ENOXAPARIN SODIUM SOLUTION FOR INJECTION

Active substance: SODIUM ENOXAPARIN

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CLEXANE® 20mg SYRINGE
CLEXANE® 40mg SYRINGE
CLEXANE® 60mg SYRINGE
CLEXANE® 80mg SYRINGE
CLEXANE® 100mg SYRINGE
(enoxaparin sodium)
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 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 get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side-effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is used for
The name of your medicine is Clexane 20mg, 40mg,
60mg, 80mg and 100mg Syringe but throughout this
leaflet it will be referred to as Clexane. Clexane
contains a medicine called enoxaparin sodium. This
belongs to a group of medicines called Low Molecular
Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting any bigger.
This helps your body to break them down and stop them
causing you harm.
2) Stopping blood clots forming in your blood.
Clexane can be used to:
 Treat blood clots that are in your blood
 Stop blood clots forming in your blood in the
following situations:
o Unstable angina (where not enough blood gets
to your heart)
o After an operation or long periods of bed rest
due to illness
o After you have had a heart attack
 Stop blood clots forming in the tubes of your dialysis
machine (used for people with kidney problems)
2. Before you use Clexane
Do not have this medicine and tell your doctor,
pharmacist or nurse if:
 You are allergic (hypersensitive) to enoxaparin
sodium or any of the other ingredients of Clexane
(listed in Section 6: Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
 You are allergic to heparin or other Low Molecular
Weight Heparins such as tinzaparin or dalteparin
 You have a problem with bruising or bleeding too
easily
 You have an ulcer in your stomach or gut (intestine)
 You have had a stroke caused by bleeding in the
brain
 You have an infection in your heart
 You are using the medicine called heparin to treat
blood clots
Do not have this medicine if any of the above apply to
you. If you are not sure, talk to your doctor, pharmacist
or nurse before having Clexane.

Take special care with Clexane
Check with your doctor or pharmacist or nurse
before using this medicine if:
 You have high blood pressure
 You have kidney problems
 You have had a heart valve fitted
 You have ever had bruising and bleeding caused by
the medicine ‘heparin’
 You have ever had a stroke
 You have ever had a stomach ulcer
 You have recently had an operation on your eyes or
brain
 You are a diabetic or have a illness known as
‘diabetic retinopathy’ (problems with the blood
vessels in the eye caused by diabetes)
 You have any problems with your blood
 You are underweight or overweight
 You are elderly (over 65 years old) and especially if
you are aged over 75 years old
If you are not sure if any of the above applies to you,
talk to your doctor or pharmacist or nurse before using
Clexane.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are
taking or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines. This is because Clexane
can affect the way some other medicines work. Also
some medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your
doctor if:
 You are using the medicine called heparin to treat
blood clots
Tell your doctor if you are taking any of the
following medicines:
 Warfarin - used for thinning the blood
 Aspirin, dipyridamole, clopidogrel or other medicines
- used to stop blood clots forming
 Dextran injection - used as a blood replacer
 Ibuprofen, diclofenac, ketorolac or other medicines used to treat pain and swelling in arthritis and other
illnesses
 Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other
conditions
 Water tablets (diuretics) such as spironolactone,
triamterene or amiloride. These may increase the
levels of potassium in your blood when taken with
Clexane
Your doctor may change one of your medicines or take
regular blood tests to check that taking these medicines
with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an
operation where an epidural or spinal anaesthetic is
used, tell your doctor that you are using Clexane. Tell
also your doctor if you have any problem with your spine
or if you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine if you
are pregnant, might become pregnant, or think you may
be pregnant.
You should not use this medicine if you are pregnant
and have a mechanical heart valve as you may be at
increased risk of developing blood clots. Your doctor
should discuss this with you.
You should not breast-feed whilst using Clexane. If you
are planning to breast-feed, talk to your doctor,
pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.

3. How to use Clexane
Having this medicine
 Before you use Clexane your doctor or nurse may
carry out a blood test
 While you are in hospital your doctor or nurse will
normally give you Clexane. This is because it needs
to be given as an injection
 When you go home you may need to continue to use
Clexane and give it to yourself (see below
instructions on how to do this)
 Clexane is usually given by injection underneath the
skin (subcutaneous)
If you are not sure why you are receiving Clexane or
have any questions about how much Clexane is being
given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you
 Your doctor will decide how much to give you. The
amount of Clexane given to you will depend on the
reason it is being used
 If you have problems with your kidneys, you may be
given a smaller amount of Clexane
1) Treating blood clots that are in your blood
 The usual dose is 1.5mg for every kilogram of your
weight, each day
 Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in
the following situations:
a) Unstable angina
 The usual amount is 1mg for every kilogram of
weight, every 12 hours
 Clexane will usually be given for 2 to 8 days. Your
doctor will normally ask you to take aspirin as well
b) After an operation or long periods of bedrest
due to illness
The usual dose is 20mg or 40mg each day. The dose
will depend on how likely you are to develop a clot
 If you have a low to medium risk of getting a clot,
you will be given 20mg of Clexane each day. If you
are going to have an operation, your first injection
will usually be given 2 hours before your operation
 If you have a higher risk of getting a clot, you will
be given 40mg each day. If you are going to have
an operation, your first injection will usually be
given 12 hours before your operation
 If you are bedridden due to illness, you will be
normally be given 40mg of Clexane each day for 6
to 14 days

If you are aged 75 years or older
 Your doctor or nurse will give you injections of
Clexane under your skin (subcutaneous injection)
 The usual dose is 0.75mg for every kilogram of
your weight, every 12 hours
 The maximum amount of Clexane given for the
first two injections is 75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
 Depending on when you were last given Clexane,
your doctor may decide to give an additional dose
of Clexane before a PCI operation. This is by
injection into your vein (intravenous using Clexane
Multidose Vial or 60, 80 or 100mg Pre-filled
syringes)
3) Stop blood clots forming in the tubes of your
dialysis machine
 The usual dose is 1 mg for every kilogram of your
weight
 Clexane is added to the tube leaving the body
(arterial line) at the start of the dialysis session
 This amount is usually enough for a 4 hour
session. However, your doctor may give you a
further dose of 0.5 to 1mg for every kilogram of
your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your doctor
or nurse will show you how to do this. Do not try to inject
yourself if you have not been trained how to do so. If
you are not sure what to do, talk to your doctor or nurse
immediately.
Before injecting yourself with Clexane
 Check the expiry date on the medicine. Do not use if
the date has passed
 Check the syringe is not damaged and the medicine
in it is a clear solution. If not, use another syringe
 Make sure you know how much you are going to
inject
 Check your abdomen to see if the last injection
caused any redness, change in skin colour, swelling,
oozing or is still painful, if so talk to your doctor or
nurse
 Decide where you are going to inject the medicine.
Change the place where you inject each time from
the right to the left side of your stomach. Clexane
should be injected just under the skin on your
stomach, but not too near the belly button or any
scar tissue (at least 5 cm away from these)
Instructions on injecting yourself with Clexane:
1) Wash your hands and the area that you will inject with
soap and water. Dry them.

