PACKAGE LEAFLET: INFORMATION FOR THE USER Operations and anaesthetics

Clexane® 20mg/0.2ml Syringes/ Clexane® 40mg/0.4ml Syringes/

If you are going to have a spinal puncture or an operation where an epidural or spinal
Clexane® 80mg/0.8ml Syringes/ Clexane® 100mg/1ml Syringes anaesthetic is used, tell your doctor that you are using Clexane. Tell also your doctor if you
(enoxaparin sodium) have any problem with your spine or if you have ever had spinal surgery.
This product is available as any of the above names but will be referred to as Clexane Pregnancy and breast-feeding
throughout the following leaflet. Please note that the leaflet also contains information
about another strength (Clexane 60mg/0.6ml Syringes). Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
Read all of this leaflet carefully before you start using this medicine
■ Keep this leaflet. You may need to read it again You should not use this medicine if you are pregnant and have a mechanical heart valve as
■ If you have any further questions, ask your doctor or pharmacist you may be at increased risk of developing blood clots. Your doctor should discuss this with
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm you.
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 You should not breast-feed whilst using Clexane. If you are planning to breast-feed, talk to
leaflet, please tell your doctor or pharmacist your doctor, pharmacist or nurse.
In this leaflet: Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.
1. What Clexane is and what it is used for
2. Before you use Clexane 3. How to use Clexane
3. How to use Clexane
4. Possible side-effects Having this medicine
5. How to store Clexane
6. Further information ■ 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
1. What Clexane is and what it is used for 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
Clexane contains a medicine called enoxaparin sodium. This belongs to a group of (see below instructions on how to do this)
medicines called Low Molecular Weight Heparins. ■ Clexane is usually given by injection underneath the skin (subcutaneous)
Clexane works in two ways. If you are not sure why you are receiving Clexane or have any questions about how much
1) Stopping existing blood clots from getting any bigger. This helps your body to break Clexane is being given to you, speak to your doctor, pharmacist or nurse.
them down and stop them causing you harm.
2) Stopping blood clots forming in your blood. How much will be given to you
Clexane can be used to: ■ Your doctor will decide how much to give you. The amount of Clexane given to you will
■ Treat blood clots that are in your blood
depend on the reason it is being used
■ Stop blood clots forming in your blood in the following situations:
■ If you have problems with your kidneys, you may be given a smaller amount of Clexane
■ Unstable angina (where not enough blood gets to your heart)
■ After an operation or long periods of bed rest due to illness
1) Treating blood clots that are in your blood
■ After you have had a heart attack
■ The usual dose is 1.5mg for every kilogram of your weight, each day
■ Stop blood clots forming in the tubes of your dialysis machine (used for people with
■ Clexane will usually be given for at least 5 days
kidney problems)
2) Stopping blood clots forming in your blood in the following situations:
2. Before you use Clexane
a) Unstable angina
Do not have this medicine and tell your doctor, pharmacist or nurse if: ■ 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
■ You are allergic (hypersensitive) to enoxaparin sodium or any of the other ingredients of
aspirin as well
Clexane (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
b) After an operation or long periods of bedrest due to illness
of your lips, face, throat or tongue
The usual dose is 20mg or 40mg each day. The dose will depend on how likely you
■ You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin
are to develop a clot
or dalteparin
■ If you have a low to medium risk of getting a clot, you will be given 20mg of Clexane
■ You have a problem with bruising or bleeding too easily
each day. If you are going to have an operation, your first injection will usually be
■ You have an ulcer in your stomach or gut (intestine)
given 2 hours before your operation
■ You have had a stroke caused by bleeding in the brain
■ If you have a higher risk of getting a clot, you will be given 40mg each day. If you are
■ You have an infection in your heart
going to have an operation, your first injection will usually be given 12 hours before
■ You are using the medicine called heparin to treat blood clots
your operation
■ If you are bedridden due to illness, you will be normally be given 40mg of Clexane
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your
each day for 6 to 14 days
doctor, pharmacist or nurse before having Clexane.
c) After you have had a heart attack
Take special care with Clexane
Clexane can be used for two different types of heart attack called NSTEMI or STEMI.
Check with your doctor or pharmacist or nurse before using this medicine if: The amount of Clexane given to you will depend on your age and the kind of heart
attack you have had.
■ You have high blood pressure
■ You have kidney problems i) NSTEMI type of heart attack
■ You have had a heart valve fitted ■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ You have ever had bruising and bleeding caused by the medicine ‘heparin’ ■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
■ You have ever had a stroke aspirin as well
■ You have ever had a stomach ulcer
■ You have recently had an operation on your eyes or brain ii) STEMI type of heart attack
■ You are a diabetic or have a illness known as ‘diabetic retinopathy’ (problems with the If you are under 75 years old
blood vessels in the eye caused by diabetes) ■ 30mg of Clexane will be given as an injection into your vein (intravenous injection
■ You have any problems with your blood using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ You are underweight or overweight ■ At the same time, you will also be given Clexane as an injection under your skin
■ You are elderly (over 65 years old) and especially if you are aged over 75 years old (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
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or that
nurse before using Clexane. ■ The maximum amount of Clexane given for the first two injections is 100mg
■ The injections will normally be given for up to 8 days
Taking or using other medicines
If you are aged 75 years or older
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any ■ Your doctor or nurse will give you injections of Clexane under your skin
other medicines. This includes medicines you buy without a prescription, including herbal (subcutaneous injection)
medicines. This is because Clexane can affect the way some other medicines work. Also ■ The usual dose is 0.75mg for every kilogram of your weight, every 12 hours
some medicines can affect the way Clexane works. ■ The maximum amount of Clexane given for the first two injections is 75mg

