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CLEXANE FORTE 150MG/1ML PREFILLED SYRINGES

Active substance(s): ENOXAPARIN SODIUM

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Package Leaflet: Information for the User

CLEXANE® Forte 120 mg/0.8 ml
Prefilled Syringes
CLEXANE® Forte 150 mg/1 ml
Prefilled Syringes
(enoxaparin sodium)
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.
• Clexane Forte is also available in other
strengths.
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

In particular, do not take this medicine and
tell your doctor if
X 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

1. What Clexane Forte is and what it is used for

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.

The name of your medicine is Clexane Forte
120mg/0.8ml or Clexane Forte 150mg/1ml
Syringes (called Clexane Forte in this leaflet).
Clexane Forte contains a medicine called
enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight
Heparins.

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.

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.

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.

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:
X 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
X You are allergic to heparin or other Low
Molecular Weight Heparins such as tinzaparin
or dalteparin
X You have a problem with bruising or bleeding
too easily
X You are bleeding heavily
X You have an ulcer in your stomach or gut
(intestine)
X You have had a stroke caused by bleeding in
the brain
X You have an infection in your heart
X You are using the medicine called heparin to
treat blood clots
Do not take this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having
Clexane Forte.
Take special care with Clexane Forte
Check with your doctor or pharmacist before
having this medicine if:
 You have high blood pressure which is not
controlled by medication
 You have kidney problems
 You have had a heart valve fitted
 You have ever had bruising and bleeding
caused by the medicine heparin
 You have ever had a stroke
 You have ever had a stomach ulcer
 You have recently had an operation on your
eyes or brain
 You are a diabetic or have an illness known
as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by
diabetes)
 You have any problems with your blood
 You are underweight or overweight
 You are elderly (over 65 years old) and
especially if you are aged over 75 years old
If you are not sure if any of the above applies to
you, talk to your doctor, pharmacist or nurse
before having Clexane Forte.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Clexane Forte can
affect the way some other medicines work. Also
some medicines can affect the way Clexane
Forte works.

You should not use this medicine if you are
pregnant and have a mechanical heart valve as
you may be at increased risk of developing
blood clots. Your doctor should discuss this with
you.
You should not breast-feed whilst using Clexane
Forte. If you are planning to breast-feed, talk to
your doctor, pharmacist or nurse.
Ask your doctor, pharmacist or nurse for advice
before taking any medicine if you are pregnant
or breast-feeding.
3. How to use Clexane Forte

Having this medicine
Before you have Clexane Forte your doctor or
nurse may carry out a blood test
• While you are in hospital your doctor or
nurse will normally give you Clexane
Forte. This is because it needs to be
given as an injection
• When you go home you may need to
continue to use Clexane Forte and give it
to yourself (see below instructions on how
to do this)
• Clexane Forte is usually given by injection
underneath the skin (subcutaneous)
• Do not inject Clexane Forte into a muscle
(intramuscular)
If you are not sure why you are receiving
Clexane Forte or have any questions about how
much Clexane Forte is being given to you,
speak to your doctor, pharmacist or nurse.
How much will be given to you in hospital
• Your doctor will decide how much to give
you. The amount of Clexane Forte given to
you will depend on the reason it is being
used
• If you have problems with your kidneys, you
may be given a smaller amount of Clexane
Forte
Adults including the elderly
1) Treating blood clots that are in your
blood
• The usual dose is 1.5mg for every kilogram
of your weight, each day
• Clexane Forte will usually be given for at
least 5 days
2) Stopping blood clots forming in your
blood in the following situations:
a) Unstable angina
• The usual dose is 1mg for every kilogram of
your weight, every 12 hours
• Clexane Forte will usually be given for 2 to
8 days. Your doctor will normally ask you to
take aspirin as well
b) After an operation or long periods of bed
rest due to illness
The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are
to develop a clot.
• If you have a low to medium risk of getting a
clot, you will be given 20mg of Clexane
Forte each day for 7 to 10 days. If you are
going to have an operation, your first
injection will usually be given 2 hours before
your operation
• If you have a higher risk of getting a clot,
you will be given 40mg each day for 7 to 28
days. If you are going to have an operation,
your first injection will usually be given 12
hours before your operation
• If you are bedridden due to illness, you will
normally be given 40mg of Clexane Forte
each day for 6 to 14 days

