IMURAN 25mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

azathioprine, Quantity: 25 mg

Tilgjengelig fra:

Aspen Pharmacare Australia Pty Ltd

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; maize starch; magnesium stearate; stearic acid; iron oxide yellow; iron oxide red; hypromellose; titanium dioxide; macrogol 400

Administreringsrute:

Oral

Enheter i pakken:

100 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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 system response. Therapeutic effect may be evident only after weeks or months & can include a steroid-sparing effect, thereby reducing the toxocity associated with high dosage and prolonged usage of corticosteroids. IMURAN, in combination with corticosteroids and/or other immunosuppressive agents and procedures, is indicated in the management of patients receiving organ transplants. IMURAN, either alone or more usually in combination with corticosteroids and/or other 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/polymyositis; autoimmune chronic active hepatitis; pemphigus vulgaris; polyarteritis nodosa; autoimmune hae

Produkt oppsummering:

Visual Identification: Orange, round, biconvex film-coated tablets, unscored and branded IM 2; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure and restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

1992-06-12

Informasjon til brukeren

IMURAN
® TABLETS
_azathioprine_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IMURAN. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking IMURAN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IMURAN IS USED
FOR
IMURAN contains azathioprine as
the active ingredient. Azathioprine
belongs to a group of medicines
called immunosuppressants.
IMURAN is used to help prevent the
rejection of a transplanted organ such
as a kidney, liver or heart. It works
by suppressing the body's immune
defence system.
IMURAN 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
•
chronic active hepatitis
•
certain skin, muscle, and blood
diseases.
IMURAN is usually taken in
combination with other medicines
such as corticosteroids or other
immunosuppressive drugs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IMURAN HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE IMURAN IF YOU HAVE
EVER HAD AN ALLERGIC REACTION TO:
•
azathioprine
•
6-mercaptopurine (Puri-Nethol), a
medicine which is similar to
IMURAN
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue or
any other parts of the body; rash,
itching or hives on the skin.
DO NOT TAKE IMURAN IF YOU ARE
P

Preparatomtale

IMURAN
®
_Product Information (PI)
Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION (PI)
IMURAN
®
(
Azathioprine
)TABLETS AND POWDER FOR INJECTION
1.
NAME OF THE MEDICINE
IMURAN tablets and powder for injection contain azathioprine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IMURAN is available in film-coated tablets and powder for injection.
IMURAN film-coated tablets contain either 25 mg or 50 mg of the active
azathioprine.
Excipients with known effect: sugars as lactose
IMURAN powder for injection contains 50 mg of the active azathioprine.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
25 mg: Orange, round, biconvex film-coated tablets, unscored and
branded IM 2
50 mg tablet: Yellow tablet, film-coated, round, biconvex, scored and
branded IM 5
50 mg powder for injection: A yellow to amber freeze dried powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
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 corticosteroids and/or other
immunosuppressive agents
and procedures, is indicated in the management of patients receiving
organ transplants.
IMURAN, either alone or more usually in combination with
corticosteroids and/or other
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/polymyositis;
autoimmune chronic active hepatitis;
pemphigus vulgaris;
polyarteritis nodosa;
autoimmune haemolytic anaemia;
IMURAN
®
_Product Information (PI) Page 2 of 16
chronic refractory idiopathic thrombocytopen