In particular, do not have this medicine and tell your doctor if: For patients having an operation called Percutaneous Coronary Intervention (PCI)
■ You are using the medicine called heparin to treat blood clots ■ 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
Tell your doctor if you are taking any of the following medicines: (intravenous using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ Warfarin - used for thinning the blood
■ Aspirin, dipyridamole, clopidogrel or other medicines - used to stop blood clots forming 3) Stop blood clots forming in the tubes of your dialysis machine
■ Dextran injection - used as a blood replacer ■ The usual dose is 1 mg for every kilogram of your weight
■ Ibuprofen, diclofenac, ketorolac or other medicines - used to treat pain and swelling in ■ Clexane is added to the tube leaving the body (arterial line) at the start of the dialysis
arthritis and other illnesses session
■ Prednisolone, dexamethasone or other medicines - used to treat asthma, rheumatoid ■ This amount is usually enough for a 4 hour session. However, your doctor may give
arthritis and other conditions you a further dose of 0.5 to 1mg for every kilogram of your weight if necessary
■ Water tablets (diuretics) such as spironolactone, triamterene or amiloride. These may
increase the levels of potassium in your blood when taken with Clexane How to give yourself an injection of Clexane

Your doctor may change one of your medicines or take regular blood tests to check that If you are able to give Clexane to yourself, your doctor or nurse will show you how to do
taking these medicines with Clexane is not causing you any harm. 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 Blood Tests

■ Check the expiry date on the medicine. Do not use if the date has passed Using Clexane may affect the results of some blood tests. If you are going to have a blood
■ Check the syringe is not damaged and the medicine in it is a clear solution. If not, use test, it is important to tell your doctor you are having Clexane.
another syringe
■ Make sure you know how much you are going to inject 4. Possible side-effects
■ 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 Like all medicines, Clexane can cause side-effects, although not everybody gets them.
■ 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 Tell a nurse or doctor or go to hospital straight away if you notice any of the
under the skin on your stomach, but not too near the belly button or any scar tissue (at following side-effects:
least 5 cm away from these)
Very common (affects more than 1 in 10 people)
Instructions on injecting yourself with Clexane: ■ Bleeding a lot from a wound.

1) Wash your hands and the area that you will inject with soap and water. Dry them. 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
2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place your stomach.
you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
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.
■ 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
3) Choose an area on the right or left side of your stomach. This should be at least 5 effects:
centimetres away from your belly button and out towards your sides. Common (affects 1 to 10 people in a 100)
■ You bruise more easily than usual. This could be because of a blood problem
Remember: Do not inject yourself within 5 centimetres of your belly button or around (thrombocytopenia).
existing scars or bruises. Change the place where you inject between the left and right ■ You have pain, swelling or irritation in the area you have been injected with Clexane.
sides of your stomach, depending on the area you were last injected. This normally gets better after a few days.

4) Carefully pull off the needle cap from the Clexane syringe. Throw away the cap. The Rare (affects less than 1 in a 1000 people)
syringe is pre-filled and ready to use. ■ 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

Other side effects that you should discuss with your nurse or doctor if you are
concerned about them:
Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead Very common (affects more than 1 in 10 people)
to a loss of the medicine. Once you have removed the cap, do not allow the needle to touch ■ Changes in the results of blood tests done to check how your liver is working. These
anything. This is to make sure the needle stays clean (sterile). usually go back to normal after you stop having Clexane.

