MabThera 1400mg11.7ml solution for injection vials

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Rituximab

から入手可能:

Roche Products Ltd

ATCコード:

L01XC02

INN（国際名）:

Rituximab

投薬量:

119.66mg/1ml

医薬品形態:

Solution for injection

投与経路:

Subcutaneous

クラス:

No Controlled Drug Status

処方タイプ:

VMP not recommended to prescribe - brands not bioequivalent

製品概要:

BNF:

情報リーフレット

1
uk-ie-mt-pil-mabthera-clean-180316-1400-sc
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MABTHERA 1400 MG SOLUTION FOR SUBCUTANEOUS INJECTION
rituximab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 are given MabThera
3.
How MabThera is given
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.
MabThera is available as a medicine given as a drip (called MabThera
100 mg or MabThera 500 mg,
concentrate for solution for infusion) and as a medicine for injection
under your skin (called
MabThera 1400 mg or MabThera 1600 mg, solution for subcutaneous
injection).
WHAT MABTHERA IS USED FOR
MabThera 1400 mg is used to treat Non-Hodgkin’s lymphoma in adults.
•
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 1400 mg can be given alone or with other medicines called
“chemotherapy”.
You will always be given MabThera as a drip (intra-venous infusion) at
the start of your treatment.
After this, you will be given MabThera as an injection under your
skin. Your doctor will decide when
to start MabThera injections.
In patients where the treatment is working, MabThera may be used as a
maintenance treatment for 2
ye

製品の特徴

OBJECT 1
MABTHERA 1400 MG SOLUTION FOR SUBCUTANEOUS
INJECTION
Summary of Product Characteristics Updated 30-May-2018 | Roche
Products Limited
1. Name of the medicinal product
MabThera 1400 mg solution for subcutaneous injection
2. Qualitative and quantitative composition
Each mL contains 120 mg of rituximab.
Each vial containS 1400 mg/11.7 mL 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 less than 1mmol sodium per dose, i.e.
essentially sodium free.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear to opalescent, colourless to yellowish liquid.
4. Clinical particulars
4.1 Therapeutic indications
MabThera is indicated in adults for 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 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.
4.2 Posology and method of administration
MabThera should be administered under the close supervision of an
experienced healthcare professional,
and in an environment where full resuscitation facilities are
immediately available (see section 4.4).
Premedication consisting of an anti-pyretic and an antihistaminic,
e.g. paracetamol and diphenhydramine,
should always be given before each