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CLEXANE FORTE 120MG/0.8ML SYRINGES

Active substance(s): ENOXAPARIN SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Clexane® Forte 120mg/0.8ml Syringes
(enoxaparin sodium)
This product is available using the above name but will be referred to as Clexane Forte
throughout the following leaflet. Please note this leaflet also contains information about
another strength (Clexane Forte 150mg/1ml Syringes).
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, pharmacist or nurse.
• 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, pharmacist or nurse.
In this leaflet:
1. What Clexane Forte is and what it is used for
2. Before you use Clexane Forte
3. How to use Clexane Forte
4. Possible side-effects
5. How to store and dispose of Clexane Forte
6. Further information
1. What Clexane Forte is and what it is used for
Clexane Forte contains a medicine called enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight Heparins.
Clexane Forte 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 Forte 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 Forte
Do not have this medicine and tell your doctor if:
• You are allergic (hypersensitive) to enoxaparin sodium. 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 are bleeding heavily
• 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 take 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 Forte.
Take special care with Clexane Forte
Check with your doctor or pharmacist before having this medicine if:









You have high blood pressure which is not controlled by medication
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, pharmacist or
nurse before having Clexane Forte.
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 Forte can affect the way some other medicines work.
Also some medicines can affect the way Clexane Forte works.
In particular, do not take 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 - used to stop blood clots from forming. Aspirin may also be used for pain
relief and in medicines for colds and flu
• Dipyridamole, clopidogrel, or other medicines - used to stop blood clots forming
• Streptokinase, alteplase and reteplase - used to dissolve blood clots after a heart
attack
• Dextran injection - used to replace blood volume
• Ibuprofen, diclofenac, ketorolac or other medicines used to treat pain and swelling in
arthritis and other illnesses
• Prednisolone, dexamethasone or other steroid 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 Forte
Your doctor may change one of your medicines or take regular blood tests to check that
taking these medicines with Clexane Forte 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 Forte. Tell also your doctor
if you have any problem with your spine or if you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you are given this medicine if you are pregnant, might become
pregnant or think you may be pregnant.
You should not use this medicine if you are pregnant and have a mechanical heart valve as
you may be at increased risk of developing blood clots. Your doctor should discuss this with
you.
You should not breast-feed whilst using Clexane Forte. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.
Ask your doctor, pharmacist or nurse for advice before taking any medicine if you are
pregnant or breast-feeding.
3. How to use Clexane Forte
Having this medicine
• Before you have Clexane Forte your doctor or nurse may carry out a blood test
• While you are in hospital your doctor or nurse will normally give you Clexane Forte.
This is because it needs to be given as an injection
• When you go home you may need to continue to use Clexane Forte and give it to
yourself (see below instructions on how to do this)
• Clexane Forte is usually given by injection underneath the skin (subcutaneous)
• Do not inject Clexane Forte into a muscle (intramuscular)
If you are not sure why you are receiving Clexane Forte or have any questions about how
much Clexane Forte is being given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you in hospital
• Your doctor will decide how much to give you. The amount of Clexane Forte 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
Forte
Adults including the elderly
1) Treating blood clots that are in your blood
• The usual dose is 1.5mg for every kilogram of your weight, each day
• Clexane Forte 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 dose is 1mg for every kilogram of your weight, every 12 hours
• Clexane Forte 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 bed rest 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 Forte 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
Forte 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 Forte 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 Forte, 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 1mg for every kilogram of your weight
• Clexane Forte 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
Children
This medicine should not be given to children.
How to give yourself an injection of Clexane Forte
If you are able to give Clexane Forte 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 Forte

4. Possible side effects

• 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 Forte should be
injected just under the skin on your stomach, but not too near the belly button or any
scar tissue (at least 5cm away from these)

Like all medicines, Clexane Forte 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:

Instructions on injecting yourself with Clexane Forte:
1) Wash your hands and the area that you will inject with soap and water. Dry them.

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

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.

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:

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 5cm 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 Forte 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.

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
Forte. 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 Forte 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 Forte.
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.

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.

