Imuran 50mg powder for injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

azathioprine, Quantity: 50 mg

Tilgjengelig fra:

Aspen Pharmacare Australia Pty Ltd

Legemiddelform:

Injection, powder for

Sammensetning:

Excipient Ingredients: sodium hydroxide

Administreringsrute:

Intravenous

Enheter i pakken:

1 vial X 50mg

Klasse:

Medicine Registered

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

INDICATIONS AS AT 11 FEBRUARY 2005: 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 form the following: severe rheumatoid arthritis; systemic lupus erythematosus; dermatomyositis/polymyositis; autoimmune chronic active hepatitis; pemphigus vulgaris; polya

Produkt oppsummering:

Visual Identification: A yellow to amber freeze dried powder.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Registered

Autorisasjon dato:

1991-08-02

Informasjon til brukeren

IMURAN
® INJECTION
_azathioprine_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IMURAN Injection.
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 giving you IMURAN
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IMURAN
INJECTION IS USED FOR
IMURAN Injection contains
azathioprine as the active ingredient.
Azathioprine belongs to a group of
medicines called
immunosuppressants.
IMURAN Injection 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 Injection 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 Injection is usually given
in combination with other medicines
such as corticosteroids or other
immunosuppressive drugs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IMURAN
INJECTION 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 ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN IMURAN
INJECTION IF YOU HAVE EVER HAD AN
ALLERGIC REACTION TO:
•
azathioprine
•
6-mercaptopurine (Puri-Nethol), a
medicine which is similar to
IMURAN Injection
•
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;
swelli

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