CLEXANE 40MG/0.4 ML SYRINGES

Active substance: ENOXAPARIN SODIUM

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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.

Clexane® 40mg/0.4ml Syringes
(enoxaparin sodium)

How much will be given to you


PATIENT INFORMATION LEAFLET



The name of your medicine is Clexane 40mg/0.4ml Syringes but will be referred to as Clexane
throughout the leaflet. Other strengths 20mg/0.2ml, 60mg/0.6ml, 80mg/0.8ml & 100mg/1.0ml are
also available.

1) Treating blood clots that are in your blood



Read all of this leaflet carefully before you start using this medicine

Keep this leaflet. You may need to read it again

If you have any further questions, ask your doctor or pharmacist

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist

In
1.
2.
3.
4.
5.
6.
1.

a) Unstable angina



this leaflet:
What Clexane is and what it is used for
Before you use Clexane
How to use Clexane
Possible side-effects
How to store Clexane
Further information






WHAT CLEXANE IS AND WHAT IT IS USED FOR

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.

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. 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. 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)



Clexane can be used to:

2.

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

Clexane works in two ways.



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:

Clexane contains a medicine called enoxaparin sodium. This belongs to a group of medicines called Low
Molecular Weight Heparins.




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

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

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)

If you are under 75 years old







BEFORE YOU USE CLEXANE

Do not have this medicine and tell your doctor, pharmacist or nurse if:


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 after that
The maximum amount of Clexane given for the first two injections is 100mg
The injections will normally be given for up to 8 days

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.

If you are aged 75 years or older

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.





For patients having an operation called Percutaneous Coronary Intervention
(PCI)


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.

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) Stop blood clots forming in the tubes of your dialysis machine

The usual dose is 1mg 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







Taking or using other medicines

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

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 5cm away from these)

Instructions on injecting yourself with Clexane:

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

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.

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.

Operations and anaesthetics

If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is
used, tell your doctor that you are using Clexane. Tell also your doctor if you have any problem with
your spine or if you have ever had spinal surgery.

Pregnancy and breast-feeding

Talk to your doctor before you use this medicine if you are pregnant, might become pregnant, or think
you may be pregnant.
You should not use this medicine if you are pregnant and have a mechanical heart valve as you may be
at increased risk of developing blood clots. Your doctor should discuss this with you.

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.

You should not breast-feed whilst using Clexane. If you are planning to breast-feed, talk to your
doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breastfeeding.

3.

4) Carefully pull off the needle cap from the Clexane syringe. Throw away the cap. The syringe is
pre-filled and ready to use.

HOW TO USE CLEXANE

Having this medicine





Before you use Clexane your doctor or nurse may carry out a blood test
While you are in hospital your doctor or nurse will normally give you Clexane. This is because it
needs to be given as an injection
When you go home you may need to continue to use Clexane and give it to yourself (see below
instructions on how to do this)
Clexane is usually given by injection underneath the skin (subcutaneous)
Page 1 of 2

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).

Other side effects that you should discuss with your nurse or doctor if you are
concerned about them:

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.

Very common (affects more than 1 in 10 people)

Changes in the results of blood tests done to check how your liver is working. These usually go
back to normal after you stop having Clexane.
Rare (affects less than 1 in a 1000 people)

Changes in the potassium levels in your blood. This is more likely to happen in people with kidney
problems or diabetes. Your doctor will be able to check this by carrying out a blood test.
Frequency unknown

If Clexane is used for a long period of time, it may increase the risk of you getting a condition
called ‘osteoporosis’. This is when your bones are more likely to break.

5.

