CLEXANE 40MG/0.4ML SYRINGES
Active substance(s): ENOXAPARIN SODIUM / SODIUM ENOXAPARIN
PACKAGE LEAFLET: INFORMATION FOR THE USER
®
®
Pregnancy and breast-feeding
(enoxaparin sodium)
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strengths (Clexane 60mg/0.6ml, 80mg/0.8ml and 100mg/1ml Syringes).
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.
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
You should not breast-feed whilst using Clexane. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.
CLEXANE 20mg/0.2ml SYRINGES / CLEXANE 40mg/0.4ml SYRINGES
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
3. How to use Clexane
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
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)
1. What Clexane is and what it is used for
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.
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.
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:
4. Possible side-effects
1) Wash your hands and the area that you will inject with soap and water. Dry them.
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.
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.
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.
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.
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.
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.
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 - the needle end 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.
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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
•
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Clexane after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Do not store in a refrigerator or freezer.
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.
•
6. Further Information
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.
What Clexane contains
• Each 20mg pre-filled syringe contains 20mg (2,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
• Each 40mg pre-filled 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
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.
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass prefilled syringe fitted with an injection
needle and needle cap. It is supplied in packs of 10 syringes.
POM
PL No: 15814/0972
The Manufacturer is CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd.,
Csanyikvolgy Site, Miskolc, Csanyikvolgy, H-3510, Hungary and is procured from
within the EU and repackaged by the Product Licence Holder: OPD Laboratories
Limited, colonial Way, Watford, Herts WD24 4PR.
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.) 25.11.2016.
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
®
®
Pregnancy and breast-feeding
(enoxaparin sodium)
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strengths (Clexane 60mg/0.6ml, 80mg/0.8ml and 100mg/1ml Syringes).
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.
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
You should not breast-feed whilst using Clexane. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.
CLEXANE 20mg/0.2ml SYRINGES / CLEXANE 40mg/0.4ml SYRINGES
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
3. How to use Clexane
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
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)
1. What Clexane is and what it is used for
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.
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.
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:
4. Possible side-effects
1) Wash your hands and the area that you will inject with soap and water. Dry them.
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.
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.
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.
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.
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.
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.
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 - the needle end 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.
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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
•
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Clexane after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Do not store in a refrigerator or freezer.
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.
•
6. Further Information
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.
What Clexane contains
• Each 20mg pre-filled syringe contains 20mg (2,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
• Each 40mg pre-filled 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
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.
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass prefilled syringe fitted with an injection
needle and needle cap. It is supplied in packs of 10 syringes.
POM
PL No: 15814/0972
The Manufacturer is Sanofi Winthrop Industrie, Boulevard Industrial, Le Trait, F-76580,
France and is procured from within the EU and repackaged by the Product Licence
Holder: OPD Laboratories Limited, colonial Way, Watford, Herts WD24 4PR.
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.) 25.11.2016.
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
®
®
Pregnancy and breast-feeding
(enoxaparin sodium)
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strengths (Clexane 60mg/0.6ml, 80mg/0.8ml and 100mg/1ml Syringes).
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.
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
You should not breast-feed whilst using Clexane. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.
CLEXANE 20mg/0.2ml SYRINGES / CLEXANE 40mg/0.4ml SYRINGES
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
3. How to use Clexane
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
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)
1. What Clexane is and what it is used for
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.
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.
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:
4. Possible side-effects
1) Wash your hands and the area that you will inject with soap and water. Dry them.
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.
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.
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.
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.
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.
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.
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 - the needle end 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.
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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
•
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Clexane after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Do not store in a refrigerator or freezer.
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.
•
6. Further Information
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.
What Clexane contains
• Each 20mg pre-filled syringe contains 20mg (2,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
• Each 40mg pre-filled 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
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.
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass prefilled syringe fitted with an injection
needle and needle cap. It is supplied in packs of 10 syringes.
POM
PL No: 15814/0972
The Manufacturer is Sanofi-aventis S.A., Avda de Leganes n°62, 28925 Alcorcon,
Madrid, Spain and is procured from within the EU and repackaged by the Product
Licence Holder: OPD Laboratories Limited, colonial Way, Watford, Herts WD24 4PR.
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.) 25.11.2016.
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
Clexane® 60mg/0.6ml Syringes/ Clexane® 80mg/0.8ml Syringes
Clexane® 100mg/1ml Syringes
Patient weight
Kg
Syringe label
Dose (mg)
150mg/ml
Solution for
Injection
Clexane
Forte syringes
105
110
115
120
125
130
135
140
145
150
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
105 bd
110 bd
115 bd
120 bd
125 bd
130 bd
135 bd
140 bd
145 bd
150 bd
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
1. NAME OF THE MEDICINAL PRODUCT
This product is available using any of the above names but will be referred to as Clexane
throughout the following leaflet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.4ml
Each 60mg pre-filled syringe contains 60mg (6000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.6ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 1ml
the active
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.
the active
the active
the active
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.
the active
For full list of excipients, see section 6.1
Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight
Kg
Syringe label
Dose (mg)
100mg/ml
Solution for
Injection
Clexane
syringes
40
45
50
55
60
65
70
75
80
85
90
95
100
40mg / 0.4ml
60mg / 0.6ml
60mg /
®
®
Pregnancy and breast-feeding
(enoxaparin sodium)
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strengths (Clexane 60mg/0.6ml, 80mg/0.8ml and 100mg/1ml Syringes).