5) Hold the syringe in the hand you write with (like a pencil) and with your other hand, Rare (affects less than 1 in a 1000 people)
gently pinch the cleaned area of your abdomen between your forefinger and thumb to ■ Changes in the potassium levels in your blood. This is more likely to happen in people
make a fold in the skin. 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, it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones are more likely to break

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Make sure you hold the skin fold throughout the injection. possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: [Link]/yellowcard
6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle). By reporting side effects you can help provide more information on the safety of this
Insert the full length of the needle into the skin fold. medicine.

7) Press down on the plunger with your finger. 5. How to store and dispose of Clexane
This will send the medication into the fatty tissue of the stomach. Make sure you hold the
skin fold throughout the injection. ■ Keep out of the sight and reach of children.
■ Do not use Clexane after the expiry date, which is stated on the carton.
■ Do not store above 25°C. Do not refrigerate or freeze.
■ If this medicine becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist.
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.

8) Remove the needle by pulling it straight out. 6. Further Information

You can now let go of the skin fold.
To avoid bruising, do not rub the injection site after you have injected yourself. What Clexane contains

9) Drop the used syringe - the needle end first - into the sharps bin provided. Close the ■ Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
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. ■ Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.4ml
Do not put it in the household rubbish.
■ Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.8ml
If you have more Clexane than you should
■ Each 100mg pre-filled syringe contains 100mg (10,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 1ml
If you think that you have used too much or too little Clexane, tell your doctor, nurse or
■ The other ingredient is water for injections
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. What Clexane Syringes looks like and contents of the pack
If you forget to use Clexane Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s
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 POM PL No: 15814/1002
will help to make sure you do not miss a dose.
The Manufacturer is Sanofi Winthrop Industrie, Boulevard Industrial, Le Trait, F-76580
If you stop using Clexane France and procured from within the EU by the Product Licence Holder and repackaged by
OPD Laboratories Limited, Colonial Way, Watford, Herts WD24 4PR.
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. 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.

Leaflet revision and issue date (Ref.) 09.09.2013.

