Truxima 100mg10ml concentrate for solution for infusion 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:

Napp Pharmaceuticals Ltd

ATCコード:

L01XC02

INN（国際名）:

Rituximab

投薬量:

10mg/1ml

医薬品形態:

Solution for infusion

投与経路:

Intravenous

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: 08020300; GTIN: 8806238000629

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRUXIMA 100 MG CONCENTRATE FOR SOLUTION FOR INFUSION rituximab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Truxima is and what it is used for
2.
What you need to know before you use Truxima
3.
How to use Truxima
4.
Possible side effects
5.
How to store Truxima
6.
Contents of the pack and other information
1.
WHAT TRUXIMA IS AND WHAT IT IS USED FOR
WHAT TRUXIMA IS
Truxima contains the active substance “rituximab”. This is a type
of protein called a “monoclonal
antibody”. It is designed to stick to a type of white blood cell
called “B-Lymphocyte”. When
sticking to the surface of this cell, rituximab causes the cell to
die.
WHAT TRUXIMA IS USED FOR
Truxima may be used for the treatment of several different conditions
in adults. Your doctor may
prescribe Truxima for the treatment of:
A)
NON-HODGKIN’S LYMPHOMA
This is a disease of the lymph tissue (part of the immune system) that
affects B-Lymphocytes.
Truxima can be given alone or with other medicines called
“chemotherapy”.
If the treatment is working, Truxima may be continued 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 B-
lymphocytes, which originate in the bone marrow and develop in the
lymph nodes. Patients with
CLL have too many abnormal lymphocytes, which ac

製品の特徴

OBJECT 1
TRUXIMA 100 MG CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 27-Feb-2018 | Napp
Pharmaceuticals Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Truxima 100 mg concentrate for solution for infusion
2. Qualitative and quantitative composition
Each vial contains 100 mg of rituximab.
Each mL of concentrate contains 10 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.
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
Truxima is indicated in adults for the following indications:
Non-Hodgkin's lymphoma (NHL)
Truxima is indicated for the treatment of previously untreated
patients with stage III-IV follicular
lymphoma in combination with chemotherapy.
Truxima maintenance therapy is indicated for the treatment of
follicular lymphoma patients responding to
induction therapy.
Truxima monotherapy is indicated for treatment of patients with stage
III-IV follicular lymphoma who
are chemo-resistant or are in their second or subsequent relapse after
chemotherapy.
Truxima 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)
Truxima in co