Frequency unknown
• If Clexane Forte 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 Forte

8) Remove the needle by pulling it straight out. You can now let go of the skin fold.
To avoid bruising, do not rub the injection site after you have injected yourself.
9) Drop the used syringe – needle first – into the sharps bin provided. Close the container
lid tightly and place the container out of reach of children.
When the container is full, give it to your doctor or home care nurse for disposal. Do
not put it in the household rubbish.
If you have too much or too little Clexane Forte
If you think that you have used too much or too little Clexane Forte, tell your doctor, nurse
or pharmacist immediately, even if you have no signs of a problem. If a child accidentally
injects or swallows Clexane Forte, take them to a hospital casualty department straight
away.
If you forget to use Clexane Forte
If you forget to give yourself a dose, have it as soon as you remember. Do not give yourself
a double dose on the same day to make up for a forgotten dose. Keeping a diary will help
to make sure you do not miss a dose.
If you stop using Clexane Forte
It is important for you to keep having Clexane Forte injections until your doctor decides to
stop them. If you stop, you could get a blood clot which can be very dangerous.

• Keep this medicine in a safe place where children cannot see or reach it.
• Do not use Clexane Forte after the expiry date, which is stated on the carton. The expiry
date refers to the last day of that month.
• Do not store above 25°C. Do not refrigerate or freeze.
• 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
What Clexane Forte contains
• Each syringe contains 120mg Enoxaparin sodium (12,000 I.U. anti-xa activity) in 0.8ml
water for injections.
• The other ingredient is water for injections
What Clexane Forte looks like and contents of the pack
Clexane Forte is a clear colourless to pale yellow solution in a glass pre-filled syringe fitted
with an injection needle and needle cap. It is supplied in packs of 10 syringes.
POM

PL No: 15814/0993

Blood Tests

The Manufacturer is Sanofi Winthrop Industrie, 180 Rue Jean Jaures B.P. 40, Maison
Alfort, France and procured from within the EU and repackaged by the Product Licence
Holder OPD Laboratories Limited, Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Using Clexane Forte 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 Forte.

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.) 08.10.2015.
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

Clexane® Forte 120mg/0.8ml Syringes

(enoxaparin sodium)
This product is available using the above name but will be referred to as Clexane
throughout the following leaflet. Please note this leaflet also contains information about
another strength (Clexane Forte 150mg/1ml Syringes).
The following information is extracted from the SPC.
Technical information for the administration of Clexane Syringes
1. NAME OF THE MEDICINAL PRODUCT
Clexane® Forte 120mg/0.8ml Syringes.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
Each syringe contains 120mg Enoxaparin sodium (12,000 I.U. anti-xa activity) in 0.8ml
water for injections.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
105
120mg / 0.8ml
105 bd
0.70
110
120mg / 0.8ml
110 bd
0.74
115
120mg / 0.8ml
115 bd
0.78
150mg/ml
120
120mg / 0.8ml
120 bd
0.80
Solution for
125
150mg / 1ml
125 bd
0.84
Injection
Clexane
130
150mg / 1ml
130 bd
0.88
Forte
135
150mg / 1ml
135 bd
0.90
syringes
140
150mg / 1ml
140 bd
0.94
145
150mg / 1ml
145 bd
0.98
150
150mg / 1ml
150 bd
1.00
Please be aware that in some cases it is not possible to achieve an exact dose due to
the graduations on the syringe and so some of the volumes recommended in this table
have been rounded up to the nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg (using the
Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes) 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, s ee section 4.2 Posology and method of
administration: Elderly.

4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended
dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or
until the risk of thromboembolism has diminished. In patients undergoing surgery, the
initial dose should be given approximately 2 hours pre-operatively.
In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40
mg (4,000 IU) daily by subcutaneous injection with the initial dose administered
approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or
pelvic surgery for cancer and are not otherwise at risk for major bleeding
complications, the recommended dosage is 40 mg (4,000 IU) once daily by
subcutaneous injection for 4 weeks with the initial dose administered approximately 12
hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by
subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a
minimum of 6 days and continued until the return to full ambulation, for a maximum of
14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5
mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until
adequate oral anticoagulation is established.
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
40
60mg / 0.6ml
60 od
0.60
100mg/ml
45
80mg / 0.8ml
67.5 od
0.675
Solution for
50
80mg / 0.8ml
75 od
0.75
Injection
55
100mg / 1ml
82.5 od
0.825
Clexane
60
100mg / 1ml
90 od
0.90
syringes
65
100mg / 1ml
97.5 od
0.975
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
70
120mg / 0.8ml
105 od
0.70
150mg/ml
75
120mg / 0.8ml
112.5 od
0.76
Solution for
80
120mg / 0.8ml
120 od
0.80
Injection
85
150mg / 1ml
127.5 od
0.86
Clexane
90
150mg / 1ml
135 od
0.90
Forte
95
150mg
/
1ml
142.5
od
0.96
syringes
100
150mg / 1ml
150 od
1.00
Please be aware that in some cases it is not possible to achieve an exact dose due to
the graduations on the syringe and so some of the volumes recommended in this table
have been rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous
injection, administered concurrently with oral aspirin (100 to 325mg once daily).
Treatment with Clexane in these patients should be prescribed for a minimum of 2
days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8
days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
100mg/ml
65
80mg / 0.8ml
65 bd
0.65
Solution for
Injection
70
80mg / 0.8ml
70 bd
0.70
Clexane
75
80mg / 0.8ml
75 bd
0.75
syringes
80
80mg / 0.8ml
80 bd
0.80
85
100mg / 1ml
85 bd
0.85
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00

