Imuran

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Azathioprine 50mg (as freeze-dried sodium salt);  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Azathioprine 50 mg (as freeze-dried sodium salt)

Dosage:

50 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Azathioprine 50mg (as freeze-dried sodium salt)   Excipient: Sodium hydroxide

Units in package:

Vial, glass, 1 dose unit

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: Vial, glass, - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1969-12-31

Patient Information leaflet

IMURAN Injection NZ - CMI  

Page 1 of 4

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, bowel 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. 
�

Summary of Product characteristics

IMURAN 50 mg Injection
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
IMURAN
IMURAN INJECTION (AZATHIOPRINE 50 MG)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of the active ingredient azathioprine as the
sodium salt.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
IMURAN Injection is supplied as a yellow to amber freeze-dried powder
for solution for
injection/infusion in a neutral glass vial with a rubber closure and
aluminium collar.
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 refracto