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CLEXANE FORTE 150MG/ML SYRINGES

Active substance(s): ENOXAPARIN SODIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

i

reaction include: a rash,
swallowing or breathing problems,
swelling of your lips, face, throat
or tongue
The name of your medicine is Clexane
You are allergic to heparin or other
Forte 120mg/0.8ml Syringes or Clexane Forte
Low Molecular Weight Heparins such as
150mg/1ml Syringes (called Clexane Forte
tinzaparin or dalteparin
in this leaflet). Clexane Forte contains a
You have a problem with bruising or
medicine called enoxaparinsodium. This
bleeding too easily
belongs to a group of medicines called Low
(enoxaparin sodium)
You are bleeding heavily
Molecular Weight Heparins.
You have an ulcer in your stomach or gut
Information for other strengths of Clexane Clexane Forte works in two ways.

(intestine)
also may be present in this leaflet.
1) Stopping existing blood clots from getting
You
have had a stroke caused by bleeding
any bigger. This helps your body to break
Is this leaflet hard to see or read?

in
the
brain
them down and stop them causing you harm.
Phone +31 20 5616029 for help.
You
have
an infection in your heart
2) Stopping blood clots forming in your blood.
Read all of this leaflet carefully before
You are using the medicine called heparin
Clexane Forte can be used to:
you start using this medicine
to treat blood clots
• Keep this leaflet. You may need to read it again • Treat blood clots that are in your blood
Do not take this medicine if any of the
• If you have any further questions, ask your • Stop blood clots forming in your blood in above apply to you. If you are not sure,
the following situations:
doctor or pharmacist or nurse.
talk to your doctor, pharmacist or nurse
• This medicine has been prescribed for you. • Unstable angina (where not enough
before having Clexane Forte.
blood gets to your heart)
Do not pass it on to others. It may harm

Take special care with Clexane Forte
them, even if their symptoms are the same • After an operation or long periods of bed
Check with your doctor or pharmacist
rest due to illness
as yours

before having this medicine if:
• After you have had a heart attack
• If any of the side-effects get serious, or
▲ You have high blood pressure which is not
• Stop blood clots forming in the tubes of
if you notice any side effects not listed
controlled by medication
your dialysis machine (used for people
in this leaflet, please tell your doctor or
with kidney problems)
▲ You have kidney problems
pharmacist or nurse.

Clexane® Forte
120mg/0.8ml Syringes
Clexane® Forte
150mg/1ml Syringes

In this leaflet:
1. What Clexane Forte is and what it is used for
2. Before you use Clexane Forte
3. How to use Clexane Forte
4. Possible side-effects
5. How to store and dispose of Clexane Forte
6. Further information

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

2. Before you use Clexane Forte



Do not have this medicine and
tell your doctor if:

You are allergic (hypersensitive) to
enoxaparin sodium. Signs of an allergic








▲ 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
1

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Over

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

Clexane® Forte 120mg/0.8ml Syringes
Clexane® Forte 150mg/1ml 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 pre-operatively.
In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial
dose administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for cancer and are not otherwise at risk for major
bleeding complications, the recommended dosage is 40 mg (4,000 IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is
prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least
5 days and until adequate oral anticoagulation is established.
1

▲ You are a diabetic or have an illness known • Water tablets (diuretics) such as
as ‘diabetic retinopathy’ (problems with the spironolactone, triamterene or amiloride.
blood vessels in the eye caused by diabetes) These may increase the levels of potassium
in your blood when taken with Clexane
▲ You have any problems with your blood
• Streptokinase, alteplase and reteplase ▲ You are underweight or overweight
used to dissolve blood clots after a heart
▲ You are elderly (over 65 years old) and
attack
especially if you are aged over 75 years old
• Dextran injection - used to replace blood
If you are not sure if any of the above applies volume
to you, talk to your doctor or pharmacist or
• Ibuprofen, diclofenac, ketorolac or other
nurse before having Clexane Forte.
medicines used to treat pain and swelling
in arthritis and other illnesses
Taking or using other medicines
• Prednisolone, dexamethasone or other
steroid medicines - used to treat asthma,
Please tell your doctor, pharmacist or
rheumatoid arthritis and other conditions
nurse if you are taking or have recently
• Water tablets (diuretics) such as spironotaken any other medicines. This includes
lactone, triamterene or amiloride. These
medicines you buy without a prescription,
may increase the levels of potassium in
including herbal medicines. This is because
your blood when taken with Clexane Forte
Clexane Forte can affect the way some other
Your doctor may change one of your medicines
medicines work. Also some medicines can
or take regular blood tests to check that
affect the way Clexane Forte works.
taking these medicines with Clexane Forte is
In particular, do not take this
not causing you any harm.
medicine and tell your doctor if:
Operations and anaesthetics