HOW TO STORE AND DISPOSE OF CLEXANE

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

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

Do not store above 25°C. Do not refrigerate or freeze.
The expiry date can be found on the syringe blister container and on the box. It is given as “EXP”
followed by the month and year. Clexane should not be used after the end of that month. If you are
not sure when this is check with your doctor, pharmacist or nurse.
If your doctor tells you to stop taking the medicine, please take them back to the pharmacist for safe
disposal. Only keep the medicine if your doctor tells you to.
If the medicine becomes discoloured or shows any signs of 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 contains

The active ingredient in Clexane is enoxaparin sodium.
Each syringe contains 40mg enoxaparin sodium in water for injections as the active ingredient.

8) Remove the needle by pulling it straight out. You can now let go of the skin fold.

What Clexane looks like and the contents of the pack

Clexane comes in prefilled syringes which are packed in boxes of 10.

Manufacturer:

Manufactured by: Sanofi-Aventis, S.A., Avda de Leganés No 62, 28925 Alcorcón, Madrid, Spain.
Or
Sanofi Winthrop Industrie, Boulevard Industriel, Zone Industrielle (Le Trait), 76580 France.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0257

To avoid bruising, do not rub the injection site after you have injected yourself.

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.

9) Drop the used syringe into the sharps bin provided. Close the container lid tightly and place the
container out of reach of children.

Leaflet revision date: 02.10.12

When the container is full, give it to your doctor or home care nurse for
disposal. Do not put it in the household rubbish.

Clexane® is a registered trademark of May & Baker Limited.

If you have more Clexane than you should

If you think that you have used too much or too little Clexane, tell your doctor, nurse or pharmacist
immediately, even if you have no signs of a problem. If a child accidentally injects or swallows
Clexane, take them to a hospital casualty department straight away.

If you forget to use Clexane

If you forget to give yourself a dose, have it as soon as you remember. Do not give yourself a double
dose on the same day to make up for a forgotten dose. Keeping a diary will help to make sure you do
not miss a dose.

If you stop using Clexane

It is important for you to keep having Clexane injections until your doctor decides to stop them. If you
stop, you could get a blood clot which can be very dangerous.

Blood Tests

Using Clexane may affect the results of some blood tests. If you are going to have a blood test, it is
important to tell your doctor you are having Clexane.

4.

POM

POSSIBLE SIDE-EFFECTS

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

Tell a nurse or doctor or go to hospital straight away if you notice any of the
following side-effects:
Very common (affects more than 1 in 10 people)

Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)

A painful rash of dark red spots under the skin which do not go away when you put pressure on
them. You may also notice pink patches on your skin. These are more likely to appear in the area
you have been injected with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)

Sudden severe headache. This could be a sign of bleeding in the brain.

A feeling of tenderness and swelling in your stomach. You may have bleeding inside your stomach.
Rare (affects less than 1 in a 1000 people)

If you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.

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.

Page 2 of 2

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.

Clexane® 40mg/0.4ml Syringes
(enoxaparin sodium)
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY

Dosage chart for 1mg/kg SC treatment of STEMI
Patient
weight

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

1.
2.

100mg/ml
Solution for
Injection
CLEXANE
syringes

NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION

Clexane® 40mg/0.4ml Syringes

Pre-filled syringes:

20mg Injection Enoxaparin sodium 20mg (equivalent to 2,000 IU anti-Xa activity) in 0.2ml Water for
Injections
40mg Injection Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml Water for
Injections
60mg Injection Enoxaparin sodium 60mg (equivalent to 6,000 IU anti-Xa activity) in 0.6ml Water for
Injections
80mg Injection Enoxaparin sodium 80mg (equivalent to 8,000 IU anti-Xa activity) in 0.8ml Water for
Injections
100mg Injection Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0ml Water
for Injections

100mg/ml
Solution for
Injection
CLEXANE
syringes

PHARMACEUTICAL FORM

4.

CLINICAL PARTICULARS

Solution for injection.

4.2 Posology and method of administration
Adults:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is
20mg (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 40mg (4,000 IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.

