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IMURAN INJECTION 50MG/VIAL

Active substance(s): AZATHIOPRINE / AZATHIOPRINE / AZATHIOPRINE

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may be expected to be within the range pH 8.0 to
9.5 (the greater the dilution, the lower the pH).
Information for the Physician

Imuran® Injection
azathioprine

Please refer to the Summary of Product

Where dilution is not practicable, the reconstituted

Package Leaflet: Information for the User

solution should be injected slowly over a period of

Imuran® Injection

not less than one minute and followed immediately
by not less than 50 ml of one of the recommended
infusion solutions.

Characteristics (SPC) for further details on

Care must be taken to avoid perivenous injection,

this product.

which may produce tissue damage.

Trade Name of the Medicinal Product

Reconstitution and dilution of Imuran Injection

Imuran Injection

Precautions should always be taken when handling
Imuran Injection (see Instructions for Use/Handling).

Qualitative and Quantitative Composition
Azathioprine EP 50 mg/vial
Pharmaceutical Form
Injection
Method of Administration
Imuran Injection should be used only when the oral
route is impractical, and should be discontinued
as soon as oral therapy is tolerated. It must be

No antimicrobial preservative is included. Therefore
reconstitution and dilution must be carried out under
full aseptic conditions, preferably immediately before
use. Any unused solution should be discarded.
The contents of each vial should be reconstituted by
the addition of 5 ml to 15 ml of Water for Injections.
The reconstituted solution is stable for up to 5 days
when stored between 5°C and 25°C.
When diluted on the basis of 5 ml of reconstituted

administered only by the intravenous route.

solution to a volume of between 20 ml and 200 ml

Specialist medical literature should be consulted

is stable for up to 24 hours at room temperature

for guidance as to clinical experience in particular
conditions.
Imuran Injection, when reconstituted as directed, is
a very irritant solution with a pH of 10 - 12.
When the reconstituted solution is diluted as
directed below, the pH of the resulting solution

of one of the following infusion solutions, Imuran
(15°C to 25°C):
Sodium Chloride Intravenous Infusion BP
(0.45% w/v and 0.9% w/v)
Sodium Chloride (0.18% w/v) and Glucose
(4.0% w/v) Intravenous Infusion BP.

azathioprine

Read all of this leaflet carefully before you start
using this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
nurse or pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Imuran is and what it is used for
2. Before you have Imuran
3. How to have Imuran
4. Possible side effects
5. How to store Imuran
6. Further information
1 What Imuran is and what it is used for
Imuran injection contains a medicine called
azathioprine. This belongs to a group of medicines
called immunosuppressants. These medicines reduce
the activity of your body’s immune system.
Imuran is used to:
• stop your body rejecting an organ transplant
• treat diseases where your immune system reacts
against your own body (called autoimmune
diseases, such as rheumatoid arthritis).
Ask your doctor, nurse or pharmacist if you would like
any further explanation about these uses.
2 Before you have Imuran
Do not have Imuran if:

• you are allergic (hypersensitive) to azathioprine,
mercaptopurine or any of the other ingredients of
Imuran (listed in section 6).
If you are not sure, talk to your doctor, nurse or
pharmacist before having Imuran.

• developing a serious condition called Macrophage
Activation Syndrome (excessive activation of white
blood cells associated with inflammation), which
usually occurs in people who have certain types
of arthritis

Take special care with Imuran
Check with your doctor, nurse or pharmacist before
having Imuran if:
• you have liver or kidney disease
• you have ‘Lesch-Nyhan Syndrome’. This is a rare
condition that runs in families caused by a lack of
something called HPRT or ‘hypoxanthine-guaninephosphoribosyltransferase’
• you have a condition where your body produces
too little of something called TPMT or ‘thiopurine
methyltransferase’
• you have ever suffered from chickenpox or shingles.
If you are not sure if any of the above apply to you,
talk to your doctor, nurse or pharmacist before
having Imuran.

