-0
MabThera
®
Rituximab
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Antineoplastic agent.
ATC Code: L01FA01
1.2
TYPE OF DOSAGE FORM
Intravenous (IV) formulation: concentrate for solution for infusion
Subcutaneous (SC) formulation: solution for subcutaneous injection
1.3
ROUTE OF ADMINISTRATION
Intravenous formulation: intravenous infusion
Subcutaneous formulation: subcutaneous injection
1.4
STERILE/RADIOACTIVE STATEMENT
Sterile product.
The content of the vial is a clear to opalescent liquid, colorless to
pale yellow.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
rituximab.
_INTRAVENOUS FORMULATION _
MabThera IV is a clear, colourless liquid supplied in sterile,
preservative-free, non-pyrogenic single-dose vials.
Excipients: Sodium citrate, Polysorbate 80, Sodium chloride, Water for
injection
Single-dose vials contain 100 mg/10 ml and 500 mg/50 ml.
_SUBCUTANEOUS FORMULATION _
MabThera SC is a clear to opalescent, colourless to yellowish liquid
supplied in sterile, preservative-free, non-pyrogenic, single use
vials.
MabThera SC contains recombinant human hyaluronidase (rHuPH20), an
enzyme used to increase the dispersion and absorption of
co-administered
substances when administered subcutaneously
_._
Excipients:
Recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine
hydrochloride monohydrate,

,

-trehalose dihydrate, L-methionine,
Polysorbate 80, Water for injection
_Subcutaneous formulation for non-Hodgkin’s lymphoma: _
Single dose vials contain 1400 mg/11.7 mL rituximab.
2.
CLINICAL
PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
_MABTHERA IV AND MABTHERA SC _
NON-HODGKIN’S LYMPHOMA:
MabThera IV and MabThera SC are indicated for the treatment of:

patients with CD20 positive diffuse large B-cell non-Hodgkin’s
lymphoma (DLCL) in combination with CHOP (cyclophosphamide,
doxorubicin, vincristine and prednisone) chemotherapy.

previously untreated pat