c) After you have had a heart attack
Clexane can be used for two different types of heart
attack called NSTEMI or STEMI. The amount of
Clexane given to you will depend on your age and the
kind of heart attack you have had.
i)



NSTEMI type of heart attack
The usual amount is 1mg for every kilogram of
weight, every 12 hours
Clexane will usually be given for 2 to 8 days. Your
doctor will normally ask you to take aspirin as well

ii) STEMI type of heart attack
If you are under 75 years old
 30mg of Clexane will be given as an injection into
your vein (intravenous injection using Clexane
Multidose Vial or 60, 80 or 100mg Pre-filled
syringes)
 At the same time, you will also be given Clexane
as an injection under your skin (subcutaneous
injection). The usual dose is 1mg for every
kilogram of your weight.
 Then you will be given 1mg for every kilogram of
your weight every 12 hours after that
 The maximum amount of Clexane given for the
first two injections is 100mg
 The injections will normally be given for up to 8
days

2) Sit or lie in a comfortable position so you are relaxed.
Make sure you can see the place you are going to inject.
A lounge chair, recliner, or bed propped up with pillows
is ideal.

3) Choose an area on the right or left side of your
stomach. This should be at least 5 centimetres away
from your belly button and out towards your sides.
Remember: Do not inject yourself within 5 centimetres
of your belly button or around existing scars or bruises.
Change the place where you inject between the left and
right sides of your stomach, depending on the area you
were last injected.

4) Carefully pull off the needle cap from the Clexane
syringe. Throw away the cap. The syringe is pre-filled
and ready to use.

5) Hold the syringe in the hand you write with (like a
pencil) and with your other hand, gently pinch the
cleaned area of your abdomen between your forefinger
and thumb to make a fold in the skin

Rare (affects less than 1 in a 1000 people)
 Changes in the potassium levels in your blood. This
is more likely to happen in people with kidney
problems or diabetes. Your doctor will be able to
check this by carrying out a blood test.

If you stop using Clexane
It is important for you to keep having Clexane injections
until your doctor decides to stop them. If you stop, you
could get a blood clot which can be very dangerous.
Do not press on the plunger before injecting yourself to
get rid of air bubbles. This can lead to a loss of the
medicine. Once you have removed the cap, do not allow
the needle to touch anything. This is to make sure the
needle stays clean (sterile).

If you forget to use Clexane
If you forget to give yourself a dose, have it as soon as
you remember. Do not give yourself a double dose on
the same day to make up for a forgotten dose. Keeping
a diary will help to make sure you do not miss a dose

Frequency unknown
 If Clexane is used for a long period of time (more
than 3 months), it may increase the risk of you
getting a condition called ‘osteoporosis’. This is when
your bones are more likely to break
 Headache
 Hair loss

Blood Tests
Using Clexane may affect the results of some blood
tests. If you are going to have a blood test, it is
important to tell your doctor you are having Clexane.
4. Possible side-effects
Like all medicines, Clexane can cause side-effects,
although not everybody gets them.
Tell a nurse or doctor or go to hospital straight away
if you notice any of the following side-effects:
Very common (affects more than 1 in 10 people)
 Bleeding a lot from a wound.

Make sure you hold the skin fold throughout the
injection.
6) Hold the syringe so that the needle is pointing
downwards (vertically at a 90º angle). Insert the full
length of the needle into the skin fold
7) Press down on the plunger with your finger. This will
send the medication into the fatty tissue of the stomach.
Make sure you hold the skin fold throughout the injection

Common (affects 1 to 10 people in a 100)
 A painful rash of dark red spots under the skin which
do not go away when you put pressure on them. You
may also notice pink patches on your skin. These
are more likely to appear in the area you have been
injected with Clexane.

Frequency unknown
 If you have had a spinal puncture or a spinal
anaesthetic and notice tingling, numbness and
muscular weakness, particularly in the lower part of
your body. Also if you lose control over your bladder
or bowel (so you cannot control when you go to the
toilet).
Tell a nurse or doctor as soon as possible if you
notice any of the following side effects:
Common (affects 1 to 10 people in a 100)
 You bruise more easily than usual. This could be
because of a blood problem (thrombocytopenia).
 You have pain, swelling or irritation in the area you
have been injected with Clexane. This normally gets
better after a few days.

Note: the safety system allowing release of the
protective sleeve, can only be activated when the
syringe has been emptied by pressing the plunger all
the way down.
To avoid bruising, do not rub the injection site after
you have injected yourself.
9) Drop the used syringe with its protective sleeve into
the sharps bin provided. Close the container lid tightly
and place the container out of reach of children.
When the container is full, give it to your doctor or
home care nurse for disposal. Do not put it in the
household rubbish.
If you have more Clexane than you should
If you think that you have used too much or too little
Clexane, tell your doctor, nurse or pharmacist
immediately, even if you have no signs of a problem. If a
child accidentally injects or swallows Clexane, take them
to a hospital casualty department straight away.

5. How to store and dispose of Clexane
Keep this medicine in a safe place where children
cannot see or reach it
Do not use Clexane after the expiry date which is stated
on the carton. The expiry date refers to the last day of
that month.
Do not store above 25°C. Do not refrigerate or freeze.

Uncommon (affects 1 to 10 people in a 1,000)
 Sudden severe headache. This could be a sign of
bleeding in the brain.
 A feeling of tenderness and swelling in your
stomach. You may have bleeding inside your
stomach.
Rare (affects less than 1 in a 1000 people)
 If you have an allergic reaction. The signs may
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.

8) Remove the needle by pulling it straight out. A
protective sleeve will automatically cover the needle.
You can now let go of the skin fold.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

Rare (affects less than 1 in a 1000 people)
 If you have a mechanical heart valve, treatment with
Clexane might not be sufficient to prevent blood
clots. You may notice that you have difficulty
breathing, tiredness or difficulty exercising, chest
pain, numbness, feeling sick or loss of
consciousness. This could be due to a blood clot on
the heart valve
Frequency unknown
 Feeling tired, faint, dizzy, having pale skin. These
could be symptoms of anaemia.
 You notice yellowing of your skin or eyes and your
urine becomes darker in colour. This could be a liver
problem.
Other side effects that you should discuss with your
nurse or doctor if you are concerned about them:
Very common (affects more than 1 in 10 people)
 Changes in the results of blood tests done to check
how your liver is working. These usually go back to
normal after you stop having Clexane.