The registered Trademark holder for Clexane is Sanofi-Aventis.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
 PACKAGE LEAFLET: INFORMATION FOR THE USER Operations and anaesthetics
Clexane® 20mg/0.2ml Syringes/ Clexane® 40mg/0.4ml Syringes/
If you are going to have a spinal puncture or an operation where an epidural or spinal
Clexane® 80mg/0.8ml Syringes/ Clexane® 100mg/1ml Syringes anaesthetic is used, tell your doctor that you are using Clexane. Tell also your doctor if you
(enoxaparin sodium) have any problem with your spine or if you have ever had spinal surgery.
This product is available as any of the above names but will be referred to as Clexane Pregnancy and breast-feeding
throughout the following leaflet. Please note that the leaflet also contains information
about another strength (Clexane 60mg/0.6ml Syringes). Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
Read all of this leaflet carefully before you start using this medicine
■ Keep this leaflet. You may need to read it again You should not use this medicine if you are pregnant and have a mechanical heart valve as
■ If you have any further questions, ask your doctor or pharmacist you may be at increased risk of developing blood clots. Your doctor should discuss this with
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm you.
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 You should not breast-feed whilst using Clexane. If you are planning to breast-feed, talk to
leaflet, please tell your doctor or pharmacist your doctor, pharmacist or nurse.
In this leaflet: Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.
1. What Clexane is and what it is used for
2. Before you use Clexane 3. How to use Clexane
3. How to use Clexane
4. Possible side-effects Having this medicine
5. How to store Clexane
6. Further information ■ 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
1. What Clexane is and what it is used for 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
Clexane contains a medicine called enoxaparin sodium. This belongs to a group of (see below instructions on how to do this)
medicines called Low Molecular Weight Heparins. ■ Clexane is usually given by injection underneath the skin (subcutaneous)
Clexane works in two ways. If you are not sure why you are receiving Clexane or have any questions about how much
1) Stopping existing blood clots from getting any bigger. This helps your body to break Clexane is being given to you, speak to your doctor, pharmacist or nurse.
them down and stop them causing you harm.
2) Stopping blood clots forming in your blood. How much will be given to you
Clexane can be used to: ■ Your doctor will decide how much to give you. The amount of Clexane given to you will
■ Treat blood clots that are in your blood
depend on the reason it is being used
■ Stop blood clots forming in your blood in the following situations:
■ If you have problems with your kidneys, you may be given a smaller amount of Clexane
■ Unstable angina (where not enough blood gets to your heart)
■ After an operation or long periods of bed rest due to illness
1) Treating blood clots that are in your blood
■ After you have had a heart attack
■ The usual dose is 1.5mg for every kilogram of your weight, each day
■ Stop blood clots forming in the tubes of your dialysis machine (used for people with
■ Clexane will usually be given for at least 5 days
kidney problems)
2) Stopping blood clots forming in your blood in the following situations:
2. Before you use Clexane
a) Unstable angina
Do not have this medicine and tell your doctor, pharmacist or nurse if: ■ 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
■ You are allergic (hypersensitive) to enoxaparin sodium or any of the other ingredients of
aspirin as well
Clexane (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
b) After an operation or long periods of bedrest due to illness
of your lips, face, throat or tongue
The usual dose is 20mg or 40mg each day. The dose will depend on how likely you
■ You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin
are to develop a clot
or dalteparin
■ If you have a low to medium risk of getting a clot, you will be given 20mg of Clexane
■ You have a problem with bruising or bleeding too easily
each day. If you are going to have an operation, your first injection will usually be
■ You have an ulcer in your stomach or gut (intestine)
given 2 hours before your operation
■ You have had a stroke caused by bleeding in the brain
■ If you have a higher risk of getting a clot, you will be given 40mg each day. If you are
■ You have an infection in your heart
going to have an operation, your first injection will usually be given 12 hours before
■ You are using the medicine called heparin to treat blood clots
your operation
■ If you are bedridden due to illness, you will be normally be given 40mg of Clexane
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your
each day for 6 to 14 days
doctor, pharmacist or nurse before having Clexane.
c) After you have had a heart attack
Take special care with Clexane
Clexane can be used for two different types of heart attack called NSTEMI or STEMI.
Check with your doctor or pharmacist or nurse before using this medicine if: The amount of Clexane given to you will depend on your age and the kind of heart
attack you have had.
■ You have high blood pressure
■ You have kidney problems i) NSTEMI type of heart attack
■ You have had a heart valve fitted ■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ You have ever had bruising and bleeding caused by the medicine ‘heparin’ ■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
■ You have ever had a stroke aspirin as well
■ You have ever had a stomach ulcer
■ You have recently had an operation on your eyes or brain ii) STEMI type of heart attack
■ You are a diabetic or have a illness known as ‘diabetic retinopathy’ (problems with the If you are under 75 years old
blood vessels in the eye caused by diabetes) ■ 30mg of Clexane will be given as an injection into your vein (intravenous injection
■ You have any problems with your blood using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ You are underweight or overweight ■ At the same time, you will also be given Clexane as an injection under your skin
■ You are elderly (over 65 years old) and especially if you are aged over 75 years old (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
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or that
nurse before using Clexane. ■ The maximum amount of Clexane given for the first two injections is 100mg
■ The injections will normally be given for up to 8 days
Taking or using other medicines
If you are aged 75 years or older
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any ■ Your doctor or nurse will give you injections of Clexane under your skin
other medicines. This includes medicines you buy without a prescription, including herbal (subcutaneous injection)
medicines. This is because Clexane can affect the way some other medicines work. Also ■ The usual dose is 0.75mg for every kilogram of your weight, every 12 hours
some medicines can affect the way Clexane works. ■ The maximum amount of Clexane given for the first two injections is 75mg

In particular, do not have this medicine and tell your doctor if: For patients having an operation called Percutaneous Coronary Intervention (PCI)
■ You are using the medicine called heparin to treat blood clots ■ 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
Tell your doctor if you are taking any of the following medicines: (intravenous using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ Warfarin - used for thinning the blood
■ Aspirin, dipyridamole, clopidogrel or other medicines - used to stop blood clots forming 3) Stop blood clots forming in the tubes of your dialysis machine
■ Dextran injection - used as a blood replacer ■ The usual dose is 1 mg for every kilogram of your weight
■ Ibuprofen, diclofenac, ketorolac or other medicines - used to treat pain and swelling in ■ Clexane is added to the tube leaving the body (arterial line) at the start of the dialysis
arthritis and other illnesses session
■ Prednisolone, dexamethasone or other medicines - used to treat asthma, rheumatoid ■ This amount is usually enough for a 4 hour session. However, your doctor may give
arthritis and other conditions you a further dose of 0.5 to 1mg for every kilogram of your weight if necessary
■ Water tablets (diuretics) such as spironolactone, triamterene or amiloride. These may
increase the levels of potassium in your blood when taken with Clexane How to give yourself an injection of Clexane

