Skip to Content

UK Edition. Click here for US version.

CLEXANE SYRINGES 80MG/0.8ML

Active substance(s): ENOXAPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet
Clexane® Syringes 80mg/0.8ml
(enoxaparin sodium)

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.

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.
Your medicine is also available in 20mg, 40mg, 60mg and
100mg syringes.

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 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.

In this leaflet
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side – effects
5. How to store Clexane
6. Further Information
1. What Clexane is and what it is used for
The name of your medicine is Clexane Syringes
80mg/0.8ml but will be referred to as Clexane throughout
the remainder of this leaflet. Clexane contains a medicine
called enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting any bigger.
This helps your body to break them down and stop
them causing you harm.
2) Stopping blood clots forming in your blood
Clexane can be used to:
• Treat blood clots that are in your blood
• Stop blood clots forming in your blood in the following
situations:
• Unstable angina (where not enough blood gets to
your heart)
• After an operation or long periods of bed rest due
to illness
• After you have had a heart attack
• Stop blood clots forming in the tubes of your dialysis
machine (used for people with kidney problems)
2. Before you use Clexane
Do not have this medicine and tell your doctor,
pharmacist or nurse if:
• You are allergic (hypersensitive) to enoxaparin sodium or
any of the other ingredients of Clexane (listed in Section
6: Further information)
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat
or tongue
• You are allergic to heparin or other Low Molecular
Weight Heparins such as tinzaparin or dalteparin
• You have a problem with bruising or bleeding too easily
• You have an ulcer in your stomach or gut (intestine)
• You have had a stroke caused by bleeding in the brain
• You have an infection in your heart
• You are using the medicine called heparin to treat blood
clots

Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are
taking or have recently taken any other medicines. This
includes medicines you buy without a prescription,
including herbal medicines. This is because Clexane can
affect the way some other medicines work. Also some
medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your
doctor if:
• You are using the medicine called heparin to treat blood
clots
Tell your doctor if you are taking any of the following
medicines:
• Warfarin – used for thinning the blood
• Aspirin, dipyridamole, clopidogrel or other medicines –
used to stop blood clots forming
• Dextran injection – used as a blood replacer
• Ibuprofen, diclofenac, ketorolac or other medicines –
used to treat pain and swelling in arthritis and other
illnesses
• Prednisolone, dexamethasone or other medicines –
used to treat asthma, rheumatoid arthritis and other
conditions
• Water tablets (diuretics) such as spironolactone,
triamterene or amiloride. These may increase the
levels of potassium in your blood when taken with
Clexane.
Your doctor may change one of your medicines or take
regular blood tests to check that taking these medicines
with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an operation
where an epidural or spinal anaesthetic is used, tell your
doctor that you are using Clexane. Tell also your doctor if
you have any problems 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.
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 breast-feeding.
3. 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)
• Do not inject Clexane into a muscle (intramuscular)
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.
How much will be given to you
• Your doctor will decide how much to give you. The
amount of Clexane given to you will depend on the
reason it is being used
• If you have problems with your kidneys, you may be
given a smaller amount of Clexane.
1) Treating blood clots that are in your blood
• The usual dose is 1.5mg for every kilogram of your
weight, each day
• Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in the
following situations:
a) Unstable angina
• The usual amount is 1mg for every kilogram of your
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 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 each day for 7 to 10 days. If
you are going to have an operation, your first injection
will usually be given 2 hours before your operation
• If you have a higher risk of getting a clot, you will be
given 40mg each day for 7 to 28 days. If you are going
to have an operation, your first injection will usually be
given 12 hours before your operation

