Mabthera Sol for Inf 100 mg/10ml

País: Jordania

Idioma: inglés

Fuente: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Ingredientes activos:

Rituximab 100 mg/10ml

Disponible desde:

مستودع ادوية شاوي و رشيدات و مسنات - Shawi & Rushedat Drug Store

Código ATC:

L01XC02

Designación común internacional (DCI):

Rituximab 100 mg/10ml

Dosis:

100 mg/10ml

Unidades en paquete:

2 vials

Fabricado por:

Roche Diagnostics GmbH , Mannheim (المانيا)

Información para el usuario

Aug 2021
Product Information GCC
Ro 45-2294
MabThera
Aug 2021
1
Product Information GCC
MABTHERA
®
Rituximab
COMPOSITION
_Active substances:_
Rituximab (produced by recombinant DNA technology using CHO [Chinese
hamster ovary] cells).
_Excipients:_
Polysorbate 80 (produced from genetically modified maize), sodium
chloride, sodium citrate,
sodium hydroxide, hydrochloric acid, water for injection.
Each 10 ml vial of concentrate contains 52.6 mg of sodium; each 50 ml
vial of concentrate contains
263 mg of sodium.
PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE QUANTITY PER UNIT
1 rubber-stoppered vial with 10 ml concentrate for solution for
infusion contains 100 mg rituximab.
1 rubber-stoppered vial with 50 ml concentrate for solution for
infusion contains 500 mg rituximab.
INDICATIONS/USES
NON-
HODGKIN’S LYMPHOMA (NHL)
Monotherapy in patients with CD20-positive follicular non-Hodgkin’s
lymphoma (stage III–IV)
who have relapsed after, or failed to respond to, chemotherapy.
Treatment
of
previously
untreated
patients
with
CD20-positive
follicular
non-Hodgkin’s
lymphoma
(stage
III–IV)
with
high
tumour
burden
in
combination
with
CVP
or
CHOP.
Responders may be administered maintenance therapy with rituximab
monotherapy for 2 years.
Maintenance therapy of patients with relapsed or refractory
CD20-positive follicular non-
Hodgkin’s lymphoma (stage III–IV) who have responded to induction
therapy with CHOP with or
without rituximab.
Treatment of patients with CD20-positive diffuse large B-cell
non-Hodgkin’s lymphoma (DLBCL)
in combination with standard CHOP (8 cycles of cyclophosphamide,
doxorubicin, vincristine and
prednisone).
Use in combination with fludarabine and cyclophosphamide (R-FC) for
patients requiring
treatment for chronic lymphocytic leukaemia (CLL). Patients previously
treated with fludarabine
should have responded for a period of at least 6 months.
RHEUMATOID ARTHRITIS (RA)
MabThera in combination with methotrexate (MTX) is indicated for the
treatment of adult patients
with moderately severe to sever