Your doctor may change one of your medicines or take regular blood tests to check that If you are able to give Clexane to yourself, your doctor or nurse will show you how to do
taking these medicines with Clexane is not causing you any harm. 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 Blood Tests

■ Check the expiry date on the medicine. Do not use if the date has passed Using Clexane may affect the results of some blood tests. If you are going to have a blood
■ Check the syringe is not damaged and the medicine in it is a clear solution. If not, use test, it is important to tell your doctor you are having Clexane.
another syringe
■ Make sure you know how much you are going to inject 4. Possible side-effects
■ 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 Like all medicines, Clexane can cause side-effects, although not everybody gets them.
■ 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 Tell a nurse or doctor or go to hospital straight away if you notice any of the
under the skin on your stomach, but not too near the belly button or any scar tissue (at following side-effects:
least 5 cm away from these)
Very common (affects more than 1 in 10 people)
Instructions on injecting yourself with Clexane: ■ Bleeding a lot from a wound.

1) Wash your hands and the area that you will inject with soap and water. Dry them. 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
2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place your stomach.
you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
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.
■ 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
3) Choose an area on the right or left side of your stomach. This should be at least 5 effects:
centimetres away from your belly button and out towards your sides. Common (affects 1 to 10 people in a 100)
■ You bruise more easily than usual. This could be because of a blood problem
Remember: Do not inject yourself within 5 centimetres of your belly button or around (thrombocytopenia).
existing scars or bruises. Change the place where you inject between the left and right ■ You have pain, swelling or irritation in the area you have been injected with Clexane.
sides of your stomach, depending on the area you were last injected. This normally gets better after a few days.

4) Carefully pull off the needle cap from the Clexane syringe. Throw away the cap. The Rare (affects less than 1 in a 1000 people)
syringe is pre-filled and ready to use. ■ 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

Other side effects that you should discuss with your nurse or doctor if you are
concerned about them:
Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead Very common (affects more than 1 in 10 people)
to a loss of the medicine. Once you have removed the cap, do not allow the needle to touch ■ Changes in the results of blood tests done to check how your liver is working. These
anything. This is to make sure the needle stays clean (sterile). usually go back to normal after you stop having Clexane.

5) Hold the syringe in the hand you write with (like a pencil) and with your other hand, Rare (affects less than 1 in a 1000 people)
gently pinch the cleaned area of your abdomen between your forefinger and thumb to ■ Changes in the potassium levels in your blood. This is more likely to happen in people
make a fold in the skin. 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, it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones are more likely to break

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
Make sure you hold the skin fold throughout the injection. possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: [Link]/yellowcard
6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle). By reporting side effects you can help provide more information on the safety of this
Insert the full length of the needle into the skin fold. medicine.

7) Press down on the plunger with your finger. 5. How to store and dispose of Clexane
This will send the medication into the fatty tissue of the stomach. Make sure you hold the
skin fold throughout the injection. ■ Keep out of the sight and reach of children.
■ Do not use Clexane after the expiry date, which is stated on the carton.
■ Do not store above 25°C. Do not refrigerate or freeze.
■ If this medicine becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist.
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.

8) Remove the needle by pulling it straight out. 6. Further Information

You can now let go of the skin fold.
To avoid bruising, do not rub the injection site after you have injected yourself. What Clexane contains

9) Drop the used syringe - the needle end first - into the sharps bin provided. Close the ■ Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
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. ■ Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.4ml
Do not put it in the household rubbish.
■ Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.8ml
If you have more Clexane than you should
■ Each 100mg pre-filled syringe contains 100mg (10,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 1ml
If you think that you have used too much or too little Clexane, tell your doctor, nurse or
■ The other ingredient is water for injections
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. What Clexane Syringes looks like and contents of the pack
If you forget to use Clexane Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s
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 POM PL No: 15814/1002
will help to make sure you do not miss a dose.
The Manufacturer is Aventis Pharma Le Trait, Boulevard Industrial, Le Trait, F-76580
If you stop using Clexane France and procured from within the EU by the Product Licence Holder and repackaged by
OPD Laboratories Limited, Colonial Way, Watford, Herts WD24 4PR.
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. 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.

Leaflet revision and issue date (Ref.) 09.09.2013.