Medicines should not be disposed of via wastewater or
household waste. If you are using this medicine at home
you will be given a container (a sharps bin) to use for
disposal. Return the sharps bin or any used or unused
syringes to your doctor or nurse or pharmacist for
disposal. These measures will help to protect the
environment.
6. Further Information
What Clexane contains

Clexane 20 mg syringe contains 20mg enoxaparin
sodium per (Anti-Factor Xa activity 2,000 IU) in
0.2ml water for injection.

Clexane 40 mg syringe contains 40mg enoxaparin
sodium (Anti-Factor Xa activity 4,000 IU) in 0.4ml
water for injection.

Clexane 60 mg syringe contains 60mg enoxaparin
sodium per (Anti-Factor Xa activity 6,000 IU) in
0.6ml water for injection.

Clexane 80 mg syringe contains 80mg enoxaparin
sodium (Anti-Factor Xa activity 8,000 IU) in 0.8ml
water for injection.

Clexane 100 mg syringe contains 100mg
enoxaparin sodium (Anti-Factor Xa activity 10,000
IU) in 1.0ml water for injection.
What Clexane Pre-filled Syringes looks like and
contents of the pack
Clexane comes in the form of a clear solution for
injection in a glass pre-filled syringe fitted with injection
needles, a spring loaded plunger and safety lock system
and are packed into boxes of 10.
Manufacturer
Clexane is 20mg and Clexane 40mg is manufactured by
Aventis Pharma Le Trait, Boulevard Industrial, Le Trait,
F-76580, France
or
Chinoin Pharmaceutical and Chemical Works Private
Co. Ltd., HU-1045 Budapest, Hungary
or
Sanofi Winthrop Industrie, 82 Avenue Raspail, F-94250
Gentilly, France
or
Sanofi Winthrop Industrie, 20 Avenue Raymond Aron,
F-92160 Antony, France

Clexane 60mg, 80mg and 100mg is manufactured by
Chinoin Pharmaceutical and Chemical Works Private
Co. Ltd., HU-1045 Budapest, Hungary
or
Chinoin Pharmaceutical and Chemical Works Co. Ltd,
3510 Miskolc, Csanyikolgy, Hungary.
Procured from within the EU and repackaged in the UK
by the Product Licence holder, CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts WD6
1EE.
Clexane Syringe

20492/0350

POM

This leaflet does not contain all the information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
Clexane is a trademark of Aventis Pharma SA.
Date of revision: 11th June 2014

ENOXAPARIN SODIUM 20mg
SOLUTION FOR INJECTION
ENOXAPARIN SODIUM 40mg
SOLUTION FOR INJECTION
ENOXAPARIN SODIUM 60mg
SOLUTION FOR INJECTION
ENOXAPARIN SODIUM 80mg
SOLUTION FOR INJECTION
ENOXAPARIN SODIUM 20mg
SOLUTION FOR INJECTION
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 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 get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist
In this leaflet:
1. What Enoxaparin Sodium is and what it is used for
2. Before you use Enoxaparin Sodium
3. How to use Enoxaparin Sodium
4. Possible side-effects
5. How to store Enoxaparin Sodium
6. Further information
1. What Enoxaparin Sodium is and what it is
used for
The name of your medicine is Enoxaparin Sodium
20mg, 40mg, 60mg, 80mg and 100mg solution for
injection but throughout this leaflet it will be referred to
as Enoxaparin Sodium. Enoxaparin Sodium contains a
medicine called enoxaparin sodium. This belongs to a
group of medicines called Low Molecular Weight
Heparins.
Enoxaparin Sodium works in two ways.
1) Stopping existing blood clots from getting any bigger.
This helps your body to break them down and stop them
causing you harm.
2) Stopping blood clots forming in your blood.
Enoxaparin Sodium can be used to:
 Treat blood clots that are in your blood
 Stop blood clots forming in your blood in the
following situations:
o Unstable angina (where not enough blood gets
to your heart)
o After an operation or long periods of bed rest
due to illness
o After you have had a heart attack
 Stop blood clots forming in the tubes of your dialysis
machine (used for people with kidney problems)
2. Before you use Enoxaparin Sodium
Do not have this medicine and tell your doctor,
pharmacist or nurse if:
 You are allergic (hypersensitive) to enoxaparin
sodium or any of the other ingredients of Enoxaparin
Sodium (listed in Section 6: Further information)
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
 You are allergic to heparin or other Low Molecular
Weight Heparins such as tinzaparin or dalteparin
 You have a problem with bruising or bleeding too
easily
 You have an ulcer in your stomach or gut (intestine)
 You have had a stroke caused by bleeding in the
brain
 You have an infection in your heart
 You are using the medicine called heparin to treat
blood clots


Do not have this medicine if any of the above apply to
you. If you are not sure, talk to your doctor, pharmacist
or nurse before having Enoxaparin Sodium.
Take special care with Enoxaparin Sodium
Check with your doctor or pharmacist or nurse
before using this medicine if:
 You have high blood pressure
 You have kidney problems
 You have had a heart valve fitted
 You have ever had bruising and bleeding caused by
the medicine ‘heparin’
 You have ever had a stroke
 You have ever had a stomach ulcer
 You have recently had an operation on your eyes or
brain
 You are a diabetic or have a illness known as
‘diabetic retinopathy’ (problems with the blood
vessels in the eye caused by diabetes)
 You have any problems with your blood
 You are underweight or overweight
 You are elderly (over 65 years old) and especially if
you are aged over 75 years old
If you are not sure if any of the above applies to you,
talk to your doctor or pharmacist or nurse before using
Enoxaparin Sodium.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are
taking or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines. This is because Enoxaparin
Sodium can affect the way some other medicines work.
Also some medicines can affect the way Enoxaparin
Sodium works.
In particular, do not have this medicine and tell your
doctor if:
 You are using the medicine called heparin to treat
blood clots
Tell your doctor if you are taking any of the
following medicines:
 Warfarin - used for thinning the blood
 Aspirin, dipyridamole, clopidogrel or other medicines
- used to stop blood clots forming
 Dextran injection - used as a blood replacer
 Ibuprofen, diclofenac, ketorolac or other medicines used to treat pain and swelling in arthritis and other
illnesses
 Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other
conditions
 Water tablets (diuretics) such as spironolactone,
triamterene or amiloride. These may increase the
levels of potassium in your blood when taken with
Enoxaparin Sodium
Your doctor may change one of your medicines or take
regular blood tests to check that taking these medicines
with Enoxaparin Sodium is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an
operation where an epidural or spinal anaesthetic is
used, tell your doctor that you are using Enoxaparin
Sodium. Tell also your doctor if you have any problem
with your spine or if you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine if you
are pregnant, might become pregnant, or think you may
be pregnant.
You should not use this medicine if you are pregnant
and have a mechanical heart valve as you may be at
increased risk of developing blood clots. Your doctor
should discuss this with you.
You should not breast-feed whilst using Enoxaparin
Sodium. If you are planning to breast-feed, talk to your
doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking
any medicine if you are pregnant or breast-feeding.

