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CLEXANE 80MG-0.8ML SYRINGES

Active substance(s): ENOXAPARIN SODIUM

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Clexane 20mg/0.2ml Syringe/
Clexane 40mg/0.4ml Syringe
(enoxaparin sodium)
Patient Information Leaflet
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/0.2ml Syringe/Clexane
40mg/0.4ml Syringe (called Clexane in this leaflet). 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:
 Unstable angina (where not enough blood gets to your heart)
 After an operation or long periods of bed rest due to illness
 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 an 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)
 Do not inject Clexane into a muscle (intramuscular)
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 for 7 to 10 days. 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 for 7 to 28 days. 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
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
 The maximum amount of Clexane 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 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) Stopping 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.

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.

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

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.
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.
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.
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.
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.
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 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

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 thumb.
This will send the medication into the fatty tissue of the stomach. Make
sure you hold the skin fold throughout the injection

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 Clexane

8) Remove the needle by pulling it straight out. You can now let go of
the skin fold.
To avoid bruising, do not rub the injection site after you have
injected yourself.
9) Drop the used syringe – needle first - 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 too much or too little Clexane
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.
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
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.
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.

 Keep all medicines out of the sight and reach of children.
 Do not store above 25°C. Do not refrigerate or freeze.
 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.
 If the medicine become discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist who will tell you what
to do.
 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
 Each 20mg/0.2ml syringe contains 20mg (2,000 IU anti-Xa activity) of
the active substance, enoxaparin sodium in 0.2ml
 Each 40mg/0.4ml syringe contains 40mg (4,000 IU anti-Xa activity) of
the active substance, enoxaparin sodium in 0.4ml
 The other ingredient is water for injections
What Clexane Pre-filled Syringes looks like and contents of the
pack
Clexane is a Clear, colourless to pale yellow solution, in a Type I glass
prefilled syringe fitted with an injection needle and needle cap.
Clexane 20mg/0.2ml syringe is supplied in packs of 10 syringes.
Clexane 40mg/0.4ml syringe is supplied in packs of 10 syringes.
PL 10383/1977

Clexane 20mg/0.2ml syringe /
Clexane 40mg/0.4ml syringe

POM

This product is manufactured by Sanofi Winthrop Industrie Boulevard
Industriel, zone industrielle 76580 Le Trait, France and is procured from
within the EU and repackaged by the Product License holder:
Primecrown Ltd., 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
Leaflet Date: 20.04.2016

Clexane 60mg/0.6ml Syringe/
Clexane 80mg/0.8ml Syringe
(enoxaparin sodium)
Patient Information Leaflet
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 60mg/0.6ml Syringe/Clexane
80mg/0.8ml Syringe (called Clexane in this leaflet). 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:
 Unstable angina (where not enough blood gets to your heart)
 After an operation or long periods of bed rest due to illness
 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 an 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)
 Do not inject Clexane into a muscle (intramuscular)
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 for 7 to 10 days. 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 for 7 to 28 days. 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
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
 The maximum amount of Clexane 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 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) Stopping 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.

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.

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

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.
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.
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.
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.
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.
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 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

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 thumb.
This will send the medication into the fatty tissue of the stomach. Make
sure you hold the skin fold throughout the injection

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 Clexane

8) Remove the needle by pulling it straight out. You can now let go of
the skin fold.
To avoid bruising, do not rub the injection site after you have
injected yourself.
9) Drop the used syringe – needle first - 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 too much or too little Clexane
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.
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
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.
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.

 Keep all medicines out of the sight and reach of children.
 Do not store above 25°C. Do not refrigerate or freeze.
 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.
 If the medicine become discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist who will tell you what
to do.
 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
 Each 60mg/0.6ml syringe contains 60mg (6,000 IU anti-Xa activity ) of
the active substance, enoxaparin sodium in 0.6ml
 Each 80mg/0.8ml syringe contains 80mg (8,000 IU anti-Xa activity) of
the active substance, enoxaparin sodium in 0.8ml
 The other ingredient is water for injections
What Clexane Pre-filled Syringes looks like and contents of the
pack
Clexane is a Clear, colourless to pale yellow solution, in a Type I glass
prefilled syringe fitted with an injection needle and needle cap.
Clexane 60mg/0.6ml syringe is supplied in packs of 2 and 10 syringes.
Clexane 80mg/0.8ml syringe is supplied in packs of 2 and 10 syringes.
PL 10383/1977

Clexane 60mg/0.6ml syringe /
Clexane 80mg/0.8ml syringe

POM

This product is manufactured by Sanofi Winthrop Industrie 180, Rue
jean Jaures, 94702 Maisons-Alfort, France and is procured from within
the EU and repackaged by the Product License holder: Primecrown Ltd.,
4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5
5QS.
Leaflet Date: 20.04.2016

Clexane 100mg/ml Syringe
(enoxaparin sodium)
Patient Information Leaflet
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 100mg/ml Syringe (called
Clexane in this leaflet). 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:
 Unstable angina (where not enough blood gets to your heart)
 After an operation or long periods of bed rest due to illness
 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 an 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)
 Do not inject Clexane into a muscle (intramuscular)
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 for 7 to 10 days. 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 for 7 to 28 days. 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
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
 The maximum amount of Clexane 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 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) Stopping 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.

