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CLEXANE FORTE 120MG/0.8ML SYRINGES

Active substance(s): ENOXAPARIN SODIUM / ENOXAPARIN SODIUM / ENOXAPARIN SODIUM

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

5












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.
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

Page 4

Clexane® Forte 120mg/0.8ml Syringes
(enoxaparin sodium)

Patient Information Leaflet

How to store and dispose of Clexane Forte
Keep out of the sight and reach of children
Do not store above 25°C.
Do not freeze.
Do not refrigerate.
Store in original pack
Protect from light
Do not use this medicine after the expiry date shown on the carton or
syringe container. If your doctor tells you to stop using this
medicine, return any unused medicine to your pharmacist for safe
disposal. Only keep this medicine, if your doctor tells you to.
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.
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your pharmacist who will tell you what to do.

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 Forte. This normally gets better after a few days.

Ref:1653/121016/1/F

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.

6

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.
Your medicine is called Clexane forte Forte 120mg/0.8ml Syringes but will
be referred to as Clexane Forte throughout the leaflet.

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

Further information

What Clexane Forte contains
• Each pre-filled syringe contains 120mg of enoxaparin sodium
(equivalent to 12,000 IU anti-Xa activity) in 0.8ml water for injections.
What Clexane Forte looks like and contant of the pack
Clexane Forte is a clear, colourless to pale yellow solution.
Clexane Forte comes in packs of 10 syringes.
Product Licence Holder and Manufacturer
These syringes are Manufactured by Sanofi-Winthrop Industrie 180 Rue
Jean Jaures, Maisons-Alfort 94702,France and procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

POM

PL 15184/1653 Clexane Forte 120mg/ml Syringes

Clexane Forte is a registered trademark of Aventis Pharma SA.
Revision date: 12/10/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

1

What Clexane Forte is and what it is used for

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

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 or
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.

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.

Page 1

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 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

Page 2

• If you have a higher risk of getting a clot, you will be given 40mg each

• Decide where you are going to inject the medicine. Change the place

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

Instructions on injecting yourself with Clexane Forte:

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

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 5 cm away from
these)

1) Wash your hands and the area that you will inject with soap and water.
Dry them.

i) NSTEMI type of heart attack
• The usual amount is 1mg for every kilogram of 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
ii) STEMI type of heart attack
If you are under 75 years old
• 30mg of Clexane Forte will be given as an injection into your vein
(intravenous injection using Clexane Forte Multidose Vial or 60, 80 or
100mg Pre-filled syringes)
• At the same time, you will also be given Clexan Forte 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 Forte 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 Forte 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 Forte 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.

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

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.

Note: the safety system allowing release of the protective sleeve can only be
activated when the syringe has been emptied by pressing the plunger all the
way down.
To avoid bruising, do not rub the injection site after you have injected
yourself.

3) Choose an area on the right or left side of your stomach. This should be at
least 5cm 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 Forte syringe. Throw
away the cap. The syringe is pre-filled and ready to use.

9) Drop the used syringe with its protective sleeve into the sharps bin
provided. Close the container lid tightly and place the container out of
reach of children.
When the container is full, give it to your doctor or home care nurse
for disposal. Do not put it in the household rubbish.
If you have 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, 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.

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.

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
• 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

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.

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.
Blood Tests
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.

4

Possible side effects

Like all medicines, Clexane can cause side effects, although not everybody
gets them.

Make sure you hold the skin fold throughout the injection.
6) Hold the syringe so that the needle is pointing downwards (vertically at a
90º angle). Insert the full length of the needle into the skin fold.
Ref:1653/121016/B

Page 3

Ref:1653/121016/1P/F

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY

Clexane ® Forte 120mg/0.8ml Syringes
(enoxaparin sodium)

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, see section 4.2 Posology and method of
administration: Elderly.

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

Dosage chart for 1mg/kg SC treatment of STEMI

1 NAME OF THE MEDICINAL PRODUCT
The name of your medicine is Clexane Forte 120mg/0.8ml Syringes (called Clexane Forte in this leaflet).

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

45
50
55
60

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

45 bd
50 bd
55 bd
60 bd

0.45
0.50
0.55
0.60

65
70
75
80

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

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

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

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

105
110
115
120

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

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

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

125
130
135
140
145
150

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

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

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

Patient
weight

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
120 mg Injection Enoxaparin sodium 120 mg (equivalent to 12,000 IU anti-Xa activity) in 0.8 mL Water for
Injections
for full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.