Clexane should be administered subcutaneously as a single daily injection of 1.5mg/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

Kg

Syringe label

100mg/ml
Solution for
Injection
CLEXANE
syringes

40
45
50
55
60
65

60mg /
80mg /
80mg /
100mg
100mg
100mg

0.6ml
0.8ml
0.8ml
/ 1ml
/ 1ml
/ 1ml

Dose (mg)
60 od
67.5 od
75 od
82.5 od
90 od
97.5 od

Injection
volume (ml)
0.60
0.675
0.75
0.825
0.90
0.975

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight

Kg

Syringe label

Dose (mg)

150mg/ml
Solution for
Injection
CLEXANE
syringes

70
75
80
85
90
95
100

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

105 od
112.5 od
120 od
127.5 od
135 od
142.5 od
150 od

Injection
volume (ml)
0.70
0.76
0.80
0.86
0.90
0.96
1.00

100mg/ml
Solution for
Injection
CLEXANE
syringes

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

40mg /
60mg /
60mg /
60mg /
60mg /
80mg /
80mg /
80mg /
80mg /
100mg
100mg
100mg
100mg

0.4ml
0.6ml
0.6ml
0.6ml
0.6ml
0.8ml
0.8ml
0.8ml
0.8ml
/ 1ml
/ 1ml
/ 1ml
/ 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

150mg/ml
Solution for
Injection
CLEXANE
syringes

Kg

Syringe label

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

Dose (mg)
105
110
115
120
125
130
135
140
145
150

bd
bd
bd
bd
bd
bd
bd
bd
bd
bd

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)

Dose (mg)
105
110
115
120
125
130
135
140
145
150

bd
bd
bd
bd
bd
bd
bd
bd
bd
bd

(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(1)
(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)

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)
0.75mg/kg
Adjusted
Injection
Patient weight
Kg
Syringe label
Dose (mg)
dosing (mg)
volume (ml)
40
60mg / 0.6ml
30 bd
30 bd
0.30
45
60mg / 0.6ml
33.75 bd
35 bd
0.35
50
60mg / 0.6ml
37.5 bd
37.5 bd
0.375
55
60mg / 0.6ml
41.25 bd
42.5 bd
0.425
60
60mg / 0.6ml
45 bd
45 bd
0.45
65
60mg / 0.6ml
48.75 bd
50 bd
0.5
70
60mg / 0.6ml
52.5 bd
52.5 bd
0.525
75
60mg / 0.6ml
56.25 bd
57.5 bd
0.575
100mg/ml
80
60mg / 0.6ml
60 bd
60 bd
0.60
Solution for
Injection
85
80mg / 0.8ml
63.75 bd
65 bd
0.65
CLEXANE
90
80mg / 0.8ml
67.5 bd
67.5 bd
0.675
syringes
95
80mg / 0.8ml
71.25 bd
72.5 bd
0.725
100
80mg / 0.8ml
75 bd
75 bd
0.75
105
80mg / 0.8ml
78.75 bd (1)
80 bd (1)
0.80 (1)
110
100mg / 1ml
82.5 bd (1)
82.5 bd (1)
0.825 (1)
115
100mg / 1ml
86.25 bd (1)
87.5 bd (1)
0.875 (1)
120
100mg / 1ml
90 bd (1)
90 bd (1)
0.90 (1)
125
100mg / 1ml
93.75 bd (1)
95 bd (1)
0.95 (1)
130
100mg / 1ml
97.5 bd (1)
97.5 bd (1)
0.975 (1)
150mg/ml
135
120mg / 0.8ml
101.25 bd (1)
102 bd (1)
0.68 (1)
Solution for
140
120mg / 0.8ml
105 bd (1)
105 bd (1)
0.7 (1)
Injection
145
120mg / 0.8ml
108.75 bd (1)
111 bd (1)
0.74 (1)
CLEXANE Forte
150
120mg / 0.8ml
112.5 bd (1)
114 bd (1)
0.76 (1)
syringes
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by
0.75mg/kg dosing for the remaining doses).
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.

