Alvogen Lenalidomide Capsule 25mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LENALIDOMIDE

Boleh didapati daripada:

LOTUS HEALTHCARE MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

LENALIDOMIDE

Unit dalam pakej:

21 Capsules

Dikeluarkan oleh:

Lotus Pharmaceutical Co., Ltd. Nantou Plant

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ALVOGEN LENALIDOMIDE CAPSULE
Lenalidomide (5mg, 25mg)
1
WHAT IS IN THIS LEAFLET
1.
What Alvogen
Lenalidomide is used for
2.
How Alvogen Lenalidomide
works
3.
Before you use Alvogen
Lenalidomide
4.
How to use Alvogen
Lenalidomide
5.
While you are using
Alvogen Lenalidomide
6.
Side effects
7.
Storage & disposal of
Alvogen Lenalidomide
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ALVOGEN LENALIDOMIDE IS
USED FOR
_What is Alvogen Lenalidomide _
Alvogen Lenalidomide contains
the active substance
‘lenalidomide’. This medicine
belongs to a group of medicines
which affect how your immune
system works.
_What Alvogen Lenalidomide is _
_used for _
Alvogen Lenalidomide is used in
adults for multiple myeloma.
_What is multiple myeloma _
Multiple myeloma is a type of
cancer which affects a certain
kind of white blood cell, called
the plasma cell. These cells
collect in the bone marrow and
divide, becoming out of control.
This can damage the bones and
kidneys.
Multiple myeloma generally
cannot be cured. However, the
signs and symptoms can be
greatly reduced or disappear for a
period of time. This is called a
‘response’.
Newly diagnosed multiple
myeloma – in patients who have
had a bone marrow transplant
Alvogen Lenalidomide is used on
its own as maintenance therapy
after patients have recovered
enough following a bone marrow
transplant.
Newly diagnosed multiple
myeloma – in patients who
cannot have a bone marrow
transplant
Alvogen Lenalidomide is taken
with an anti-inflammatory
medicine called
‘dexamethasone’. You will take
this other medicine at the start of
treatment and then continue to
take Alvogen Lenalidomide on
its own.
Multiple myeloma – in patients
who have had treatment before
Alvogen Lenalidomide is taken
together with an anti-
inflammatory medicine called
‘dexamethasone’.
HOW ALVOGEN LENALIDOMIDE
WORKS
Alvogen Lenalidomide works by
affecting the body’s immune
system and dir

Ciri produk

COPYRIGHTS / CONTACT
This artwork and its content is copyright of Alvogen
©Alvogen 2012. All rights reserved.
Any Anthropoidea digitally or hardcopy redistribution,
alternation or reproduction of part or all of the contents in
any form is prohibited by other than Alvogen staff for company
usage.
MAIN CONTACT:
David Garcia, Artwork Director
[e-mail]
MINIMUM FONT SIZE = 10PT
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CODES) PLEASE DO NOT APPROVE.
PRINT COLOURS
Black
Black 80%
SUPPORT COLOURS (NO PRINT)
Die Cut
REGULATORY APPROVAL
LENALIDOMIDE MALAYSIA 5MG
25MG X1 CAPS PIL
Die Cut size
Created
Modified
Proof round
ART Code
2 Pages - 520mm x 970mm
RM 15/05/2023
RM 20/06/2023
04
ARTDB025361P
Black 20%
Product Particulars
1.
NAME OF PRODUCT
Alvogen Lenalidomide Capsule 5mg
Alvogen Lenalidomide Capsule 25mg
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Each Alvogen Lenalidomide Capsule 5mg contains 5mg of lenalidomide.
Each Alvogen Lenalidomide Capsule 25mg contains 25mg of lenalidomide.
3.
DOSAGE FORM
Hard Capsules
4.
PRODUCT DESCRIPTION
Alvogen Lenalidomide Capsule 5mg :
A green opaque cap/ light brown opaque body, capsule shell size No. 2
imprinted in black ink with “LP” on the cap and “638”
on the body and filled with white powder
Alvogen Lenalidomide Capsule 25mg :
A white opaque cap/ white opaque body, capsule shell size No. 0
imprinted in black ink with “LP” on the cap and “642” on the
body and filled with white powder.
This product contains gelatine of bovine origin
5.1
PHARMACODYNAMICS
Pharmacotherapeutic group: Immunomodulating agent. ATC code: L04AX04.
The lenalidomide mechanism of action includes anti-neoplastic,
anti-angiogenic, pro-erythropoietic, and immunomodulatory
properties. Specifically, lenalidomide inhibits proliferation of
certain haematopoietic tumour cells (including MM plasma tumour
cells and those with deletions of chromosome 5), enhances T cell- and
Natural Killer (NK) cell-mediated immunity and increases
the number of NK T cel