3. How to use Enoxaparin Sodium
Having this medicine
 Before you use Enoxaparin Sodium your doctor or
nurse may carry out a blood test
 While you are in hospital your doctor or nurse will
normally give you Enoxaparin Sodium. This is
because it needs to be given as an injection
 When you go home you may need to continue to use
Enoxaparin Sodium and give it to yourself (see
below instructions on how to do this)
 Enoxaparin Sodium is usually given by injection
underneath the skin (subcutaneous)
If you are not sure why you are receiving Enoxaparin
Sodium or have any questions about how much
Enoxaparin Sodium is being given to you, speak to your
doctor, pharmacist or nurse.
How much will be given to you
 Your doctor will decide how much to give you. The
amount of Enoxaparin Sodium given to you will
depend on the reason it is being used
 If you have problems with your kidneys, you may be
given a smaller amount of Enoxaparin Sodium
1) Treating blood clots that are in your blood
 The usual dose is 1.5mg for every kilogram of your
weight, each day
 Enoxaparin Sodium will usually be given for at
least 5 days
2) Stopping blood clots forming in your blood in
the following situations:
a) Unstable angina
 The usual amount is 1mg for every kilogram of
weight, every 12 hours
 Enoxaparin Sodium will usually be given for 2 to 8
days. Your doctor will normally ask you to take
aspirin as well
b) After an operation or long periods of bedrest
due to illness
The usual dose is 20mg or 40mg each day. The dose
will depend on how likely you are to develop a clot
 If you have a low to medium risk of getting a clot,
you will be given 20mg of Enoxaparin Sodium each
day. If you are going to have an operation, your
first injection will usually be given 2 hours before
your operation
 If you have a higher risk of getting a clot, you will
be given 40mg each day. If you are going to have
an operation, your first injection will usually be
given 12 hours before your operation
 If you are bedridden due to illness, you will be
normally be given 40mg of Enoxaparin Sodium
each day for 6 to 14 days
c) After you have had a heart attack
Enoxaparin Sodium can be used for two different
types of heart attack called NSTEMI or STEMI. The
amount of Enoxaparin Sodium given to you will
depend on your age and the kind of heart attack you
have had.
i) NSTEMI type of heart attack
 The usual amount is 1mg for every kilogram of
weight, every 12 hours
 Enoxaparin Sodium will usually be given for 2 to 8
days. Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
 30mg of Enoxaparin Sodium will be given as an
injection into your vein (intravenous injection using
Enoxaparin Sodium Multidose Vial or 60, 80 or
100mg Pre-filled syringes)
 At the same time, you will also be given
Enoxaparin Sodium as an injection under your
skin (subcutaneous injection). The usual dose is
1mg for every kilogram of your weight.
 Then you will be given 1mg for every kilogram of
your weight every 12 hours after that
 The maximum amount of Enoxaparin Sodium
given for the first two injections is 100mg

The injections will normally be given for up to 8
days
If you are aged 75 years or older
 Your doctor or nurse will give you injections of
Enoxaparin Sodium under your skin
(subcutaneous injection)
 The usual dose is 0.75mg for every kilogram of
your weight, every 12 hours
 The maximum amount of Enoxaparin Sodium
given for the first two injections is 75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
 Depending on when you were last given
Enoxaparin Sodium, your doctor may decide to
give an additional dose of Enoxaparin Sodium
before a PCI operation. This is by injection into
your vein (intravenous using Enoxaparin Sodium
Multidose Vial or 60, 80 or 100mg Pre-filled
syringes)
3) Stop blood clots forming in the tubes of your
dialysis machine
 The usual dose is 1 mg for every kilogram of your
weight
 Enoxaparin Sodium is added to the tube leaving
the body (arterial line) at the start of the dialysis
session
 This amount is usually enough for a 4 hour
session. However, your doctor may give you a
further dose of 0.5 to 1mg for every kilogram of
your weight if necessary
How to give yourself an injection of Enoxaparin
Sodium
If you are able to give Enoxaparin Sodium to yourself,
your doctor or nurse will show you how to do this. Do
not try to inject yourself if you have not been trained how
to do so. If you are not sure what to do, talk to your
doctor or nurse immediately.
Before injecting yourself with Enoxaparin Sodium
 Check the expiry date on the medicine. Do not use if
the date has passed
 Check the syringe is not damaged and the medicine
in it is a clear solution. If not, use another syringe
 Make sure you know how much you are going to
inject
 Check your abdomen to see if the last injection
caused any redness, change in skin colour, swelling,
oozing or is still painful, if so talk to your doctor or
nurse
 Decide where you are going to inject the medicine.
Change the place where you inject each time from
the right to the left side of your stomach. Enoxaparin
Sodium should be injected just under the skin on
your stomach, but not too near the belly button or
any scar tissue (at least 5 cm away from these)
Instructions on injecting yourself with Enoxaparin
Sodium:
1) Wash your hands and the area that you will inject with
soap and water. Dry them.

2) Sit or lie in a comfortable position so you are relaxed.
Make sure you can see the place you are going to inject.
A lounge chair, recliner, or bed propped up with pillows
is ideal.

To avoid bruising, do not rub the injection site after
you have injected yourself.

3) Choose an area on the right or left side of your
stomach. This should be at least 5 centimetres away
from your belly button and out towards your sides.
Remember: Do not inject yourself within 5 centimetres
of your belly button or around existing scars or bruises.
Change the place where you inject between the left and
right sides of your stomach, depending on the area you
were last injected.
4) Carefully pull off the needle cap from the Enoxaparin
Sodium syringe. Throw away the cap. The syringe is
pre-filled and ready to use.