• If you are bedridden due to illness, you will be normally
be given 40mg of Clexane each day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of heart attack
called NSTEMI or STEMI.
The amount of Clexane given to you will depend on your
age and the kind of heart attack you have had.
i) NSTEMI type of heart attack
• The usual amount is 1mg for every kilogram of weight,
every 12 hours
• Clexane will usually be given for 2 to 8 days. Your doctor
will normally ask you to take aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
• 30mg of Clexane will be given as an injection into your
vein (intravenous injection using Clexane Multidose Vial
or 60, 80 or 100mg Pre-filled syringes)
• At the same time, you will also be given Clexane as an
injection under your skin (subcutaneous injection). The
usual dose is 1mg for every kilogram of your weight.
• Then you will be given 1mg for every kilogram of your
weight every 12 hours
• The maximum amount of Clexane given for the first two
injections is100mg
• The injections will normally be given for up to 8 days
If you are aged 75 years or older
• Your doctor or nurse will give you injections of Clexane
under your skin (subcutaneous injection)
• The usual dose is 0.75mg for every kilogram of your
weight, every 12 hours
• The maximum amount of Clexane given for the first two
injections is 75mg.
For patients having an operation called Percutaneous
Coronary Intervention (PCI)
• Depending on when you were last given Clexane, your
doctor may decide to give an additional dose of Clexane
before a PCI operation. This is by injection into your vein
(intravenous using Clexane Multidose Vial or 60, 80 or
100mg Pre-filled syringes)
3) Stopping blood clots forming in the tubes of your
dialysis machine
• The usual dose is 1 mg for every kilogram of your weight
• Clexane is added to the tube leaving the body (arterial
line) at the start of the dialysis session
• This amount is usually enough for a 4 hour session.
However, your doctor may give you a further dose of 0.5
to 1mg for every kilogram of your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your doctor or
nurse will show you how to do this. Do not try to inject
yourself if you have not been trained how to do so. If you
are not sure what to do, talk to your doctor or nurse
immediately.

PP7/0986/V2

Before injecting yourself with Clexane
• Check the expiry date on the medicine. Do not use if the
date has passed
• Check the syringe is not damaged and the medicine in it
is a clear solution. If not, use another syringe
• Make sure you know how much you are going to inject
• Check your abdomen to see if the last injection caused
any redness, change in skin colour, swelling, oozing or is
still painful, if so talk to your doctor or nurse
• Decide where you are going to inject the medicine.
Change the place where you inject each time from the
right to the left side of your stomach. Clexane should be
injected just under the skin on your stomach, but not too
near the belly button or any scar tissue (at least 5 cm
away from these)
Instructions on injecting yourself with Clexane:
1) Wash your hands and the area that you will inject with
soap and water. Dry them.
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.
3) Choose an area on the right or
left side of your stomach. This
should be at least 5 centimetres
away from your belly button and out
towards your sides.
Remember: Do not inject yourself
within 5 centimetres of your belly button or around existing
scars or bruises. Change the place where you inject
between the left and right sides of your stomach,
depending on the area you were last injected.
4) Carefully pull off the needle cap from the Clexane
syringe. Throw away the cap. The syringe is pre-filled and
ready to use.

Do not press on the plunger before injecting yourself to get
rid of air bubbles. This can lead to a loss of the medicine.
Once you have removed the cap, do not allow the needle
to touch anything. This is to make sure the needle stays
clean (sterile).
5) Hold the syringe in the hand
you write with (like a pencil) and
with your other hand gently pinch
the cleaned area of your abdomen
between your forefinger and
thumb to make a fold in the skin.
Make sure you hold the skin fold
throughout the injection.