c) After you have had a heart attack
Clexane can be used for two different types
of heart attack called NSTEMI or STEMI.
The amount of Clexane given to you will
depend on your age and the kind of heart
attack you have had.
i) NSTEMI type of heart attack
• The usual amount is 1mg for every kilogram
of weight, every 12 hours
• Clexane will usually be given for 2 to 8
days. Your doctor will normally ask you to
take aspirin as well.
ii) STEMI type of heart attack
If you are under 75 years old
• 30mg of Clexane will be given as an
injection into your vein (intravenous
injection using Clexane Multidose Vial or
60, 80 or 100mg Pre-filled syringes)
• At the same time, you will also be given
Clexane as an injection under your skin
(subcutaneous injection). The usual dose is
1mg for every kilogram of your weight.
• Then you will be given 1mg for every
kilogram of your weight every 12 hours
• The maximum amount of Clexane given for
the first two injections is 100mg
• The injections will normally be given for up
to 8 days
If you are aged 75 years or older
• Your doctor or nurse will give you injections
of Clexane Forte under your skin
(subcutaneous injection)
• The usual dose is 0.75mg for every
kilogram of your weight, every 12 hours
• The maximum amount of Clexane given for
the first two injections is 75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
• Depending on when you were last given
Clexane Forte, your doctor may decide to
give an additional dose of Clexane before a
PCI operation. This is by injection into your
vein (intravenous using Clexane Multidose
Vial or 60, 80 or 100mg Pre-filled Syringes).
3)






Stopping blood clots forming in the
tubes of your dialysis machine
The usual dose is 1mg for every kilogram of
your weight
Clexane Forte is added to the tube leaving
the body (arterial line) at the start of the
dialysis session
This amount is usually enough for a 4 hour
session. However, your doctor may give
you a further dose of 0.5 to 1mg for every
kilogram of your weight if necessary

Children
This medicine should not be given to children.
How to give yourself an injection of Clexane
Forte
If you are able to give Clexane Forte to yourself,
your doctor or nurse will show you how to do
this. Do not try to inject yourself if you have not
been trained how to do so. If you are not sure
what to do, talk to your doctor or nurse
immediately.
Before injecting yourself with Clexane Forte
• Check the expiry date on the medicine.
Do not use if the date has passed
• Check the syringe is not damaged and the
medicine in it is a clear solution. If not, use
another syringe
• Make sure you know how much you are
going to inject
• Check your abdomen to see if the last
injection caused any redness, change in skin
colour, swelling, oozing or is still painful. If so
talk to your doctor or nurse
• Decide where you are going to inject the
medicine. Change the place where you inject
each time from the right to the left side of
your stomach. Clexane Forte should be
injected just under the skin on your stomach,
but not too near the belly button or any scar
tissue (at least 5cm away from these)
Instructions on injecting yourself with
Clexane Forte:
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
5cm of your belly button or around existing
scars or bruises. Change the place where
you inject between the left and right sides of
your stomach, depending on the area you
were last injected.

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

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

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.

Manufactured by Sanofi Winthrop Industrie,
180 Rue Jean Jaures, 94 702 Maisons-Alfort,
France.

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.

PL Number:
39467/0265 CLEXANE Forte 120 mg/0.8 ml
Prefilled Syringes
PL Number:
39467/0266 CLEXANE Forte 150 mg/1 ml
Prefilled Syringes

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
Forte. This normally gets better after a few
days.
Rare (affects less than 1 in a 1000 people)
• If you have a mechanical heart valve,
treatment with Clexane Forte might not be
sufficient to prevent blood clots. You may
notice that you have difficulty breathing,
tiredness or difficulty exercising, chest pain,
numbness, feeling sick or loss of
consciousness. This could be due to a blood
clot on the heart valve

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.

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.

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.

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

Make sure you hold the skin fold throughout
the injection.

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.

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

Frequency unknown
• If Clexane Forte is used for a long period of
time (more than 3 months), it may increase
the risk of you getting a condition called
‘osteoporosis’. This is when your bones are
more likely to break.
• Headache
• Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store and dispose of Clexane Forte
• Keep out of the sight and reach of children.
• Do not use Clexane Forte after the expiry
date which is stated on the syringe label and
on the box. The expiry date refers to the last
day of that month.
• Do not store above 25°C. Do not refrigerate or
freeze.
• If your syringes become discoloured or show
any signs of deterioration, return them to
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

4. Possible side effects
Like all medicines, Clexane Forte can cause
side-effects, although not everybody gets them.
Tell a nurse or doctor or go to hospital
straight away if you notice any of the
following side-effects:
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.

What Clexane Forte contains
• Each 120mg pre-filled syringe contains
120mg enoxaparin sodium (12,000 IU antiXa activity) in 0.8ml.
• Each 150mg pre-filled syringe contains
150mg enoxaparin sodium (15,000 IU antiXa activity) in 1.0ml.
• The other ingredient is water for injections.
What Clexane Forte looks like and contents
of the pack
Clexane Forte is a clear, colourless to pale
yellow solution for injection in a glass pre-filled
syringe contained within individual sealed
blisters contained within printed carton(s).
It is supplied in packs of 10 syringes.

Procured from within the EU and Repackaged
by PilsCo Ltd, 10-16 Colvilles Place,
East Kilbride, Glasgow, G75 0SN.

Leaflet dated 07.07.2016
Clexane® is a registered trademark of Aventis
Pharma S.A.