Do not press on the plunger before injecting yourself to
get rid of air bubbles. This can lead to a loss of the
medicine. Once you have removed the cap, do not allow
the needle to touch anything. This is to make sure the
needle stays clean (sterile).
5) Hold the syringe in the hand you write with (like a
pencil) and with your other hand, gently pinch the
cleaned area of your abdomen between your forefinger
and thumb to make a fold in the skin

9) Drop the used syringe with its protective sleeve into
the sharps bin provided. Close the container lid tightly
and place the container out of reach of children.
When the container is full, give it to your doctor or
home care nurse for disposal. Do not put it in the
household rubbish.
If you have more Enoxaparin Sodium than you
should
If you think that you have used too much or too little
Enoxaparin Sodium, tell your doctor, nurse or
pharmacist immediately, even if you have no signs of a
problem. If a child accidentally injects or swallows
Enoxaparin Sodium, take them to a hospital casualty
department straight away.
If you forget to use Enoxaparin Sodium
If you forget to give yourself a dose, have it as soon as
you remember. Do not give yourself a double dose on
the same day to make up for a forgotten dose. Keeping
a diary will help to make sure you do not miss a dose
If you stop using Enoxaparin Sodium
It is important for you to keep having Enoxaparin
Sodium injections until your doctor decides to stop them.
If you stop, you could get a blood clot which can be very
dangerous.
Blood Tests
Using Enoxaparin Sodium may affect the results of
some blood tests. If you are going to have a blood test,
it is important to tell your doctor you are having
Enoxaparin Sodium.
4. Possible side-effects
Like all medicines, Enoxaparin Sodium can cause sideeffects, although not everybody gets them.

Make sure you hold the skin fold throughout the
injection.
6) Hold the syringe so that the needle is pointing
downwards (vertically at a 90º angle). Insert the full
length of the needle into the skin fold
7) Press down on the plunger with your finger. This will
send the medication into the fatty tissue of the stomach.
Make sure you hold the skin fold throughout the injection

Tell a nurse or doctor or go to hospital straight away
if you notice any of the following side-effects:
Very common (affects more than 1 in 10 people)
 Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
 A painful rash of dark red spots under the skin which
do not go away when you put pressure on them. You
may also notice pink patches on your skin. These
are more likely to appear in the area you have been
injected with Enoxaparin Sodium.
Uncommon (affects 1 to 10 people in a 1,000)
 Sudden severe headache. This could be a sign of
bleeding in the brain.
 A feeling of tenderness and swelling in your
stomach. You may have bleeding inside your
stomach.
Rare (affects less than 1 in a 1000 people)
 If you have an allergic reaction. The signs may
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.

Rare (affects less than 1 in a 1000 people)
 If you have a mechanical heart valve, treatment with
Enoxaparin Sodium might not be sufficient to prevent
blood clots. You may notice that you have difficulty
breathing, tiredness or difficulty exercising, chest
pain, numbness, feeling sick or loss of
consciousness. This could be due to a blood clot on
the heart valve
Frequency unknown
 Feeling tired, faint, dizzy, having pale skin. These
could be symptoms of anaemia.
 You notice yellowing of your skin or eyes and your
urine becomes darker in colour. This could be a liver
problem.
Other side effects that you should discuss with your
nurse or doctor if you are concerned about them:
Very common (affects more than 1 in 10 people)
 Changes in the results of blood tests done to check
how your liver is working. These usually go back to
normal after you stop having Enoxaparin Sodium.
Rare (affects less than 1 in a 1000 people)
 Changes in the potassium levels in your blood. This
is more likely to happen in people with kidney
problems or diabetes. Your doctor will be able to
check this by carrying out a blood test.
Frequency unknown
 If Enoxaparin Sodium is used for a long period of
time (more than 3 months), it may increase the risk
of you getting a condition called ‘osteoporosis’. This
is when your bones are more likely to break
 Headache
 Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store and dispose of Enoxaparin
Sodium
Keep this medicine in a safe place where children
cannot see or reach it
Do not use Enoxaparin Sodium after the expiry date
which is stated on the carton. The expiry date refers to
the last day of that month.
Do not store above 25°C. Do not refrigerate or freeze.
Medicines should not be disposed of via wastewater or
household waste. If you are using this medicine at home
you will be given a container (a sharps bin) to use for
disposal. Return the sharps bin or any used or unused
syringes to your doctor or nurse or pharmacist for
disposal. These measures will help to protect the
environment.
6. Further Information

8) Remove the needle by pulling it straight out. A
protective sleeve will automatically cover the needle.
You can now let go of the skin fold.

Note: the safety system allowing release of the
protective sleeve, can only be activated when the
syringe has been emptied by pressing the plunger all
the way down.

Frequency unknown
 If you have had a spinal puncture or a spinal
anaesthetic and notice tingling, numbness and
muscular weakness, particularly in the lower part of
your body. Also if you lose control over your bladder
or bowel (so you cannot control when you go to the
toilet).
Tell a nurse or doctor as soon as possible if you
notice any of the following side effects:
Common (affects 1 to 10 people in a 100)
 You bruise more easily than usual. This could be
because of a blood problem (thrombocytopenia).
 You have pain, swelling or irritation in the area you
have been injected with Enoxaparin Sodium. This
normally gets better after a few days.

What Enoxaparin Sodium contains

Enoxaparin Sodium 20 mg syringe contains 20mg
enoxaparin sodium per (Anti-Factor Xa activity
2,000 IU) in 0.2ml water for injection.

Enoxaparin Sodium 40 mg syringe contains 40mg
enoxaparin sodium (Anti-Factor Xa activity 4,000
IU) in 0.4ml water for injection.

Enoxaparin Sodium Solution for Injection 60 mg
contains 60mg enoxaparin sodium per (Anti-Factor
Xa activity 6,000 IU) in 0.6ml water for injection.

Enoxaparin Sodium Solution for Injection 80 mg
contains 80mg enoxaparin sodium (Anti-Factor Xa
activity 8,000 IU) in 0.8ml water for injection.

Enoxaparin Sodium Solution for Injection 100 mg
contains 100mg enoxaparin sodium (Anti-Factor
Xa activity 10,000 IU) in 1.0ml water for injection.