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.

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

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.
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.
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.
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.
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.
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 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

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 thumb.
This will send the medication into the fatty tissue of the stomach. Make
sure you hold the skin fold throughout the injection

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 Clexane

8) Remove the needle by pulling it straight out. You can now let go of
the skin fold.
To avoid bruising, do not rub the injection site after you have
injected yourself.
9) Drop the used syringe – needle first – 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 too much or too little Clexane
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.
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
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.
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.

 Keep all medicines out of the sight and reach of children.
 Do not store above 25°C. Do not refrigerate or freeze.
 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.
 If the medicine become discoloured or show signs of any deterioration,
you should seek the advice of your pharmacist who will tell you what
to do.
 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
 Each 100mg/ml syringe contains 100mg (10,000 IU anti-Xa activity) of
the active substance, enoxaparin sodium in 1ml
 The other ingredient is water for injections
What Clexane Pre-filled Syringes looks like and contents of the
pack
Clexane is a Clear, colourless to pale yellow solution, in a Type I glass
prefilled syringe fitted with an injection needle and needle cap.
Clexane 100mg/ml syringe is supplied in packs of 2 and 10 syringes.
PL 10383/1977

Clexane 100mg/ml syringe

POM

This product is manufactured by Chinoin Pharmaceutical and Chemical
Works Private Co. Ltd. Csanyikvolgy Site, Miszkolc, Csanyikvolgy 3510
Hungary and is procured from within the EU and repackaged by the
Product License holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet Date: 20.04.2016
Clexane is a registered trademark of Aventis Pharma SA, France.

Clexane 20mg/0.2ml Syringe/
Clexane 40mg/0.4ml Syringe/
Clexane 60mg/0.6ml Syringe/
Clexane 80mg/0.8ml Syringe/
Clexane 100mg/ml Syringe
(enoxaparin sodium)
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes

1) NAME OF THE MEDICINAL PRODUCT
Clexane Syringes

2) QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
20 mg Injection Enoxaparin sodium 20 mg (equivalent to 2,000 IU antiXa activity) in 0.2 mL Water for Injections
40 mg Injection Enoxaparin sodium 40 mg (equivalent to 4,000 IU antiXa activity) in 0.4 mL Water for Injections
60 mg Injection Enoxaparin sodium 60 mg (equivalent to 6,000 IU antiXa activity) in 0.6 mL Water for Injections
80 mg Injection Enoxaparin sodium 80 mg (equivalent to 8,000 IU antiXa activity) in 0.8 mL Water for Injections
100 mg Injection Enoxaparin sodium 100mg (equivalent to 10,000 IU
anti-Xa activity) in 1.0 mL Water for Injections
For full list of excipients, see section 6.1

3) PHARMACEUTICAL FORM
Solution for injection. Clear, colourless to pale yellow 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.
In patients with a high-risk of venous thromboembolism who undergo
abdominal or pelvic surgery for cancer and are not otherwise at risk for
major bleeding complications, the recommended dosage is 40 mg
(4,000 IU) once daily by subcutaneous injection for 4 weeks 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.
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
Kg
Syringe label
Dose (mg)
Injection
weight
volume (ml)
100mg/ml
40
60mg / 0.6ml
60 od
0.60
Solution for
Injection
45
0.675
80mg / 0.8ml
67.5 od
CLEXANE
50
0.75
80mg / 0.8ml
75 od
syringes
55
0.825
100mg / 1ml
82.5 od
60
90 od
0.90
100mg / 1ml
97.5 od
65
0.975
100mg / 1ml
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
Kg
Syringe label
Dose (mg)
Injection
weight
volume (ml)
150mg/ml
70
105 od
0.70
120mg / 0.8ml
Solution for
75
120mg / 0.8ml
112.5 od
0.76
Injection
120 od
80
120mg / 0.8ml
0.80
CLEXANE
Forte
85
0.86
150mg / 1ml
127.5 od
syringes
90
150mg / 1ml
135 od
0.90
95
0.96
150mg / 1ml
142.5 od
100
1.00
150mg / 1ml
150 od
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 1mg/kg SC treatment of UA or NSTEMI
Patient
Kg
Syringe label
Dose (mg)
weight
100mg/ml
40
40mg / 0.4ml
40 bd
Solution for
Injection
45
45 bd
60mg / 0.6ml
CLEXANE
50
50 bd
60mg / 0.6ml
syringes
55
55 bd
60mg / 0.6ml
60
60 bd
60mg / 0.6ml
65
65 bd
80mg / 0.8ml
70
70 bd
80mg / 0.8ml
75
75 bd
80mg / 0.8ml
80
80mg / 0.8ml
80 bd
85
85 bd
100mg / 1ml
90
90 bd
100mg / 1ml
95
95 bd
100mg / 1ml
100
100mg / 1ml
100 bd