Children: Not recommended, as dosage not established.

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

Syringe label

Elderly:

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Dose (mg)

Kg

A dose equivalent to 1mg/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 0.5mg/kg (50 IU/kg) for double vascular access or
0.75mg/kg (75 IU/kg) for single vascular access.

The recommended dose is 1mg/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.

Syringe label

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

Prevention of extracorporeal thrombus formation during haemodialysis:

Treatment of unstable angina and non-Q-wave myocardial infarction

Kg

0.4ml
0.6ml
0.6ml
0.6ml
0.6ml
0.8ml
0.8ml
0.8ml
0.8ml
/ 1ml
/ 1ml
/ 1ml
/ 1ml

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.

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.

Patient
weight

40mg /
60mg /
60mg /
60mg /
60mg /
80mg /
80mg /
80mg /
80mg /
100mg
100mg
100mg
100mg

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

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 dose of enoxaparin sodium is 40mg (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:

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

Dose (mg)

(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.

Prophylaxis of venous thromboembolism:

Prophylaxis of venous thromboembolism in medical patients:

Syringe label

Dosage chart for 1mg/kg SC treatment of STEMI
Patient
weight

For full list of excipients, see section 6

3.

Kg

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

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
< 30ml/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
1mg/kg SC twice daily
1mg/kg SC once daily
1.5mg/kg SC once daily
1mg/kg SC once daily
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC dose
30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg twice daily.
followed by 1mg/kg once daily.
(Max 100mg for each of the first two SC doses)
(Max 100mg for first SC dose only)
For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial bolus.
1mg/kg SC once daily without initial bolus.
(Max 75mg for each of the first two SC doses)
(Max 100mg for first SC dose only)

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.

Page 1 of 2

Dosage adjustments for prophylactic dosage ranges
Standard dosing
40mg SC once daily
20mg SC once daily

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

The recommended dosage adjustments do not apply to the haemodialysis indication.

Moderate and mild renal impairment:

Although no dosage adjustments are recommended in patients with moderate renal impairment
(creatinine clearance 30-50ml/min) or mild renal impairment (creatinine clearance 50-80ml/min),
careful clinical monitoring is advised.

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

No dosage adjustments are recommended in obesity or low body weight (see also section 4.4 Special
warnings and precautions for use: Low body weight and Monitoring; section 5.2 Pharmacokinetic
properties).
Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic
disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave
myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial line
of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during
haemodialysis; and via intravenous (bolus) injection through an intravenous line only for the initial
dose of acute STEMI indication and before PCI when needed. It must not be administered by
the intramuscular route.
To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic
safety device.

Subcutaneous injection technique

The prefilled disposable syringe is ready for immediate use. Clexane should be administered when the
patient is lying down by deep subcutaneous injection. The administration should be alternated between
the left and right anterolateral or posterolateral abdominal wall. The whole length of the needle should
be introduced vertically into a skin fold held between the thumb and index finger. The skin fold should
not be released until the injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects the
used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.

Intravenous (Bolus) Injection Technique (for acute STEMI indication only):

For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be
used. Enoxaparin sodium should be administered through an intravenous line. It should not be mixed
or 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

Weight

Required
dose
(0.3mg/kg)

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

6.

(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

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

Required
dose
(0.3mg/kg)
(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

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Water for injections.

6.2 Incompatibilities
Subcutaneous Injection

Clexane should not be mixed with any other injections or infusions.

Intravenous (Bolus) Injection for acute STEMI indication only

Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose
in water.

6.3 Shelf life
36 months

6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers – discard any unused product.

6.5 Nature and contents of container

Clexane comes in prefilled syringes which are packed in boxes of 10.

6.6 Special precautions for disposal

See section 4.2 Posology and method of administration.

10. DATE OF REVISION OF THE TEXT
Leaflet revision date: 02.10.12

Page 2 of 2

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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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