6) Hold the syringe so that
the needle is pointing
downwards (vertically at a
90° angle). Insert the full
length of the needle into
the skin fold.
7) Press down on the plunger with your thumb. This will
send the medication into the fatty tissue of the stomach.
Make sure you hold the skin fold throughout the injection.
8) Remove the needle by pulling it straight out. You can
now let go of the skin fold.
To avoid bruising, do not rub the injection site after
you have injected yourself.
9) Drop the used syringe at the needle end first into the
sharps bin provided. Close the container lid tightly and
place the container out of reach of children.
When the container is full, give it to your doctor or
home care nurse for disposal. Do not put it in the
household rubbish.
If you have too much or too little Clexane
If you think that you have used too much or too little
Clexane, tell your doctor, nurse or pharmacist immediately,
even if you have no signs of a problem. If a child
accidentally injects or swallows Clexane, take them to a
hospital casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as soon as you
remember. Do not give yourself a double dose on the
same day to make up for a forgotten dose. Keeping a
diary will help to make sure you do not miss a dose.
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. 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.
Frequency unknown
• If you have had a spinal puncture or a spinal anaesthetic
and notice tingling, numbness and muscular weakness,
particularly in the lower part of your body. Also if you
lose control over your bladder or bowel (so you cannot
control when you go to the toilet).
Tell a nurse or doctor as soon as possible if you notice
any of the following side-effects:
Common (affects 1 to 10 people in a 100)
• You bruise more easily than usual. This could be
because of a blood problem (thrombocytopenia).
• You have pain, swelling or irritation in the area you have
been injected with Clexane. This normally gets better
after a few days.
Rare (affects less than 1 in a 1000 people)
• If you have a mechanical heart valve, treatment with
Clexane might not be sufficient to prevent blood clots.
You may notice that you have difficulty breathing,
tiredness or difficulty exercising, chest pain, numbness,
feeling sick or loss of consciousness. This could be due
to a blood clot on the heart valve
Frequency unknown
• Feeling tired, faint, dizzy, having pale skin. These
could be symptoms of anaemia.
• You notice yellowing of your skin or eyes and your
urine becomes darker in colour. This could be a liver
problem.
Other side effects that you should discuss with your
nurse or doctor if you are concerned about them:
Very common (affects more than 1 in 10 people)
• Changes in the results of blood tests done to check how
your liver is working. These usually go back to normal
after you stop having Clexane.
Rare (affects less than 1 in 1000 people)
• Changes in the potassium levels in your blood. This is
more likely to happen in people with kidney problems
or diabetes. Your doctor will be able to check this by
carrying out a blood test.
Frequency unknown
• If Clexane is used for a long period of time (more than
3 months), it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your
bones are more likely to break.
• Headache
• Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store and dispose of Clexane
Keep out of the sight and reach of children.
Keep them in their box. Do not use after the expiry date
which is stated on the carton. The expiry date refers to the
last day of that month.
Do not keep your Injection if your doctor decides to stop
treatment.
Do not store above 25°C. Do not refrigerate or freeze.
Return them to your pharmacist who will arrange for their
safe disposal.
If your medicine shows any sign of discolouration or
deterioration consult your pharmacist for advice.
Remember these Injections are only for you. Only a doctor
may prescribe them for you. Never give them to other
people. They may harm other people even if their
symptoms appear the same as yours.
6. Further information
Clexane 80mg/0.8ml are single pre-filled syringes
containing a clear liquid, fitted with a needle and cap, with
a brick red plunger, contained in a plastic tray sealed with a
plastic paper seal.
Contains 80mg of enoxaparin sodium (Anti-factor Xa
activity 8,000 I.U.) as active ingredient in 0.8ml water for
injections; this is equivalent to 100mg per ml. The only
other ingredient is water for injection.
Clexane come in prefilled syringes which are packed into
boxes of 10.
This medicine is manufactured by Chinoin Pharmaceutical
and Chemical Works Private Co. Ltd., Miskolc, Csanyikvolgy,
Hungary. Procured from within the EU. Product Licence
holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by
Maxearn Ltd, Bolton BL6 4SA.
Clexane Syringes 80mg/0.8ml

PL 20774/0986

Clexane is a registered trademark of AVENTIS PHARMA
SA.
Date of preparation 5th February 2016

PP7/0986/V2

POM

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY

Clexane® Syringes 80mg/0.8ml
(enoxaparin sodium)
The following information is extracted from the SPC.
Technical information for the administration of Clexane Syringes

Your medicine is also available in 20mg, 40mg, 60mg and 100mg syringes.
1. NAME OF THE MEDICINAL PRODUCT
Clexane Syringes
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes
20 mg injection Enoxaparin sodium 20 mg (equivalent to 2,000 IU anti-Xa activity) in 0.2 mL
Water for Injections
40 mg injection Enoxaparin sodium 40 mg (equivalent to 4,000 IU anti-Xa activity) in 0.4 mL
Water for Injections
60 mg Injection Enoxaparin sodium 60 mg (equivalent to 6,000 IU anti-Xa activity) in 0.6 mL
Water for Injections
80mg Injection Enoxaparin sodium 80 mg (equivalent to 8,000 IU anti-Xa activity) in
0.8 mL Water for Injections
100mg injection Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0
mL Water for Injections
For full list of excipients, see section 6.1

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
Kg
Syringe Label
Dose (Mg)
Weight
40
40mg/0.4ml
40 bd
100mg/ml
45
60mg/0.6ml
45 bd
Solution for
50
60mg/0.6ml
50 bd
Injection
55
60mg/0.6ml
55 bd
CLEXANE
60
60mg/0.6ml
60 bd
syringes
65
80mg/0.8ml
65 bd
70
80mg/0.8ml
70 bd
75
80mg/0.8ml
75 bd
80
80mg/0.8ml
80 bd
85
100mg/1ml
85 bd
90
100mg/1ml
90 bd
95
100mg/1ml
95 bd
100
100mg/1ml
100 bd
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
Kg
Syringe Label
Dose (Mg)
Weight
105
120mg/0.8ml
105 bd
150mg/ml
110
120mg/0.8ml
110 bd
Solution for
115
120mg/0.8ml
115 bd
Injection
120
120mg/0.8ml
120 bd
CLEXANE Forte
125
150mg/1ml
125 bd
syringes
130
150mg/1ml
130 bd
135
150mg/1ml
135 bd
140
150mg/1ml
140 bd
150mg/1ml
145 bd
145
150
150mg/1ml
150 bd

Clear Liquid

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 1 mg/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.

