REVLIMID (Lenalidomide) Capsules 25mg

국가: 말레이시아

언어: 영어

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

유효 성분:

lenalidomide.

제공처:

Celgene Sdn. Bhd.

INN (International Name):

lenalidomide.

패키지 단위:

21Capsule Capsules

Manufactured by:

Celgene International Sarl

환자 정보 전단

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
REVLIMID
_®_ CAPSULE
_ _
Lenalidomide (5mg, 10mg, 15mg, 25mg)
__________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What Revlimid
®
is used for
2.
How Revlimid
®
works
3.
Before you use Revlimid
®
4.
How to use Revlimid
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Revlimid
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT REVLIMID
® IS USED FOR
_What is Revlimid_
_®_
_ _
Revlimid
®
contains the active substance
‘lenalidomide’. This medicine belongs to
a group of medicines which affect how
your immune system works.
_What Revlimid_
_®_
_ is used for _
Revlimid
®
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
Revlimid
®
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
Revlimid
®
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 Revlimid
®
on its own.
Multiple myeloma – in patients who have
had treatment before
Revlimid
®
is taken together with an anti-
inflammatory medicine called
‘dexamethasone’.
HOW REVLIMID
® WORKS
Revlimid
®
works by affecting the body’s
immune system and directly attacking the
cancer. It works in a number of differen

제품 특성 요약

1
1.
NAME OF THE MEDICINAL PRODUCT
Revlimid
®
5 mg hard capsules
Revlimid
®
10 mg hard capsules
Revlimid
®
15 mg hard capsules
Revlimid
®
25 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each Revlimid
®
5 mg hard capsule contains 5 mg of lenalidomide.
Excipient: Each capsule contains 147 mg of anhydrous lactose.
Each Revlimid
®
10 mg hard capsule contains 10 mg of lenalidomide.
Excipient: Each capsule contains 294 mg of anhydrous lactose.
Each Revlimid
®
15 mg hard capsule contains 15 mg of lenalidomide.
Excipient: Each capsule contains 289 mg of anhydrous lactose.
Each Revlimid
®
25 mg hard capsule contains 25 mg of lenalidomide.
Excipient: Each capsule contains 200 mg of anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Revlimid
®
5 mg hard capsules: White to off-white, opaque size 2 hard gelatin
capsule with a black imprint
“REV 5mg”, contains white to off-white to pale-yellow powder.
Revlimid
®
10 mg hard capsules: Pale yellow opaque body, blue green opaque cap,
size 0, hard gelatin
capsules with a black imprint “REV 10mg”, contains white to
off-white to pale-yellow powder.
Revlimid
®
15 mg hard capsules: White to off-white opaque body, powder blue
opaque cap, size 0, hard
gelatin capsule with a black imprint “REV 15mg”, contains white to
off-white to pale-yellow powder.
Revlimid
®
25 mg hard capsules: White to off-white, opaque size 0 hard gelatin
capsule with a black imprint
“REV 25mg”, contains white to off-white to pale-yellow powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Revlimid
®
as monotherapy is indicated for the maintenance treatment of adult
patients with newly diagnosed
multiple myeloma who have undergone autologous stem cell
transplantation.
Revlimid
®
in combination with dexamethasone is indicated for the treatment of
previously untreated multiple
myeloma patients who are not eligible for transplant.
Revlimid
®
in combination with dexamethasone is indicated for the treatment of