Imuran

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Azathioprine 50mg;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Azathioprine 50 mg

Dosage:

50 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Azathioprine 50mg   Excipient: Hypromellose Lactose monohydrate Macrogol 400 Magnesium stearate Opaspray orange M-1-23104 Purified water Starch Stearic acid

Units in package:

Blister pack, Clear or white opaque PVC/AL, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Fermion Oy

Therapeutic indications:

Imuran is used as an immunosuppressant antimetabolities, 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 procedured, is indicated to enhance the survival of organ transplants, such as renal transplants, cardiac transplants, and hepatic transplants; and to reduce the corticosteroid requirements of renal transplant recipients. Imuran is indicated in the treatment of moderate to severe Crohn's disease in patients in whom corticosteroid therapy is required, in patients who cannot tolerate corticosteroid therapy, or in patients whose disease is refractory to other standard first line therapy. Imuran, either alone or more usually in combination with corticosteroids and/or other medicines 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 · permphigus vulgaris · polyarteritis nodosa · auto-immune haemolytic anaemia · chronic refractory idiopathic thrombocytopenic purpura · ulcerative colitis

Product summary:

Package - Contents - Shelf Life: Blister pack, Clear or white opaque PVC/AL - 100 tablets - 60 months from date of manufacture stored at or below 30°C protect from light

Authorization date:

1969-12-31

Patient Information leaflet

IMURAN
®
TABLETS
1
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 TA

Summary of Product characteristics

IMURAN 25mg, 50 mg Tablets
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
IMURAN 25MG, 50MG
Imuran tablets (azathioprine 25mg, 50mg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg, 50 mg azathioprine BP.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
25mg: Orange tablet, film coated, round, biconvex, unscored, branded
IM2.
50mg: Yellow tablet, film coated, round biconvex, scored, branded IM5.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
to
enhance the
survival
of
organ
transplants,
such
as renal
transplants, cardiac transplants, and hepatic transplants; and to
reduce the corticosteroid
requirements of renal transplant recipients.
IMURAN is indicated for the treatment of moderate to severe Crohn’s
disease in patients in
whom corticosteroid therapy is required, in patients who cannot
tolerate corticosteroid therapy,
or in patients whose disease is refractory to other standard first
line therapy.
IMURAN, either alone or more usually in combination with
corticosteroids and/or other
medicines 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;
•