Dosage chart for 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 / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

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

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

Dosage chart for 1mg/kg SC treatment of STEMI
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 (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)

105 bd (1)
110 bd (1)
115 bd (1)
120 bd (1)
125 bd (1)
130 bd (1)
135 bd (1)
140 bd (1)
145 bd (1)
150 bd (1)

Injection
volume (ml)
0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1)
0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1)

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses
only, followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to
the graduations on the syringe and so some of the volumes recommended in this table
have been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin
specific) enoxaparin sodium should be given between 15 minutes before and 30
minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic
acid (ASA) as soon as they are identified as having STEMI and maintained under (75
to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital
discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last
enoxaparin sodium SC administration was given less than 8 hours before balloon
inflation, no additional dosing is needed. If the last SC administration was given more
than 8 hours before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin sodium
should be administered (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or
100mg prefilled syringes).
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the
beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings
are found, such as after a longer than normal session, a further dose of 0.5 to 1mg/kg
(50 to 100 IU/kg) may be given. For patients at a high risk of haemorrhage the dose
should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg
(75 IU/kg) for single vascular access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients
≥75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC
every 12 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg
dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless
kidney function is impaired (see also section 4.2 Posology and method of
administration: Renal impairment; section 4.4 Special warnings and precautions for
use: Haemorrhage in the elderly; Renal impairment and Monitoring; section 5.2
Pharmacokinetic properties).

Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged >75 years only)
Adjusted
Syringe
0.75mg/kg
Patient weight
Kg
dosing
label
Dose (mg)
(mg)
40
60mg / 0.6ml
30 bd
30 bd
45
60mg / 0.6ml
33.75 bd
35 bd
50
60mg / 0.6ml
37.5 bd
37.5 bd
55
60mg / 0.6ml
41.25 bd
42.5 bd
60
60mg / 0.6ml
45 bd
45 bd
65
60mg / 0.6ml
48.75 bd
50 bd
70
60mg / 0.6ml
52.5 bd
52.5 bd
75
60mg / 0.6ml
56.25 bd
57.5 bd
100mg/ml
80
60mg / 0.6ml
60 bd
60 bd
Solution for
Injection
85
80mg / 0.8ml
63.75 bd
65 bd
Clexane
90
80mg / 0.8ml
67.5 bd
67.5 bd
Syringes
95
80mg / 0.8ml
71.25 bd
72.5 bd
100 80mg / 0.8ml
75 bd
75 bd
78.75 bd (1)
80 bd (1)
105 80mg / 0.8ml
82.5 bd (1)
82.5 bd (1)
110
100mg / 1ml
86.25 bd (1)
87.5 bd (1)
115
100mg / 1ml
90 bd (1)
90 bd (1)
120
100mg / 1ml
93.75 bd (1)
95 bd (1)
125
100mg / 1ml
97.5 bd (1)
97.5 bd (1)
130
100mg / 1ml
120mg /
101.25 bd (1)
102 bd (1)
135
0.8ml
150mg/ml
120mg /
105 bd (1)
105 bd (1)
140
Solution for
0.8ml
Injection
120mg /
Clexane Forte
108.75 bd (1)
111 bd (1)
145
0.8ml
Syringes
120mg /
112.5 bd (1)
114 bd (1)
150
0.8ml

Injection
volume
(ml)
0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60
0.65
0.675
0.725
0.75
0.80 (1)
0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)
0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1)