What Enoxaparin Sodium Pre-filled Syringes looks
like and contents of the pack
Enoxaparin Sodium comes in the form of a clear
solution for injection in a glass pre-filled syringe fitted
with injection needles, a spring loaded plunger and
safety lock system and are packed into boxes of 10.
Manufacturer
Enoxaparin Sodium 20mg and 40mg is manufactured by
Aventis Pharma Le Trait, Boulevard Industrial, Le Trait,
F-76580, France
or
Chinoin Pharmaceutical and Chemical Works Private
Co. Ltd., HU-1045 Budapest, Hungary
or
Sanofi Winthrop Industrie, 82 Avenue Raspail, F-94250
Gentilly, France
or
Sanofi Winthrop Industrie, 20 Avenue Raymond Aron,
F-92160 Antony, France
Enoxaparin Sodium 60mg, 80mg and 100mg is
manufactured by
Chinoin Pharmaceutical and Chemical Works Private
Co. Ltd., HU-1045 Budapest, Hungary
or
Chinoin Pharmaceutical and Chemical Works Co. Ltd,
3510 Miskolc, Csanyikolgy, Hungary.
Procured from within the EU and repackaged in the UK
by the Product Licence holder, CD Pharma Ltd, Unit 3,
Manor Point, Manor Way, Borehamwood, Herts WD6
1EE.
Enoxaparin Sodium Solution for Injection
20492/0350
POM
This leaflet does not contain all the information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist.
Date of revision: 11th June 2014

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

CLEXANE® SYRINGE
(enoxaparin sodium)

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight

1.
NAME OF THE MEDICINAL PRODUCT
Clexane Syringe

Syringe label

Dose (mg)

Injection volume
(ml)

100mg/ml
Solution for Injection
CLEXANE syringes

The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes

Kg
40

40mg / 0.4ml

40 bd

0.40

45
50
55
60

60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml

45 bd
50 bd
55 bd
60 bd

0.45
0.50
0.55
0.60

65
70
75
80

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

105
110
115
120

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

105 bd
110 bd
115 bd
120 bd

0.70
0.74
0.78
0.80

125
130
135
140
145
150

150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

125 bd
130 bd
135 bd
140 bd
145 bd
150 bd

0.84
0.88
0.90
0.94
0.98
1.00

The name of this medicine is Clexane Syringe but it will be referred to as Clexane throughout this
leaflet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
20mg injection

Enoxaparin sodium 20mg (equivalent to 2,000 IU anti-Xa activity) in 0.2mL Water
for Injections
40mg injection
Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4mL Water
for Injections
60mg injection
Enoxaparin sodium 60mg (equivalent to 6,000 IU anti-Xa activity) in 0.6mL Water
for Injections
80mg injection
Enoxaparin sodium 80mg (equivalent to 8,000 IU anti-Xa activity) in 0.8mL Water
for Injections
100mg injection
Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0mL
Water for Injections
For full list of excipients, see section 6.1

150mg/ml
Solution for Injection
CLEXANE Forte syringes

3.
PHARMACEUTICAL FORM
Solution for injection.
Clear solution.
4.2
Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20
mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of
thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery,
the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg).
Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is
established.

Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only,
followed by 1mg/kg dosing for the remaining doses). For dosage in patients 75 years of age, see
section 4.2 Posology and method of administration: Elderly.

100mg/ml
Solution for Injection
CLEXANE syringes

Kg

Syringe label

Dose (mg)

Patient weight

Kg

Syringe label

Dose (mg)

60 od

100mg/ml
Solution for Injection
CLEXANE syringes

40

40mg / 0.4ml

40 bd

45
50

80mg / 0.8ml
80mg / 0.8ml

67.5 od
75 od

45
50
55
60

60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml

45 bd
50 bd
55 bd
60 bd

82.5 od
90 od
97.5 od

65
70
75
80

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

105
110
115
120

120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)

105 bd (1)
110 bd (1)
115 bd (1)
120 bd (1)

0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1)

125
130
135
140
145
150

150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)

125 bd (1)
130 bd (1)
135 bd (1)
140 bd (1)
145 bd (1)
150 bd (1)

0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1)

0.825
0.90
0.975

70
75
80

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

105 od
112.5 od
120 od

0.70
0.76
0.80

85
90
95
100

150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

127.5 od
135 od
142.5 od
150 od

0.86
0.90
0.96
1.00

Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, administered
concurrently with oral aspirin (100 to 325mg once daily).
Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and
continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days.

Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged 75 years only)
Patient weight

Kg

Syringe label

0.75mg/kg
Dose (mg)

Adjusted
dosing (mg)

Injection
volume (ml)

100mg/ml
Solution for
Injection
CLEXANE
syringes

40
45
50
55
60
65
70
75
80

60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml

30 bd
33.75 bd
37.5 bd
41.25 bd
45 bd
48.75 bd
52.5 bd
56.25 bd
60 bd

30 bd
35 bd
37.5 bd
42.5 bd
45 bd
50 bd
52.5 bd
57.5 bd
60 bd

0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60

85
90
95
100
105

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml

63.75 bd
67.5 bd
71.25 bd
75 bd
78.75 bd (1)

65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)

0.65
0.675
0.725
0.75
0.80 (1)

110
115
120
125
130

100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

82.5 bd (1)
86.25 bd (1)
90 bd (1)
93.75 bd (1)
97.5 bd (1)

82.5 bd (1)
87.5 bd (1)
90 bd (1)
95 bd (1)
97.5 bd (1)

0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)

135
140
145
150

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

101.25 bd (1)
105 bd (1)
108.75 bd (1)
112.5 bd (1)

102 bd (1)
105 bd (1)
111 bd (1)
114 bd (1)

0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1)

0.45
0.50
0.55
0.60

0.675
0.75

100mg / 1ml
100mg / 1ml
100mg / 1ml

Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients 75 years of
age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg
for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is
impaired (see also section 4.2 Posology and method of administration: Renal impairment; section 4.4
Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment, and
Monitoring; section 5.2 Pharmacokinetic properties).

0.40

0.60

55
60
65
150mg/ml
Solution for Injection
CLEXANE Forte syringes

60mg / 0.6ml

Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis
session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than
normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a
high risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular
access or 0.75 mg/kg (75 IU/kg) for single vascular access.

Injection volume
(ml)

Injection volume
(ml)

40

The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
SC administration was given less than 8 hours before balloon inflation, no additional dosing is
needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV
bolus of 0.3mg/kg of enoxaparin sodium should be administered.

Dosage chart for 1mg/kg SC treatment of STEMI

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient weight

When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin
sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic
therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having
STEMI and maintained under (75 to 325mg once daily) unless contraindicated.

150mg/ml
Solution for Injection
CLEXANE Forte syringes

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by
1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.

150mg/ml
Solution for
Injection
CLEXANE
Forte syringes

(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by
0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment
and Monitoring; section 5.2 Pharmacokinetic properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30
ml/min), according to the following tables, since enoxaparin sodium exposure is significantly
increased in this patient population:

Dosage adjustments for therapeutic dosage range
Standard dosing

Severe renal impairment

1 mg/kg SC twice daily

1 mg/kg SC once daily

1.5 mg/kg SC once daily

1 mg/kg SC once daily

To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to
use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as
follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete
contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml remaining in the bag. Gently
mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for
administration into the intravenous line (using an appropriate injection site or port).