The registered Trademark holder for Clexane is Sanofi-Aventis.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
® ®
Clexane 20mg/0.2ml Syringes/ Clexane 40mg/0.4ml Syringes Patient weight Kg Syringe label Dose (mg)
Injection
volume (ml)
Clexane® 60mg/0.6ml Syringes/ Clexane® 80mg/0.8ml Syringes 105 120mg / 0.8ml 105 bd 0.70
Clexane® 100mg/1ml Syringes 110 120mg / 0.8ml 110 bd 0.74
(enoxaparin sodium) 115 120mg / 0.8ml 115 bd 0.78
150mg/ml
The following information is extracted from the SPC 120 120mg / 0.8ml 120 bd 0.80
Solution for
Technical information for the administration of Clexane Syringes 125 150mg / 1ml 125 bd 0.84
Injection
130 150mg / 1ml 130 bd 0.88
Clexane
1. NAME OF THE MEDICINAL PRODUCT Forte syringes 135 150mg / 1ml 135 bd 0.90
This product is available using any of the above names but will be referred to as Clexane 140 150mg / 1ml 140 bd 0.94
throughout the following leaflet. 145 150mg / 1ml 145 bd 0.98
150 150mg / 1ml 150 bd 1.00
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes: Please be aware that in some cases it is not possible to achieve an exact dose due to the
Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of the active graduations on the syringe and so some of the volumes recommended in this table have
substance, enoxaparin sodium, in 0.2ml been rounded up to the nearest graduation.
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.4ml Treatment of acute ST-segment Elevation Myocardial Infarction
Each 60mg pre-filled syringe contains 60mg (6000 IU anti-Xa activity) of the active The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg
substance, enoxaparin sodium, in 0.6ml SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of the active doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients
substance, enoxaparin sodium, in 0.8ml ≥75 years of age, see section 4.2 Posology and method of administration: Elderly.
Each 100mg pre-filled syringe contains 100mg (10000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 1ml Dosage chart for 1mg/kg SC treatment of STEMI
Injection
Patient weight Kg Syringe label Dose (mg)
For full list of excipients, see section 6.1 volume (ml)
40 40mg / 0.4ml 40 bd 0.40
3. PHARMACEUTICAL FORM 45 60mg / 0.6ml 45 bd 0.45
Solution for injection. 50 60mg / 0.6ml 50 bd 0.50
Clear, colourless solution. 55 60mg / 0.6ml 55 bd 0.55
100mg/ml 60 60mg / 0.6ml 60 bd 0.60
4.2 Posology and method of administration Solution for 65 80mg / 0.8ml 65 bd 0.65
Adults: Injection 70 80mg / 0.8ml 70 bd 0.70
Clexane 75 80mg / 0.8ml 75 bd 0.75
Prophylaxis of venous thromboembolism: syringes 80 80mg / 0.8ml 80 bd 0.80
In patients with a low to moderate risk of venous thromboembolism the recommended
85 100mg / 1ml 85 bd 0.85
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 90 100mg / 1ml 90 bd 0.90
should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as 95 100mg / 1ml 95 bd 0.95
in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous 100 100mg / 1ml 100 bd 1.00
injection with the initial dose administered approximately 12 hours before surgery.
Dosage chart for 1mg/kg SC treatment of STEMI
Prophylaxis of venous thromboembolism in medical patients: Injection
Patient weight Kg Syringe label Dose (mg)
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by volume (ml)
subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of 105 120mg / 0.8ml (1) 105 bd (1) 0.70 (1)
6 days and continued until the return to full ambulation, for a maximum of 14 days. 110 120mg / 0.8ml (1) 110 bd (1) 0.74 (1)
115 120mg / 0.8ml (1) 115 bd (1) 0.78 (1)
Treatment of venous thromboembolism: 150mg/ml 120 120mg / 0.8ml (1) 120 bd (1) 0.80 (1)
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg Solution for
125 150mg / 1ml (1) 125 bd (1) 0.84 (1)
(150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until adequate Injection
130 150mg / 1ml (1) 130 bd (1) 0.88 (1)
oral anticoagulation is established. Clexane
Forte syringes 135 150mg / 1ml (1) 135 bd (1) 0.90 (1)
140 150mg / 1ml (1) 140 bd (1) 0.94 (1)
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both 145 150mg / 1ml (1) 145 bd (1) 0.98 (1)
Injection 150 150mg / 1ml (1) 150 bd (1) 1.00 (1)
Patient weight Kg Syringe label Dose (mg)
volume (ml)
40 60mg / 0.6ml 60 od 0.60 (1) Not to be given for the first two doses - (maximum 100mg for the first two doses only,
100mg/ml 45 80mg / 0.8ml 67.5 od 0.675 followed by 1mg/kg dosing for the remaining doses)
Solution for 50 80mg / 0.8ml 75 od 0.75 Please be aware that in some cases it is not possible to achieve an exact dose due to the
Injection graduations on the syringe and so some of the volumes recommended in this table have
Clexane 55 100mg / 1ml 82.5 od 0.825
been rounded up to the nearest graduation.
syringes 60 100mg / 1ml 90 od 0.90
65 100mg / 1ml 97.5 od 0.975 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
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as
Injection they are identified as having STEMI and maintained under (75 to 325mg once daily) unless
Patient weight Kg Syringe label Dose (mg)
volume (ml) contraindicated.
70 120mg / 0.8ml 105 od 0.70
150mg/ml 75 120mg / 0.8ml 112.5 od 0.76 The recommended duration of enoxaparin sodium treatment is 8 days or until hospital
Solution for 80 120mg / 0.8ml 120 od 0.80 discharge, whichever comes first.
Injection 85 150mg / 1ml 127.5 od 0.86
Clexane 90 150mg / 1ml 135 od 0.90 For patients managed with Percutaneous Coronary Intervention (PCI): If the last
Forte syringes 95 150mg / 1ml 142.5 od 0.96 enoxaparin sodium SC administration was given less than 8 hours before balloon inflation,
100 150mg / 1ml 150 od 1.00 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
Please be aware that in some cases it is not possible to achieve an exact dose due to the administered.
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation. 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
Treatment of unstable angina and non-Q-wave myocardial infarction a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as
The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, after a longer than normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may
administered concurrently with oral aspirin (100 to 325mg once daily). be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5
Treatment with Clexane in these patients should be prescribed for a minimum of 2 days mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular
and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days. access.