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

Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be
administered when the patient is lying down by deep subcutaneous injection. The
administration should be alternated between the left and right anterolateral or
posterolateral abdominal wall. The whole length of the needle should be introduced
vertically into a skin fold held between the thumb and index finger. The skin fold
should not be released until the injection is complete.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled
syringes can be used. Enoxaparin sodium should be administered through an
intravenous line. It should not be mixed or co-administered with other medications. To
avoid the possible mixture of enoxaparin sodium with all other drugs, the intravenous
access chosen should be flushed with a sufficient amount of saline or dextrose
solution prior to and following the intravenous bolus administration of enoxaparin
sodium to clear the port of drug. Enoxaparin sodium may be safely administered with
normal saline solution (0.9%) or 5% dextrose in water.
• Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60,
80 or 100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe.
The 30mg dose can then be directly injected into an injection site in the intravenous line.
• Additional bolus for PCI when last SC administration was given more than 8
hours before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an
additional IV bolus of 0.3mg/kg is to be administered if last SC administration was
given more than 8 hours before balloon inflation (see section 4.2 Posology and
method of administration: Treatment of acute ST-segment Elevation Myocardial
Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended
to dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is
recommended to use a 50ml infusion bag (i.e. using either normal saline solution
(0.9%) or 5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the
complete contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml
remaining in the bag. Gently mix the contents of the bag. Withdraw the required
volume of diluted solution with a syringe for administration into the intravenous line
(using an appropriate injection site or port).
After dilution is completed, the volume to be injected can be calculated using the
following formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using
the table below. It is recommended to prepare the dilution immediately before use and
to discard any remaining solution immediately after use.
Volume to be injected through intravenous line after dilution is completed

Dosage adjustments for therapeutic dosage range
Standard dosing
Severe renal impairment
1 mg/kg SC twice daily
1 mg/kg SC once daily
1.5 mg/kg SC once daily
1 mg/kg SC once daily
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus* plus a 1mg/kg
30mg-single IV bolus* plus a 1mg/kg SC
SC dose followed by 1mg/kg twice
dose followed by 1mg/kg once daily.
daily.
(Max 100mg for first SC dose only)
(Max 100mg for each of the first two
SC doses)
For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial
1mg/kg SC once daily without initial
bolus.
bolus.
(Max 75mg for each of the first two SC
(Max 100mg for first SC dose only)
doses)
Dosage adjustments for prophylactic dosage ranges
Standard dosing
40 mg SC once daily
20 mg SC once daily

Severe renal impairment
20 mg SC once daily
20 mg SC once daily

The recommended dosage adjustments do not apply to the haemodialysis indication.
* The Clexane 100mg/1ml Multidose Vial or Clexane 60mg, 80mg or 100mg pre-filled
syringes should be used to administer the IV dose.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal
impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine
clearance 50-80 ml/min), careful clinical monitoring is advised.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 Special warnings
and precautions for use: Spinal/epidural anaesthesia.

Weight

Required
dose
(0.3mg/kg)

(Kg)
45
50
55
60
65
70
75
80
85
90
95

(mg)
13.5
15
16.5
18
19.5
21
22.5
24
25.5
27
28.5

Volume to
inject when
diluted to
a final
concentration
of 3mg/ml
(ml)
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5

Weight

Required
dose
(0.3mg/kg)

(kg)
100
105
110
115
120
125
130
135
140
145
150

(mg)
30
31.5
33
34.5
36
37.5
39
40.5
42
43.5
45

Volume to
inject when
diluted to a
final
concentration
of 3mg/ml
(ml)
10
10.5
11
11.5
12
12.5
13
13.5
14
14.5
15

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%)
or 5% dextrose in water.
6.3 Shelf life
24 months.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Clexane Forte are single dose containers - discard any unused product.

Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight: No dosage adjustments are recommended in obesity or low body weight
(see also section 4.4 Special warnings and precautions for use: Low body weight and
Monitoring; section 5.2 Pharmacokinetic properties).
Clexane is administered by subcutaneous injection for the prevention of venous
thromboembolic disease, treatment of deep vein thrombosis or for the treatment of
unstable angina, non-Q-wave myocardial infarction and acute ST elevation myocardial
infarction (STEMI); through the arterial line of a dialysis circuit for the prevention of
thrombus formation in the extra-corporeal circulation during haemodialysis; and via
intravenous (bolus) injection through an intravenous line only for the initial dose of
acute STEMI indication and before PCI when needed (using the Clexane 100mg/1ml
Multidose Vial or 60mg, 80mg or 100mg prefilled syringes). It must not be
administered by the intramuscular route.

6.5 Nature and contents of container
Clexane Forte is a clear colourless to pale yellow solution in a glass pre-filled
syringe fitted with an injection needle and needle cap. It is supplied in packs of 10
syringes.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
10. DATE OF REVISION OF THE TEXT
08.10.2015
POM

PL No: 15814/0993

The Manufacturer is Sanofi Winthrop Industrie, 180 Rue Jean Jaures B.P. 40, Maison
Alfort, France and procured from within the EU and repackaged by the Product Licence
Holder OPD Laboratories Limited, Unit 6 Colonial Way, Watford, Herts WD24 4PR.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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