Imuran 50mg Tablet

国家: 马来西亚

语言: 英文

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

现在购买

下载 资料单张 (PIL)
21-02-2020
下载 产品特点 (SPC)
12-07-2017

有效成分:

AZATHIOPRINE

可用日期:

Aspen Medical Products Malaysia Sdn Bhd

INN(国际名称):

AZATHIOPRINE

每包单位数:

100Tablet Tablets

厂商:

Excella GmbH & Co.KG

资料单张

                                _Consumer Medication Information Leaflet (RIMUP) _
1
IMURAN 50MG TABLET
Azathioprine (50mg)
WHAT IS IN THIS LEAFLET?
1.
What Imuran Tablet is used
for
2.
How Imuran Tablet works
3.
Before
you
use
Imuran
Tablet
4.
How to use Imuran Tablet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Imuran Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT IMURAN TABLET IS USED
FOR
Imuran Tablet is used to help
prevent
the
rejection
of
a
transplanted
organ
such
as
a
kidney, liver or heart.
Imuran Tablet can also be used
to
treat
other
diseases
called
autoimmune
diseases
where
your immune system is reacting
against your own body.
These may include:
•
severe rheumatoid arthritis
•
systemic
lupus
erythematosus
•
auto-immune chronic active
hepatitis
•
certain
auto-immune
skin,
muscle, and blood diseases.
Imuran Tablet is usually taken
in
combination
with
other
medicines
such
as
corticosteroids
or
other
immunosuppressive agents.
HOW IMURAN TABLET WORKS
Imuran
Tablet
contains
azathioprine
as
the
active
ingredient.
Azathioprine
belongs to a group of
medicines
called
immunosuppressant.
It
works
by
suppressing
the
body’s
immune defence system.
Ask your doctor if you have any
questions
about
why
this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE YOU USE IMURAN TABLET
-
_When you must not use it _
Do not take this medicine if you
have an allergy to:
•
azathioprine
•
6-mercaptopurine
Do not take Imuran Tablet if
you are pregnant, breastfeeding,
planning to become pregnant or
father a child unless you and
your doctor have discussed the
risks and benefits involved.
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows signs of tampering. If
it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should
start
taking
this
medicine, talk to your doctor.
-
_Before you start to use it _
Tell your doctor if yo
                                
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产品特点

                                IMURAN™
Azathioprine
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of the active ingredient azathioprine.
PHARMACEUTICAL FORM
I MURAN Tablets 50 mg are yellow, round, biconvex, film-coated tablets, scored, branded GX
CH1. Each tablet contains 50mg Azathioprine Ph. Eur.
CLINICAL PARTICULARS
IINDICATIONS
IMURAN is used as an immunosuppressant antimetabolite either alone or, more commonly,
in combination with other agents (usually corticosteroids) and procedures which influence the
immune response. Therapeutic effect may be evident only after weeks or months and can
include a steroid sparing effect, thereby reducing the toxicity associated with high dosage and
prolonged usage of corticosteroids.
IMURAN, in combination with corticost eroids and/or other immunosuppressive agents and
procedures, is indicated to enhance the survival of organ transplants, such as renal
transplants, cardiac transplants and hepatic transplants. It also reduces the corticosteroid
requirements of renal transpl ant recipients.
IMURAN, either alone or more usually in combination with corticosteroids and/or other drugs
and procedures, has been used with clinical benefit (which may include reduction of dosage
or discontinuation of corticosteroids) in a proportion o f patients suffering from the following:
severe rheumatoid arthritis
systemic lupus erythematosus
dermatomyositis and polymyositis
auto- immune chronic active hepatitis
pemphigus vulgaris
polyarteritis nodosa
auto- immune haemolytic anaemia
chronic refrac tory idiopathic thrombocytopenic purpura
DOSAGE AND ADMINISTRATION
METHOD OF ADMINISTRATION
IMURAN tablets should be administered at least 1 hour before or 3 hours after food or milk
( see Pharmacological Properties: Pharmacokinetics; Absorption ).
                                
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