Imuran 50mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AZATHIOPRINE

Boleh didapati daripada:

Aspen Medical Products Malaysia Sdn Bhd

INN (Nama Antarabangsa):

AZATHIOPRINE

Unit dalam pakej:

100 Tablets

Dikeluarkan oleh:

Aspen SA Operations (Pty) Ltd

Risalah maklumat

_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
11. Serial Number
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

Ciri produk

IMURAN
AZATHIOPRINE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of the active ingredient azathioprine.
PHARMACEUTICAL FORM
Azathioprine Tablets 50mg are yellow, round, biconvex, film-coated
tablets which are
scored, branded IM 5 and contains 50mg Azathioprine Ph. Eur. in each
tablet.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Azathioprine
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.
Azathioprine, in combination with corticosteroids 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 transplant recipients.
Azathioprine, 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 of
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 refractory idiopathic thrombocytopenic purpura
POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL
Azathioprine_ _tablets should be administered at least 1 hour before
or 3 hours after food or
milk (_see Pharmacokinetic Properties_).
POSOLOGY POPULATIONS
•
ADULTS
TRANSPLANTS
Depending on the immunosuppressive regimen employed, a dosage of up to
5 mg/kg
bodyweight/day may be given orally on the first day of therapy.
Maintenance dosage should range from 1 to 4 mg/kg bodyweight/day and