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
CLEXANE® Forte 120 mg/0.8 m Prefilled Syringes
CLEXANE® Forte 150 mg/1 ml Prefilled Syringes
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
1 NAME OF THE MEDICINAL PRODUCT
Clexane® Forte Syringes
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.
150 mg Injection Enoxaparin sodium 150 mg (equivalent to 15,000 IU anti-Xa activity) in 1.0 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.
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 preoperatively.
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

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

Patient
weight

Patient
weight

100mg/ml
Solution
for
Injection
CLEXANE
syringes

Kg

Injection
Syringe label Dose (mg) 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
60
65

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

82.5 od
90 od
97.5 od

0.825
0.90
0.975

150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

70

120mg / 0.8ml

105 od

0.70

75
80

120mg / 0.8ml
120mg / 0.8ml

112.5 od
120 od

0.76
0.80

85

150mg / 1ml

127.5 od

0.86

90
95
100

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

135 od
142.5 od
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 325 mg 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

Kg

Syringe label Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

45

60mg / 0.6ml

45 bd

0.45

50
55
60

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

50 bd
55 bd
60 bd

0.50
0.55
0.60

65

80mg / 0.8ml

65 bd

0.65

70
75
80

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

70 bd
75 bd
80 bd

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

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

Injection
volume (ml)

Kg

Syringe label Dose (mg)

105

120mg / 0.8ml

105 bd

0.70

110
115
120

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

110 bd
115 bd
120 bd

0.74
0.78
0.80

150mg / 1ml

125 bd

0.84

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

130 bd
135 bd
140 bd
145 bd
150 bd

0.88
0.90
0.94
0.98
1.00

150mg/ml
Solution for
Injection
125
CLEXANE
Forte
130
syringes
135
140
145
150

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in
this table have been rounded up to the nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes)
plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining
doses). For dosage in patients ≥75 years of age, see section 4.2 Posology and method of administration: Elderly.
Dosage chart for 1mg/kg SC treatment of STEMI

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

100mg/ml
Solution for
Injection
CLEXANE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

45

60mg / 0.6ml

45 bd

0.45

50
55
60

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

50 bd
55 bd
60 bd

0.50
0.55
0.60

65

80mg / 0.8ml

65 bd

0.65

70
75
80

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

70 bd
75 bd
80 bd

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

Patient
weight

Kg

105
110
115
120
150mg/ml
Solution for
Injection
CLEXANE 125
Forte
130
syringes
135
140
145
150

Syringe label

Injection
Dose (mg) volume (ml)

105 bd (1)

0.70 (1)

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

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

150mg / 1ml (1) 125 bd (1)

0.84 (1)

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

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

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

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

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses) Please be aware that in
some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been
rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodium should be given between 15 minutes before and
30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained
under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon
inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin
sodium should be administered (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes).
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings
are found, such as after a longer than normal session, a further dose of 0.5 to 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 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).

(elderly patients aged ≥75 years only)

Dosage chart for 0.75mg/kg SC treatment of STEMI
Patient weight

100mg/ml
Solution for Injection
Injection
CLEXANE
syringes

150mg/ml Solution for
Injection
CLEXANE Forte syringes

Kg

Syringe label

0.75mg/kg Dose
(mg)

Adjusted
dosing (mg)

Injection volume
(ml)

40
45
50
55
60
65
70
75
80

60mg / 0.6ml

30 bd

30 bd

0.30

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

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

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

0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60

85

80mg / 0.8ml

63.75 bd

65 bd

0.65

90
95
100

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

67.5 bd
71.25 bd
75 bd
78.75 bd (1)

67.5 bd
72.5 bd
75 bd
80 bd (1)

0.675
0.725
0.75
0.80 (1)

105
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.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment and Monitoring; section 5.2 Pharmacokinetic properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min), according to the following tables, since enoxaparin
sodium exposure is significantly increased in this patient population:
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 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)

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)

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.
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 (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes).
It must not be administered by the intramuscular route. To avoid accident 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
(Kg)

Required dose
(0.3mg/kg)
(mg)

Volume to inject when diluted
to a final concentration of
(ml)

Weight
(Kg)

Required
dose
(mg)

Volume to inject when diluted
to a final concentration of
(ml)

45

13.5

4.5

100

30

10

50

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

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections.
6.2 Incompatibilities Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
6.3 Shelf life
Do not use Clexane Forte after the expiry date which is stated on the syringe label and on the box. The expiry date refers to the last day of that month.
6.4 Special precautions for storage
Do not store above 25oC. Do not refrigerate or freeze. Keep out of the sight and reach of children.
Clexane Forte prefilled syringes are single dose containers – discard any unused product.
6.5 Nature and contents of container
Clexane Forte comes in glass pre-filled syringes contained within individual sealed blister, blisters contained within printed carton(s). Clexane Forte Syringes are a
clear, colourless to pale yellow solution for injection and 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
07.07.2016

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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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