Taking other medicines
Please tell your doctor, nurse or pharmacist if
you are taking or have recently taken any other
medicines. This includes medicines obtained without
a prescription, including herbal medicines. This is
because Imuran can affect the way some medicines
work. Also some other medicines can affect the way
Imuran works.
In particular, tell your doctor, nurse or pharmacist if
you are taking any of the following medicines:
• allopurinol - used for gout
• tubocurarine or succinylcholine - used during
operations
• warfarin - used for blood clots
• penicillamine - used for rheumatoid arthritis
• co-trimoxazole - used for infections
• captopril - used for high blood pressure or
heart problems
• cimetidine - used for stomach ulcers and indigestion
• indomethacin - used for pain and inflammation
• furosemide - used for high blood pressure and
heart problems
• olsalazine or mesalazine - used for a bowel problem
called ulcerative colitis
• sulfasalzine or balsalazide - used for rheumatoid
arthritis or ulcerative colitis.
If you are not sure if any of the above apply to you,
talk to your doctor, nurse or pharmacist before
having Imuran.
Having vaccines while you are using Imuran
If you are going to have a vaccination speak to your
doctor or nurse before you have it. This is because
vaccines may not work properly while you are
having Imuran.

Talk to your doctor, pharmacist or nurse before
using Imuran
If you are receiving immunosuppressive therapy,
taking Imuran could put you at greater risk of:
• tumours, including skin cancer. Therefore, when
taking Imuran, avoid excessive exposure to sunlight,
wear protective clothing and use protective
sunscreen with a high protection factor.
• lymphoproliferative disorders
○○ treatment with Imuran increases your
risk of getting a type of cancer called
lymphoproliferative disorder. With
treatment regimen containing multiple
immunosuppressants (including thiopurines), this
may lead to death.
○○ A combination of multiple immunosuppressants,
given concomitantly increases the risk of
disorders of the lymph system due to a viral
infection (Epstein-Barr virus (EBV)-associated
lymphoproliferative disorders).
Taking Imuran could put you at greater risk of:

Tests you may have while having Imuran
Your doctor may ask you to have a blood test while
you are having Imuran. This is to check your blood cell

count. Your doctor may change your dose of Imuran
after the test.
Trying for a baby, pregnancy and breast-feeding
• Do not have Imuran if you are a man trying to have
a baby. This is because it may affect the baby.
• Do not have Imuran if you are a woman who is
pregnant or think you might become pregnant. This
is because it may affect the baby.
• Do not have Imuran if you are breast-feeding.
This is because small amounts may pass into the
mother’s milk.

Ask your doctor, midwife or pharmacist for advice
before taking any medicine, if you are pregnant or
breast-feeding.
Imuran and the sun
While having Imuran you may be more likely to
develop some types of cancers such as skin cancer.
Some people also become sensitive to sunlight which
can cause skin discolouration or a rash. Take care to
avoid too much sun, cover up and use sunscreen.
Chickenpox/Shingles infection
Infection with chickenpox or shingles can become
severe in patients taking immunosuppressive
medicine. Therefore you should avoid contact with
anyone suffering from chickenpox or shingles.
Important information about some of the
ingredients of Imuran Injection
Imuran injection contains sodium. Each 50 mg vial
contains 4.5 mg of sodium. If you are on a low
sodium diet, talk to your doctor, nurse or pharmacist
before you have Imuran.
3 How to take Imuran
The dose of Imuran you have depends on your illness
and how bad it is. The dose also depends on your
age, your weight and how well your liver and kidneys
are working. Your doctor will explain this to you.
To stop your body rejecting an organ transplant
On the first day
• the usual dose is up to 5 mg per kg of body weight.
For the rest of your treatment
• you will have between 1 and 4 mg per kg of body
weight each day.
For other conditions
At the start of your treatment
• you will have 1 to 3 mg per kg of body
weight each day
• your doctor may reduce your dose later.
If you have more Imuran than you should
Your doctor will give you Imuran so it is unlikely that
you will receive too much. If you think you have
been given too much or have missed a dose, tell your
doctor or nurse.