Injection
volume (ml)
0.40
0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
Kg
Syringe label
Dose (mg)
Injection
weight
volume (ml)
150mg/ml
105
105 bd
0.70
120mg / 0.8ml
Solution for
110
110 bd
0.74
120mg / 0.8ml
Injection
115
115 bd
0.78
120mg / 0.8ml
Clexane
120
120 bd
0.80
120mg / 0.8ml
Forte
125
125 bd
0.84
150mg / 1ml
syringes
130
150mg / 1ml
130 bd
0.88
135
135 bd
0.90
150mg / 1ml
140
140 bd
0.94
150mg / 1ml
145
150mg / 1ml
145 bd
0.98
150
150mg / 1ml
150 bd
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 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.
Dosage chart for 1mg/kg SC treatment of STEMI
Patient
Kg
Syringe label
Dose (mg)
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes

40

40mg / 0.4ml

40 bd

Injection
volume
(ml)
0.40

45
50
55
60
65
70
75
80
85
90
95
100

60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

45 bd
50 bd
55 bd
60 bd
65 bd
70 bd
75 bd
80 bd
85 bd
90 bd
95 bd
100 bd

0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00

Dosage chart for 1mg/kg SC treatment of STEMI
Patient
Kg
Syringe label
Dose (mg)
weight
150mg/ml
Solution
for
Injection
CLEXANE
Forte
syringes

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)

Injection
volume
(ml)
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)

(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.
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.
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.
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.
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).

Dosage chart for 0.75mg/kg SC treatment of STEMI (elderly patients aged
≥75 years only)
Patient
Kg
Syringe
0.75mg/kg
Adjusted
Injection
weight
label
Dose (mg)
dosing
volume
(mg)
(ml)
100mg/ml
40 60mg / 0.6ml
30 bd
30 bd
0.30
Solution
45 60mg / 0.6ml
33.75 bd
35 bd
0.35
50 60mg / 0.6ml
37.5 bd
37.5 bd
0.375
for
55 60mg / 0.6ml
42.5 bd
0.425
Injection
41.25 bd
45 bd
0.45
45 bd
CLEXANE 60 60mg / 0.6ml
50 bd
65 60mg / 0.6ml
0.5
48.75 bd
syringes
52.5 bd
70 60mg / 0.6ml
0.525
52.5 bd
57.5 bd
75 60mg / 0.6ml
0.575
56.25 bd
80 60mg / 0.6ml
60 bd
0.60
60 bd

150mg/ml
Solution
for
Injection

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)

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.

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.
• 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.
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).
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.
Volume to be injected through intravenous line after dilution is
completed

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
Pharmacokinetic properties).

5.2

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
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a
30mg-single IV bolus plus a
1mg/kg SC dose followed by
1mg/kg SC dose followed by
1mg/kg twice daily. (Max 100mg
1mg/kg once daily. (Max 100mg
for each of the first two SC doses)
for first SC dose only)
For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without
1mg/kg SC once daily without
initial bolus. (Max 75mg for each
initial bolus. (Max 100mg for first
of the first two SC doses)
SC dose only)
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
The recommended dosage
haemodialysis indication.

adjustments

do

not

apply

to

the

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.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4
Special warnings and precautions for use: Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be
exercised.
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).
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.
To avoid accidental needle stick after injection, the prefilled syringes are
fitted with an automatic safety device.
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.
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 coadministered with other medications. To avoid the possible mixture of

Weight

Required
dose
(0.3mg/kg)

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

Weight

Required
dose
(0.3mg/kg)

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

(Kg)

(mg)

(ml)

(Kg)

(mg)

(ml)

45

13.5

4.5

100

30

10

50

15

5

105

31.5

10.5

55

16.5

5.5

110

33

11

60

18

6

115

34.5

11.5

65

19.5

6.5

120

36

12

70

21

7

125

37.5

12.5

75

22.5

7.5

130

39

13

80

24

8

135

40.5

13.5

85

25.5

8.5

140

42

14

90

27

9

145

43.5

14.5

95

28.5

9.5

150

45

15

6 PHARMACEUTICAL PARTICULARS
6.1 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 I glass pre-filled syringes fitted with
injection needle and an automatic safety device in packs of 2, 10 and
20.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
7. Product Licence holder
Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt,
Middlesex, UB5 5QS.
8. Product Licence holder number

PL 10383/1977

9. Legal Status

POM

10. Date of revision of the text

20.04.2016

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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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