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.

Patient
weight
100mg/ml
Solution for
Injection
Clexane
Syringes

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.

Patient
weight
150mg/ml
Solution
For Injection
CLEXANE
Forte
syringes

Injection
Volume (ml)
0.70
0.74
0.78
0.80
0.84
0.88
0.90
0.94
0.98
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.

3. Pharmaceutical form
Solution for Injection.

Patient
weight
100mg/ml
Solution
For Injection
CLEXANE
syringes

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

Patient
weight

Dosage chart for 1mg/kg SC treatment of STEMI
Kg
Syringe label
Dose
(mg)
40
40mg/0.4ml
40 bd
45
60mg/0.6ml
45 bd
50
60mg/0.6ml
50 bd
55
60mg/0.6ml
55 bd
60
60mg/0.6ml
60 bd
65
80mg/0.8ml
65 bd
70
80mg/0.8ml
70 bd
75
80mg/0.8ml
75 bd
80
80mg/0.8ml
80 bd
85
100mg/1ml
85 bd
90
100mg/1ml
90 bd
95
100mg/1ml
95 bd
100
100mg/1ml
100 bd

Dosage chart for 1mg/kg SC treatment of STEMI
Kg
Syringe label
Dose (mg)

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Kg
Syringe label
Dose (mg)
Injection volume (ml)
40
45
50

60mg/0.6ml
80mg/0.8ml
80mg/0.8ml

60 od
67.5 od
75 od

0.60
0.675
0.75

55
60
65

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

82.5 od
90 od
97.5 od

0.825
0.90
0.975

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Kg
Syringe label
Dose (mg)
Injection volume (ml)
70
75
80

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

105 od
112.5 od
120 od

0.70
0.76
0.80

85
90
95
100

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

127.5 od
135 od
142.5 od
150 od

0.86
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.

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 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.
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 1 mg/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 the 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
years only)
Patient
Kg
Syringe label
0.75mg/kg
weight
Dose (mg)
30 bd
40
60mg/0.6ml
45
60mg/0.6ml
33.75 bd
50
60mg/0.6ml
37.5 bd
60mg/0.6ml
41.25 bd
55
60
60mg/0.6ml
45 bd
65
60mg/0.6ml
48.75 bd
100mg/ml
70
60mg/0.6ml
52.5 bd
Solution for
75
60mg/0.6ml
56.25 bd
Injection
80
60mg/0.6ml
60 bd
CLEXANE
85
80mg/0.8ml
63.75 bd
syringes
90
80mg/0.8ml
67.5 bd
95
80mg/0.8ml
71.25 bd
100 80mg/0.8ml
75 bd
78.75 bd (1)
105 80mg/0.8ml
82.5 bd (1)
110 100mg/1ml
86.25 bd (1)
115 100mg/1ml
90 bd (1)
120 100mg/1ml
93.75 bd (1)
125 100mg/1ml
97.5 bd (1)
130 100mg/1ml
150mg/ml
101.25 bd (1)
135 120mg/0.8ml
Solution for
105 bd (1)
140 120mg/0.8ml
Injection
108.75 bd (1)
145 120mg/0.8ml
CLEXANE
112.5 bd (1)
150 120mg/0.8ml
Forte
syringes

(elderly patients aged ≥ 75
Adjusted
dosing (mg)
30 bd
35 bd
37.5 bd
42.5 bd
45 bd
50 bd
52.5 bd
57.5 bd
60 bd
65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)
82.5 bd (1)
87.5 bd (1)
90 bd (1)
95 bd (1)
97.5 bd (1)
102 bd (1)
105 bd (1)
111 bd (1)
114 bd (1)

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)

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).

(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.

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.

Children: Not recommended, as dosage not established.

Volume to be injected through intravenous line after dilution is completed.

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

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

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

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

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.
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.
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.

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% in dextrose in water.
6.3 Shelf life
See expiry date on carton
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 80mg/0.8ml are single pre-filled syringes containing a clear liquid, fitted with a
needle and cap, with a brick red plunger, contained in a plastic tray sealed with a paper
seal.
Clexane come in pre-filled syringes which are packed into 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
05.02.2016

PP3/0986/V3

Expand view ⇕

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.

Hide