100mg/ml
Solution for
Injection
CLEXANE
syringes

4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000
IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of thromboembolism has diminished.
In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively.
In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by
subcutaneous injection with the initial dose administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for cancer
and are not otherwise at risk for major bleeding complications, the recommended dosage is 40 mg (4,000 IU)
once daily by subcutaneous injection for 4 weeks with the initial dose administered approximately 12 hours
before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection.
Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full
ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Clexane
treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is established.

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes

150mg/ml
Solution for
Injection
CLEXANE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

60mg / 0.6ml

60 od

0.60

45

80mg / 0.8ml

67.5 od

0.675

50

80mg / 0.8ml

75 od

0.75

55

100mg / 1ml

82.5 od

0.825

60

100mg / 1ml

90 od

0.90

65

100mg / 1ml

97.5 od

0.975

70

120mg / 0.8ml

105 od

0.70

75
80

120mg / 0.8ml

112.5 od

0.76

120mg / 0.8ml

120 od

0.80

85

150mg / 1ml

127.5 od

0.86

90

150mg / 1ml

135 od

95

150mg / 1ml

142.5 od

100

150mg / 1ml

150 od

0.90
0.96
1.00

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

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

100mg/ml
Solution for
Injection
CLEXANE
syringes

150mg/ml
Solution for
Injection
CLEXANE
syringes

150mg/ml
Solution for
Injection
CLEXANE
syringes

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

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

45
50
55
60

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

45 bd
50 bd
55 bd
60 bd

0.45
0.50
0.55
0.60

65
70
75
80

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

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

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

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

105
110
115
120

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

105 bd
110 bd
115 bd
120 bd

0.70
0.74
0.78
0.80

125
130
135
140
145
150

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

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

0.84
0.88
0.90
0.94
0.98
1.00

100mg/ml
Solution for Injection
CLEXANE syringes

150mg/ml Solution
for Injection
CLEXANE
syringes

0.75mg/kg Dose Adjusted dosing Injection volume
(ml)
(mg)
(mg)

Kg

Syringe label

40
45
50
55
60
65
70
75
80

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

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

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

0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60

85
90
95
100
105

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

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

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

0.65
0.675
0.725
0.75
0.80 (1)

110
115
120
125
130

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

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

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

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

135
140
145
150

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

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

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

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

(
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.

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.

Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment and
Monitoring; section 5.2 Pharmacokinetic properties).

Ref:1653/121016/1P/B

Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min),
according to the following tables, since enoxaparin sodium exposure is significantly increased in this patient
population:
Dosage adjustments for therapeutic dosage range

Standard dosing

Severe renal impairment

1 mg/kg SC twice daily

1 mg/kg SC once daily

1.5 mg/kg SC once daily

1 mg/kg SC once daily

Weight Required dose
(0.3mg/kg)

For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg twice daily.
(Max 100mg for each of the first two SC doses)

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

(mg)

(ml)

(Kg)

(mg)

(ml)

45

13.5

4.5

100

30

10

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

Dosage adjustments for prophylactic dosage ranges

Standard dosing

Severe renal impairment

40 mg SC once daily

20 mg SC once daily

20 mg SC once daily

20 mg SC once daily

The recommended dosage adjustments do not apply to the haemodialysis indication.
*The Clexane 100mg/ml 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.

6.2

15

5

105

31.5

10.5

55

16.5

5.5

110

33

11

60

18

6

115

34.5

11.5

65

19.5

6.5

120

36

12

70

21

7

125

37.5

12.5

75

22.5

7.5

130

39

13

80

24

8

135

40.5

13.5

85

25.5

8.5

140

42

14

90

27

9

145

43.5

14.5

95

28.5

9.5

150

45

15

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

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

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/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes). It must
not be administered by the intramuscular route.

50

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections

Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 Special warnings and precautions for use:

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).

Weight Required dose
(0.3mg/kg)

6.3

Shelf life
24 months.

6.4

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

6.5 Nature and contents of container
Nature and contents of container Solution for injection in Type I glass prefilled syringes fitted with
injection needle and an automatic safety device in packs of 10.

To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic safety device
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be administered when the patient
is lying down by deep subcutaneous injection. The administration should be alternated between the left and
right anterolateral or posterolateral abdominal wall. The whole length of the needle should be introduced
vertically into a skin fold held between the thumb and index finger. The skin fold should not be released until
the injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects the used
needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection technique (for acute STEMI indication only)
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be used.
Enoxaparin sodium should be administered through an intravenous line. It should not be mixed or
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

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

(Kg)

For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial bolus.
(Max 75mg for each of the first two SC doses)

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

6.6

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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 16 December 1999
Date of latest renewal: 4 February 2009

10

DATE OF REVISION OF THE TEXT
06/2015

Revision date: 08/04/2016

Expand Transcript

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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