MabThera 100mg10ml concentrate for solution for infusion vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Rituximab

可用日期:

Roche Products Ltd

ATC代码:

L01XC02

INN（国际名称）:

Rituximab

剂量:

10mg/1ml

药物剂型:

Solution for infusion

给药途径:

Intravenous

类:

No Controlled Drug Status

处方类型:

VMP not recommended to prescribe - brands not bioequivalent

產品總結:

BNF: 08020300; GTIN: 5000471004977

资料单张

1
uk-ie-mt-pil-mabthera-clean-180316-100-inf
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MABTHERA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION
rituximab
READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What MabThera is and what it is used for
2.
What you need to know before you use MabThera
3.
How to use MabThera
4.
Possible side effects
5.
How to store MabThera
6.
Contents of the pack and other information
1.
WHAT MABTHERA IS AND WHAT IT IS USED FOR
WHAT MABTHERA IS
MabThera contains the active substance “rituximab”. This is a type
of protein called a “monoclonal
antibody”. It sticks to the surface of a type of white blood cell
called “B-Lymphocyte”. When
rituximab sticks to the surface of this cell, the cell dies.
WHAT MABTHERA IS USED FOR
MabThera may be used for the treatment of several different conditions
in adults. Your doctor may
prescribe MabThera for the treatment of:
A)
NON-HODGKIN’S LYMPHOMA
This is a disease of the lymph tissue (part of the immune system) that
affects a type of white blood cell
called B-Lymphocytes.
MabThera can be given alone or with other medicines called
“chemotherapy”.
In patients where the treatment is working, MabThera may be used as a
maintenance treatment for 2
years after completing the initial treatment.
B)
CHRONIC LYMPHOCYTIC LEUKAEMIA
Chronic lymphocytic leukaemia (CLL) is the most common form of adult
leukaemia. CLL affects a
particular lymphocyte, the B cell, which originates from the bone
marrow and develops in the lymph
nodes. Patients with CLL have too many abnormal lymphocytes, which
accumulate mainly in the bone
marrow and blood. The proliferation of these abnormal B-ly

产品特点

OBJECT 1
MABTHERA 100MG CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 30-May-2018 | Roche
Products Limited
1. Name of the medicinal product
MabThera 100 mg concentrate for solution for infusion
2. Qualitative and quantitative composition
Each mL contains 10 mg of rituximab.
Each vial contains 100 mg of rituximab.
Rituximab is a genetically engineered chimeric mouse/human monoclonal
antibody representing a
glycosylated immunoglobulin with human IgG1 constant regions and
murine light-chain and heavy-chain
variable region sequences. The antibody is produced by mammalian
(Chinese hamster ovary) cell
suspension culture and purified by affinity chromatography and ion
exchange, including specific viral
inactivation and removal procedures.
Excipients with known effects:
This medicinal product contains 2.3 mmol (52.6 mg ) sodium per 10mL
vial.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
Clear, colourless liquid.
4. Clinical particulars
4.1 Therapeutic indications
MabThera is indicated in adults for the following indications:
Non-Hodgkin's lymphoma (NHL)
MabThera is indicated for the treatment of previously untreated
patients with stage III-IV follicular
lymphoma in combination with chemotherapy.
MabThera maintenance therapy is indicated for the treatment of
follicular lymphoma patients responding
to induction therapy.
MabThera monotherapy is indicated for treatment of patients with stage
III-IV follicular lymphoma who
are chemoresistant or are in their second or subsequent relapse after
chemotherapy.
MabThera is indicated for the treatment of patients with CD20 positive
diffuse large B cell non-Hodgkin's
lymphoma in combination with CHOP (cyclophosphamide, doxorubicin,
vincristine, prednisolone)
chemotherapy.
Chronic lymphocytic leukaemia (CLL)
MabThera in combination with chemotherapy is indicated for the
treatment of patients with previously
untreated and relapsed/refractory CLL. Only limited data are available
on effi