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IMURAN INJECTION 50MG/VIAL

Active substance(s): AZATHIOPRINE

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Information for the Physician

Imuran® Injection
azathioprine

Please refer to the Summary of Product
Characteristics (SPC) for further details on this
product.
Trade Name of the Medicinal Product

When the reconstituted solution is
diluted as directed below, the pH of
the resulting solution may be expected
to be within the range pH 8.0 to 9.5
(the greater the dilution, the lower the pH).
Where dilution is not practicable, the
reconstituted solution should be injected slowly
over a period of not less than one minute and
followed immediately by not less than 50 ml of
one of the recommended infusion solutions.
Care must be taken to avoid perivenous
injection, which may produce tissue damage.

Imuran Injection

Reconstitution and dilution of Imuran Injection

Qualitative and Quantitative Composition

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

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 administered only by the
intravenous route.
Specialist medical literature should be consulted
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.

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 solution to a volume of between
20 ml and 200 ml of one of the following
infusion solutions, Imuran is stable for up to 24
hours at room temperature (15°C to 25°C):
Sodium Chloride Intravenous Infusion BP
(0.45% w/v and 0.9% w/v)

Ask your doctor, nurse or pharmacist if you would
like any further explanation about these uses.
Package Leaflet: Information for the User

Imuran® Injection
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).

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.
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.
NUDT15-gene mutation
If you have an inherited mutation in the
NUDT15-gene (a gene which is involved in the
break-down of Imuran in the body), you have a
higher risk of infections and hair loss and your
doctor may in this case give you a lower dose.
If you are not sure if any of the above apply to
you, talk to your doctor, nurse or pharmacist
before 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
o 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.
o 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:
• 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
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.
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
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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.
What Imuran looks like and contents of the
pack
• Each pack contains one Imuran injection in a
glass vial.
Marketing Authorisation Holder and
Manufacturer
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Service-Tel: +800 00404142
Manufacturer: GlaxoSmithKline Manufacturing
S.p.A., San Polo Di Torrile, Parma, Italy
PL 39699/0003

Sodium Chloride (0.18% w/v) and Glucose
(4.0% w/v) Intravenous Infusion BP.

Information for the physician leaflet date:
March 2018

Should any visible turbidity or crystallisation
appear in the reconstituted or diluted solution
the 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 administration.
Shelf Life
3 years unopened
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
of an appropriate infusion solution and stored
at 15°C to 25°C.
Special Precautions for Storage
• Store below 25°C
• Keep dry
• Protect from light
Instructions for Use/Handling

Leaflet date: March 2018
Imuran is a trademark of Aspen. All rights
reserved.

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).

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