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI Elderly:

Injection For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75
Patient weight Kg Syringe label Dose (mg) years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12
volume (ml)
40 40mg / 0.4ml 40 bd 0.40 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the
45 60mg / 0.6ml 45 bd 0.45 remaining doses).
50 60mg / 0.6ml 50 bd 0.50
For other indications, no dosage adjustments are necessary in the elderly, unless kidney
55 60mg / 0.6ml 55 bd 0.55
function is impaired (see also section 4.2 Posology and method of administration: Renal
100mg/ml 60 60mg / 0.6ml 60 bd 0.60 impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the
Solution for 65 80mg / 0.8ml 65 bd 0.65 elderly; Renal impairment, and Monitoring; section 5.2 Pharmacokinetic properties).
Injection 70 80mg / 0.8ml 70 bd 0.70
Clexane 75 80mg / 0.8ml 75 bd 0.75
syringes 80 80mg / 0.8ml 80 bd 0.80
85 100mg / 1ml 85 bd 0.85
90 100mg / 1ml 90 bd 0.90
95 100mg / 1ml 95 bd 0.95
100 100mg / 1ml 100 bd 1.00
 Dosage chart for 0.75mg/kg SC treatment of STEMI • Initial 30mg bolus
(elderly patients aged >75 years only) For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80
Adjusted Injection or 100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The
0.75mg/kg 30mg dose can then be directly injected into an injection site in the intravenous line.
Patient weight Kg Syringe label dosing volume
Dose (mg)
(mg) (ml)
40 60mg / 0.6ml 30 bd 30 bd 0.30 • Additional bolus for PCI when last SC administration was given more than 8 hours
45 60mg / 0.6ml 33.75 bd 35 bd 0.35 before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional
50 60mg / 0.6ml 37.5 bd 37.5 bd 0.375
IV bolus of 0.3mg/kg is to be administered if last SC administration was given more than 8
55 60mg / 0.6ml 41.25 bd 42.5 bd 0.425
hours before balloon inflation (see section 4.2 Posology and method of administration:
60 60mg / 0.6ml 45 bd 45 bd 0.45
Treatment of acute ST-segment Elevation Myocardial Infarction).
65 60mg / 0.6ml 48.75 bd 50 bd 0.5
70 60mg / 0.6ml 52.5 bd 52.5 bd 0.525 In order to assure the accuracy of the small volume to be injected, it is recommended to
100mg/ml 75 60mg / 0.6ml 56.25 bd 57.5 bd 0.575 dilute the drug to 3mg/ml.
Solution for 80 60mg / 0.6ml 60 bd 60 bd 0.60 To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is
Injection 85 80mg / 0.8ml 63.75 bd 65 bd 0.65 recommended to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or
Clexane 90 80mg / 0.8ml 67.5 bd 67.5 bd 0.675 5% dextrose in water) as follows:
syringes 95 80mg / 0.8ml 71.25 bd 72.5 bd 0.725 Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the
100 80mg / 0.8ml 75 bd 75 bd 0.75 complete contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml remaining
105 80mg / 0.8ml 78.75 bd (1) 80 bd (1) 0.80 (1) in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted
110 100mg / 1ml 82.5 bd (1) 82.5 bd (1) 0.825 (1) solution with a syringe for administration into the intravenous line (using an appropriate
115 100mg / 1ml 86.25 bd (1) 87.5 bd (1) 0.875 (1) injection site or port).
120 100mg / 1ml 90 bd (1) 90 bd (1) 0.90 (1)
125 100mg / 1ml 93.75 bd (1) 95 bd (1) 0.95 (1) After dilution is completed, the volume to be injected can be calculated using the following
130 100mg / 1ml 97.5 bd (1) 97.5 bd (1) 0.975 (1) formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table
150mg/ml 135 120mg / 0.8ml 101.25 bd (1) 102 bd (1) 0.68 (1) below. It is recommended to prepare the dilution immediately before use and to discard any
Solution for 140 120mg / 0.8ml 105 bd (1) 105 bd (1) 0.7 (1) remaining solution immediately after use.
Injection 145 120mg / 0.8ml 108.75 bd (1) 111 bd (1) 0.74 (1)
Clexane Forte Volume to be injected through intravenous line after dilution is completed
syringes 150 120mg / 0.8ml 112.5 bd (1) 114 bd (1) 0.76 (1)