For treatment of acute STEMI in patients <75 years of age
After dilution is completed, the volume to be injected can be calculated using the following formula
[Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is
recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use.

30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg twice daily.
(Max 100mg for each of the first two SC doses)

30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg once daily.
(Max 100mg for first SC dose only)

For treatment of acute STEMI in elderly patients

75 years of age

Volume to be injected through intravenous line after dilution is completed

0.75mg/kg SC twice daily without initial bolus.
(Max 75mg for each of the first two SC doses)

1mg/kg SC once daily without initial bolus.
(Max 100mg for first SC dose only)

Weight
[Kg]

Required dose
(0.3 mg/kg)
[mg]

Volume to inject when diluted to a final concentration of 3
mg/ml
[ml]

45

13.5

4.5

50

15

5

55

16.5

5.5

60

18

6

The recommended dosage adjustments do not apply to the haemodialysis indication.

65

19.5

6.5

Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment
(creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min),
careful clinical monitoring is advised.

70

21

7

75

22.5

7.5

80

24

8

Hepatic impairment: In the absence of clinical studies, caution should be exercised.

85

25.5

8.5

Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4
Special warnings and precautions for use: Low body weight and Monitoring; section 5.2
Pharmacokinetic properties).

90

27

9

95

28.5

9.5

100

30

10

105

31.5

10.5

110

33

11

115

34.5

11.5

120

36

12

To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic
safety device

125

37.5

12.5

130

39

13

Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be administered when
the patient is lying down by deep subcutaneous injection. The administration should be alternated
between the left and right anterolateral or posterolateral abdominal wall. The whole length of the
needle should be introduced vertically into a skin fold held between the thumb and index finger. The
skin fold should not be released until the injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects the
used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.

135

40.5

13.5

140

42

14

145

43.5

14.5

150

45

15

Dosage adjustments for prophylactic dosage ranges
Standard dosing

Severe renal impairment

40 mg SC once daily

20 mg SC once daily

20 mg SC once daily

20 mg SC once daily

Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic
disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave
myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial line
of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during
haemodialysis; and via intravenous (bolus) injection through an intravenous line only for the initial
dose of acute STEMI indication and before PCI when needed. It must not be administered by the
intramuscular route.

Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be
used. Enoxaparin sodium should be administered through an intravenous line. It should not be mixed
or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with
all other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or
dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium to
clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution
(0.9%) or 5% dextrose in water.
 Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or
100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The 30mg dose can
then be directly injected into an injection site in the intravenous line.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Water for Injections

6.2

Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in
dextrose in water.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers – discard any unused product

6.5

Nature and contents of container
Solution for injection in Type 1 glass pre-filled syringes fitted with injection needle and an
automatic safety device in packs of 10.

6.6

Special precautions for disposal
See section 4.2 Posology and method of administration.



Additional bolus for PCI when last SC administration was given more than 8 hours before
balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of
0.3mg/kg is to be administered if last SC administration was given more than 8 hours before balloon
inflation (see section 4.2 Posology and method of administration: Treatment of acute ST-segment
Elevation Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the
drug to 3mg/ml.

10
DATE OF REVISION OF THE TEXT
11th June 2014

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

ENOXAPARIN SODIUM SOLUTION FOR INJECTION
The following information is extracted from the SPC
Technical information for the administration of Enoxaparin Sodium Solution for Injection
1.
NAME OF THE MEDICINAL PRODUCT
Enoxaparin Sodium Solution for Injection

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight

Kg

Syringe label

Dose (mg)

Injection volume
(ml)

100mg/ml
Solution for Injection
ENOXAPARIN SODIUM
syringes

40

40mg / 0.4ml

40 bd

0.40

45
50
55
60

60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml

45 bd
50 bd
55 bd
60 bd

0.45
0.50
0.55
0.60

65
70
75
80

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

105
110
115
120

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

105 bd
110 bd
115 bd
120 bd

0.70
0.74
0.78
0.80

125
130
135
140
145
150

150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

125 bd
130 bd
135 bd
140 bd
145 bd
150 bd

0.84
0.88
0.90
0.94
0.98
1.00

The name of this medicine is Enoxaparin Sodium Solution for Injection but it will be referred to as
Enoxaparin Sodium throughout this leaflet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
20mg injection

Enoxaparin sodium 20mg (equivalent to 2,000 IU anti-Xa activity) in 0.2mL Water
for Injections
40mg injection
Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4mL Water
for Injections
60mg injection
Enoxaparin sodium 60mg (equivalent to 6,000 IU anti-Xa activity) in 0.6mL Water
for Injections
80mg injection
Enoxaparin sodium 80mg (equivalent to 8,000 IU anti-Xa activity) in 0.8mL Water
for Injections
100mg injection
Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0mL
Water for Injections
For full list of excipients, see section 6.1

150mg/ml
Solution for Injection
ENOXAPARIN SODIUM
Forte syringes

3.
PHARMACEUTICAL FORM
Solution for injection.
Clear solution.
4.2
Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20
mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of
thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery,
the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Enoxaparin Sodium should be administered subcutaneously as a single daily injection of 1.5 mg/kg
(150 IU/kg). Enoxaparin Sodium treatment is usually prescribed for at least 5 days and until adequate
oral anticoagulation is established.

Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only,
followed by 1mg/kg dosing for the remaining doses). For dosage in patients 75 years of age, see
section 4.2 Posology and method of administration: Elderly.

Kg

Syringe label

Dose (mg)

Patient weight

Kg

Syringe label

Dose (mg)

40

60mg / 0.6ml

60 od

100mg/ml
Solution for Injection
ENOXAPARIN SODIUM
syringes

40

40mg / 0.4ml

40 bd

80mg / 0.8ml
80mg / 0.8ml

67.5 od
75 od

45
50
55
60

60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml

45 bd
50 bd
55 bd
60 bd

100mg / 1ml
100mg / 1ml
100mg / 1ml

82.5 od
90 od
97.5 od

0.825
0.90
0.975

70
75
80

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

105 od
112.5 od
120 od

0.70
0.76
0.80

150mg/ml
Solution for Injection
ENOXAPARIN SODIUM
Forte syringes

85
90
95
100

150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

127.5 od
135 od
142.5 od
150 od

0.86
0.90
0.96
1.00

Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Enoxaparin Sodium every 12 hours by subcutaneous injection,
administered concurrently with oral aspirin (100 to 325mg once daily).
Treatment with Enoxaparin Sodium in these patients should be prescribed for a minimum of 2 days
and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days.

Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged 75 years only)
Patient weight

Kg

Syringe label

0.75mg/kg
Dose (mg)

Adjusted
dosing (mg)

Injection
volume (ml)

100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes

40
45
50
55
60
65
70
75
80

60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml

30 bd
33.75 bd
37.5 bd
41.25 bd
45 bd
48.75 bd
52.5 bd
56.25 bd
60 bd

30 bd
35 bd
37.5 bd
42.5 bd
45 bd
50 bd
52.5 bd
57.5 bd
60 bd

0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60

85
90
95
100
105

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml

63.75 bd
67.5 bd
71.25 bd
75 bd
78.75 bd (1)

65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)

0.65
0.675
0.725
0.75
0.80 (1)

110
115
120
125
130

100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

82.5 bd (1)
86.25 bd (1)
90 bd (1)
93.75 bd (1)
97.5 bd (1)

82.5 bd (1)
87.5 bd (1)
90 bd (1)
95 bd (1)
97.5 bd (1)

0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)

135
140
145
150

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

101.25 bd (1)
105 bd (1)
108.75 bd (1)
112.5 bd (1)

102 bd (1)
105 bd (1)
111 bd (1)
114 bd (1)

0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1)

0.45
0.50
0.55
0.60

65
70
75
80

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

105
110
115
120

120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)

105 bd (1)
110 bd (1)
115 bd (1)
120 bd (1)

0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1)

125
130
135
140
145
150

150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)

125 bd (1)
130 bd (1)
135 bd (1)
140 bd (1)
145 bd (1)
150 bd (1)

0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1)

0.675
0.75

55
60
65

Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients 75 years of
age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg
for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is
impaired (see also section 4.2 Posology and method of administration: Renal impairment; section 4.4
Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment, and
Monitoring; section 5.2 Pharmacokinetic properties).

0.40

0.60

45
50

Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis
session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than
normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a
high risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular
access or 0.75 mg/kg (75 IU/kg) for single vascular access.

Injection volume
(ml)

Injection volume
(ml)

100mg/ml
Solution for Injection
ENOXAPARIN SODIUM
syringes

The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
SC administration was given less than 8 hours before balloon inflation, no additional dosing is
needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV
bolus of 0.3mg/kg of enoxaparin sodium should be administered.

Dosage chart for 1mg/kg SC treatment of STEMI

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient weight

When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin
sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic
therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having
STEMI and maintained under (75 to 325mg once daily) unless contraindicated.

150mg/ml
Solution for Injection
ENOXAPARIN SODIUM
Forte syringes

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by
1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.

150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM Forte
syringes

(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by
0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment
and Monitoring; section 5.2 Pharmacokinetic properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30
ml/min), according to the following tables, since enoxaparin sodium exposure is significantly
increased in this patient population:

Dosage adjustments for therapeutic dosage range
Standard dosing

Severe renal impairment

1 mg/kg SC twice daily

1 mg/kg SC once daily

1.5 mg/kg SC once daily

1 mg/kg SC once daily

To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to
use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as
follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete
contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml remaining in the bag. Gently
mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for
administration into the intravenous line (using an appropriate injection site or port).

For treatment of acute STEMI in patients <75 years of age
After dilution is completed, the volume to be injected can be calculated using the following formula
[Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is
recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use.

30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg twice daily.
(Max 100mg for each of the first two SC doses)

30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg once daily.
(Max 100mg for first SC dose only)

For treatment of acute STEMI in elderly patients

75 years of age

Volume to be injected through intravenous line after dilution is completed

0.75mg/kg SC twice daily without initial bolus.
(Max 75mg for each of the first two SC doses)

1mg/kg SC once daily without initial bolus.
(Max 100mg for first SC dose only)

Weight
[Kg]

Required dose
(0.3 mg/kg)
[mg]

Volume to inject when diluted to a final concentration of 3
mg/ml
[ml]

45

13.5

4.5

50

15

5

55

16.5

5.5

60

18

6

The recommended dosage adjustments do not apply to the haemodialysis indication.

65

19.5

6.5

Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment
(creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min),
careful clinical monitoring is advised.

70

21

7

75

22.5

7.5

80

24

8

Hepatic impairment: In the absence of clinical studies, caution should be exercised.

85

25.5

8.5

Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4
Special warnings and precautions for use: Low body weight and Monitoring; section 5.2
Pharmacokinetic properties).

90

27

9

95

28.5

9.5

100

30

10

105

31.5

10.5

110

33

11

115

34.5

11.5

120

36

12

To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic
safety device

125

37.5

12.5

130

39

13

Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Enoxaparin Sodium should be
administered when the patient is lying down by deep subcutaneous injection. The administration
should be alternated between the left and right anterolateral or posterolateral abdominal wall. The
whole length of the needle should be introduced vertically into a skin fold held between the thumb
and index finger. The skin fold should not be released until the injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects the
used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.

135

40.5

13.5

140

42

14

145

43.5

14.5

150

45

15

Dosage adjustments for prophylactic dosage ranges
Standard dosing

Severe renal impairment

40 mg SC once daily

20 mg SC once daily

20 mg SC once daily

20 mg SC once daily

Enoxaparin Sodium is administered by subcutaneous injection for the prevention of venous
thromboembolic disease, treatment of deep vein thrombosis or for the treatment of unstable angina,
non-Q-wave myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the
arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal
circulation during haemodialysis; and via intravenous (bolus) injection through an intravenous line
only for the initial dose of acute STEMI indication and before PCI when needed. It must not be
administered by the intramuscular route.

Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be
used. Enoxaparin sodium should be administered through an intravenous line. It should not be mixed
or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with
all other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or
dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium to
clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution
(0.9%) or 5% dextrose in water.
 Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or
100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The 30mg dose can
then be directly injected into an injection site in the intravenous line.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Water for Injections

6.2

Incompatibilities
Subcutaneous Injection
Enoxaparin Sodium should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in
dextrose in water.

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Enoxaparin Sodium pre-filled syringes are single dose containers – discard any unused
product

6.5

Nature and contents of container
Solution for injection in Type 1 glass pre-filled syringes fitted with injection needle and an
automatic safety device in packs of 10.

6.6

Special precautions for disposal
See section 4.2 Posology and method of administration.



Additional bolus for PCI when last SC administration was given more than 8 hours before
balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of
0.3mg/kg is to be administered if last SC administration was given more than 8 hours before balloon
inflation (see section 4.2 Posology and method of administration: Treatment of acute ST-segment
Elevation Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the
drug to 3mg/ml.

10
DATE OF REVISION OF THE TEXT
11th June 2014

Expand view ⇕

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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