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.
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
You should not breast-feed whilst using Clexane. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.
CLEXANE 20mg/0.2ml SYRINGES / CLEXANE 40mg/0.4ml SYRINGES
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
3. How to use Clexane
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
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)
1. What Clexane is and what it is used for
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.
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.
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:
4. Possible side-effects
1) Wash your hands and the area that you will inject with soap and water. Dry them.
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.
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.
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.
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.
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.
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.
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 - the needle end 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.
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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
•
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Clexane after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Do not store in a refrigerator or freezer.
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.
•
6. Further Information
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.
What Clexane contains
• Each 20mg pre-filled syringe contains 20mg (2,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
• Each 40mg pre-filled 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
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.
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass prefilled syringe fitted with an injection
needle and needle cap. It is supplied in packs of 10 syringes.
POM
PL No: 15814/0972
The Manufacturer is CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd.,
Csanyikvolgy Site, Miskolc, Csanyikvolgy, H-3510, Hungary and is procured from
within the EU and repackaged by the Product Licence Holder: OPD Laboratories
Limited, colonial Way, Watford, Herts WD24 4PR.
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.) 25.11.2016.
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
®
®
Pregnancy and breast-feeding
(enoxaparin sodium)
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strengths (Clexane 60mg/0.6ml, 80mg/0.8ml and 100mg/1ml Syringes).
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.
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
You should not breast-feed whilst using Clexane. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.
CLEXANE 20mg/0.2ml SYRINGES / CLEXANE 40mg/0.4ml SYRINGES
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
3. How to use Clexane
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
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)
1. What Clexane is and what it is used for
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.
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.
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:
4. Possible side-effects
1) Wash your hands and the area that you will inject with soap and water. Dry them.
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.
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.
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.
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.
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.
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.
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 - the needle end 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.
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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
•
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Clexane after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Do not store in a refrigerator or freezer.
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.
•
6. Further Information
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.
What Clexane contains
• Each 20mg pre-filled syringe contains 20mg (2,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
• Each 40mg pre-filled 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
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.
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass prefilled syringe fitted with an injection
needle and needle cap. It is supplied in packs of 10 syringes.
POM
PL No: 15814/0972
The Manufacturer is Sanofi Winthrop Industrie, Boulevard Industrial, Le Trait, F-76580,
France and is procured from within the EU and repackaged by the Product Licence
Holder: OPD Laboratories Limited, colonial Way, Watford, Herts WD24 4PR.
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.) 25.11.2016.
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
®
®
Pregnancy and breast-feeding
(enoxaparin sodium)
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strengths (Clexane 60mg/0.6ml, 80mg/0.8ml and 100mg/1ml Syringes).
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.
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
You should not breast-feed whilst using Clexane. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.
CLEXANE 20mg/0.2ml SYRINGES / CLEXANE 40mg/0.4ml SYRINGES
Ask your doctor or pharmacist for advice before taking any medicine if you are
pregnant or breast-feeding.
3. How to use Clexane
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
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)
1. What Clexane is and what it is used for
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.
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.
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:
4. Possible side-effects
1) Wash your hands and the area that you will inject with soap and water. Dry them.
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.
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.
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.
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.
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.
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.
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 - the needle end 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.
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
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
•
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Clexane after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Do not store in a refrigerator or freezer.
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.
•
6. Further Information
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.
What Clexane contains
• Each 20mg pre-filled syringe contains 20mg (2,000 IU anti-Xa activity) of the active
substance, enoxaparin sodium, in 0.2ml
• Each 40mg pre-filled 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
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.
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass prefilled syringe fitted with an injection
needle and needle cap. It is supplied in packs of 10 syringes.
POM
PL No: 15814/0972
The Manufacturer is Sanofi-aventis S.A., Avda de Leganes n°62, 28925 Alcorcon,
Madrid, Spain and is procured from within the EU and repackaged by the Product
Licence Holder: OPD Laboratories Limited, colonial Way, Watford, Herts WD24 4PR.
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.) 25.11.2016.
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
Clexane® 60mg/0.6ml Syringes/ Clexane® 80mg/0.8ml Syringes
Clexane® 100mg/1ml Syringes
Patient weight
Kg
Syringe label
Dose (mg)
150mg/ml
Solution for
Injection
Clexane
Forte syringes
105
110
115
120
125
130
135
140
145
150
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
105 bd
110 bd
115 bd
120 bd
125 bd
130 bd
135 bd
140 bd
145 bd
150 bd
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
1. NAME OF THE MEDICINAL PRODUCT
This product is available using any of the above names but will be referred to as Clexane
throughout the following leaflet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.4ml
Each 60mg pre-filled syringe contains 60mg (6000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.6ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 1ml
the active
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.
the active
the active
the active
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.
the active
For full list of excipients, see section 6.1
Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight
Kg
Syringe label
Dose (mg)
100mg/ml
Solution for
Injection
Clexane
syringes
40
45
50
55
60
65
70
75
80
85
90
95
100
40mg / 0.4ml
60mg / 0.6ml
60mg /
Other drugs
- BLOPRESS TABLETS 8MG
- BIFRIL 30MG FILM-COATED TABLETS
- CEFALEXIN 500MG CAPSULES
- MAROL 100MG PROLONGED-RELEASE TABLETS
- PARIET 20MG GASTRO-RESISTANT TABLETS
- SKUDEXA 75 MG/25 MG FILM-COATED TABLETS
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