(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, Volume to Volume to
followed by 0.75mg/kg dosing for the remaining doses) inject when inject when
Required Required
Please be aware that in some cases it is not possible to achieve an exact dose due to the diluted to diluted to a
Weight dose Weight dose
graduations on the syringe and so some of the volumes recommended in this table have a final final
(0.3mg/kg) (0.3mg/kg)
been rounded up to the nearest graduation. concentration concentration
of 3mg/ml of 3mg/ml
Children: Not recommended, as dosage not established. (Kg) (mg) (ml) (kg) (mg) (ml)
45 13.5 4.5 100 30 10
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal 50 15 5 105 31.5 10.5
impairment and Monitoring; section 5.2 Pharmacokinetic properties). 55 16.5 5.5 110 33 11
60 18 6 115 34.5 11.5
Severe renal impairment: 65 19.5 6.5 120 36 12
A dosage adjustment is required for patients with severe renal impairment (creatinine 70 21 7 125 37.5 12.5
clearance < 30 ml/min), according to the following tables, since enoxaparin sodium 75 22.5 7.5 130 39 13
exposure is significantly increased in this patient population: 80 24 8 135 40.5 13.5
85 25.5 8.5 140 42 14
Dosage adjustments for therapeutic dosage range 90 27 9 145 43.5 14.5
95 28.5 9.5 150 45 15
Standard dosing Severe renal impairment
1 mg/kg SC twice daily 1 mg/kg SC once daily 6. PHARMACEUTICAL PARTICULARS
1.5 mg/kg SC once daily 1 mg/kg SC once daily 6.1 List of excipients
For treatment of acute STEMI in patients <75 years of age Water for Injections
30mg-single IV bolus plus a 1mg/kg SC 30mg-single IV bolus plus a 1mg/kg SC
dose followed by 1mg/kg twice daily. dose followed by 1mg/kg once daily. 6.2 Incompatibilities
(Max 100mg for each of the first two SC (Max 100mg for first SC dose only) Subcutaneous Injection
doses) Clexane should not be mixed with any other injections or infusions.
For treatment of acute STEMI in elderly patients ≥75 years of age Intravenous (Bolus) Injection for acute STEMI indication only
0.75mg/kg SC twice daily without initial Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in
bolus. 1mg/kg SC once daily without initial bolus. dextrose in water.
(Max 75mg for each of the first two SC (Max 100mg for first SC dose only)
doses) 6.3 Shelf life
Do not use after the expiry date, which is stated on the carton. The expiry date refers to the
Dosage adjustments for prophylactic dosage ranges last day of that month.

Standard dosing Severe renal impairment 6.4 Special precautions for storage
40 mg SC once daily 20 mg SC once daily Do not store above 25°C. Do not refrigerate or freeze. Discard any unused product.
20 mg SC once daily 20 mg SC once daily
6.5 Nature and contents of container
The recommended dosage adjustments do not apply to the haemodialysis indication. Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal 6.6 Special precautions for disposal
impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine See section 4.2 Posology and method of administration.
clearance 50-80 ml/min), careful clinical monitoring is advised.
Leaflet revision and issue date (Ref.): 09.09.2013.
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.

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.
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 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.