4 Possible side effects
Like all medicines, Imuran can cause side effects,
although not everybody gets them.
The following side effects may happen with
this medicine:
If you notice any of the following serious side
effects, talk to your specialist doctor or go to
hospital straight away:
• allergic reaction, the signs may include:
- general tiredness, dizziness, feeling sick (nausea),
being sick (vomiting) or diarrhoea
- high temperature (fever), shivering or chills
- redness of the skin or a skin rash
- pain in the muscles or joints
- changes in the amount and colour of the urine
(kidney problems)
- dizziness, confusion, feeling light headed or
weak, caused by low blood pressure
• you bruise more easily or notice any
unusual bleeding
• you have a high temperature (fever) or other signs
of an infection
• you feel extremely tired
• you notice lumps anywhere on your body
• you notice any changes to your skin, for example
blisters or peeling
• your health suddenly gets worse
• you come into contact with anyone who is suffering
from chickenpox or shingles.
If you notice any of the above, stop having Imuran
and see a doctor straight away.
Other side effects include:
Very common (affects more than 1 in 10 people)
• infections caused by a virus, fungus or bacteria
• reduction in your bone marrow function, which
may make you feel unwell or show up in your
blood tests
• low white blood cell level in your blood tests, which
may cause an infection.
Common (affects less than 1 in 10 people)
• low blood platelet level, which may cause you to

bruise or bleed easily.
Uncommon (affects less than 1 in 100 people)
• low red blood cell level, which may cause you to
be tired, get headaches, be short of breath when
exercising, feel dizzy and look pale
• inflammation of the pancreas, which may cause
you severe upper stomach pain, with feeling sick
(nausea) and being sick (vomiting)
• liver problems, which may cause pale stools, dark
urine, itchiness and yellowing of your skin and eyes.
Rare (affects less than 1 in 1,000 people)
• problems with your blood and bone marrow which
may cause weakness, tiredness, paleness, headaches,
sore tongue, breathlessness, bruising or infections
• problems with your bowel leading to diarrhoea,
abdominal pain, constipation, feeling sick (nausea)
and being sick (vomiting)
• hair loss which may get better even though you
continue to take Imuran
• severe liver damage which can be life-threatening
• various types of cancers including blood, lymph and
skin cancers
• sensitivity to sunlight which can cause skin
discolouration or a rash.
Very rare (affects less than 1 in 10,000 people)
• inflammation of your lungs causing breathlessness,
cough and a fever.
If any of the side effects gets serious, or if you notice
any other side effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist.
5 How to store Imuran





Do not store above 25°C.
Protect from light and keep dry.
Keep out of the reach and sight of children.
Do not use Imuran after the expiry date which is
stated on the label. The expiry date refers to the last
day of that month.
• Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to

dispose of medicines no longer required. These
measures will help to protect the environment.
6 Further Information
What Imuran contains
• The active substance is azathioprine.
Each Imuran injection contains 50 mg of
azathioprine.
• The other ingredient is sodium hydroxide.
• Before Imuran is injected it is diluted in sterile water.

Should any visible turbidity or crystallisation

Information for the physician leaflet date:

appear in the reconstituted or diluted solution the

November 2013

preparation must be discarded.

Imuran is a trademark of Aspen. All rights reserved.

Imuran Injection should only be reconstituted with
the recommended volume of Water for Injections
BP and should be diluted as specified above. Imuran
Injection should not be mixed with other drugs
or fluids, except those specified above, before

What Imuran looks like and contents of the pack
• Each pack contains one Imuran injection in
a glass vial.

administration.

Marketing Authorisation Holder and
Manufacturer
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Service-Tel: +800 00404142

3 years unopened

Manufacturer: GlaxoSmithKline Manufacturing S.p.A.,
San Polo Di Torrile, Parma, Italy

of an appropriate infusion solution and stored at

PL 39699/0003

Shelf Life

5 days when reconstituted with 5 ml to 15 ml water
for injections and stored at 5 to 25°C.
1 day for 5 ml of the reconstituted injection
further diluted with between 20 ml and 200 ml
15°C to 25°C.

Leaflet date: February 2017

Special Precautions for Storage

Imuran is a trademark of Aspen. All rights reserved.

• Store below 25°C
• Keep dry
• Protect from light
Instructions for Use/Handling
Health professionals who handle Imuran Injection
should follow guidelines for the handling of cytotoxic
drugs according to prevailing local recommendations
and/or regulations (e.g., the Royal Pharmaceutical
Society of Great Britain Working Party Report on the
Handling of Cytotoxic Drugs, 1983).

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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