You are using the medicine called
If you are going to have a spinal puncture
heparin to treat blood clots
or an operation where an epidural or
Tell your doctor if you are taking any
spinal anaesthetic is used, tell your doctor
of the following medicines:
that you are using Clexane Forte . Tell also
• Warfarin - used for thinning the blood
your doctor if you have any problem with
• Aspirin - used to stop blood clots from
your spine or if you have ever had spinal
forming. Aspirin may also be used for
surgery.
pain relief and in medicines for colds
Pregnancy and breast-feeding
and flu
• Dipyridamole, clopidogrel, or other medi- Talk to your doctor before you are given this
medicine if you are pregnant, might become
cines - used to stop blood clots forming
pregnant or think you may be pregnant.
• Prednisolone, dexamethasone or other
medicines - used to treat asthma,
You should not use this medicine if you are
rheumatoid arthritis and other conditions 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 breastfeed, 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 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
2


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

Patient
weight
100mg/ml
Solution for
Injection
CLEXANE
syringes

Dose (mg)

Injection
volume (ml)

Kg

Syringe label

40

60mg / 0.6ml

60 od

0.60

45
50
55
60
65

80mg / 0.8ml
80mg / 0.8ml

67.5 od
75 od

0.675
0.75

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

Patient
weight

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes

70
75
80
85
90
95
100

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

105 od
112.5 od
120 od

0.70
0.76
0.80

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

Patient
weight

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

100mg/ml
Solution for
Injection
CLEXANE
syringes

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

40mg / 0.4ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

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

0.40
0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00

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

Patient
weight

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes

105
110
115
120
125
130
135
140
145
150

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

105 bd
110 bd
115 bd
120 bd

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

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

0.70
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.
2

c) After you have had a heart attack
Clexane Forte can be used for two different
types of heart attack called NSTEMI or STEMI.
The amount of Clexane Forte given to you
will depend on your age and the kind of
heart attack you have had.
i) NSTEMI type of heart attack
• The usual amount is 1mg for every
kilogram of weight, every 12 hours

• 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
• Clexane Forte will usually be given for 2
5 days
to 8 days. Your doctor will normally ask

2) Stopping blood clots forming in your
you to take aspirin as well.
blood in the following situations:
ii) STEMI type of heart attack

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

If you are under 75 years old


b) After an operation or long periods of
bed rest due to illness
The usual dose is 20mg or 40mg each
day. The dose will depend on how likely
you are to develop a clot
• If you have a low to medium risk of
getting a clot, you will be given 20mg of
Clexane Forte each day for 7 to 10 days.
If you are going to have an operation,
your first injection will usually be given
2 hours before your operation
• If you have a higher risk of getting a clot,
you will be given 40mg each day for 7
to 28 days. If you are going to have an
operation, your first injection will usually
be given 12 hours before your operation
• If you are bedridden due to illness,
you will be normally be given 40mg of
Clexane Forte each day for 6 to 14 days

• 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, 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 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
3



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Over

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

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40mg / 0.4ml

40 bd

0.40

100mg/ml
Solution for
Injection
CLEXANE
syringes

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

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

45 bd
50 bd
55 bd
60 bd

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml

65 bd
70 bd
75 bd
80 bd
85 bd
90 bd
95 bd
100 bd

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

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

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)

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

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodium should be given between 15 minutes
before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as
having STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours
before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV
bolus of 0.3mg/kg of enoxaparin sodium should be administered (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled
syringes).
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If
fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a high
risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of age, do not use an initial IV bolus. Initiate dosing
with 0.75mg/kg SC every 12 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is impaired (see also section 4.2 Posology and
method of administration: Renal impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment,
3
and Monitoring; section 5.2 Pharmacokinetic properties).


















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 5 cm 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.


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

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 cm 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.

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.

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.

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.



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.



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).

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

4

Dosage chart for 0.75mg/kg SC treatment of STEMI (elderly patients aged ≥75 years only)
Patient weight

100mg/ml
Solution for 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
85
90
95
100
105
110
115
120
125
130
135
140
145
150

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

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

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

0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60
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)

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

63.75 bd
67.5 bd
71.25 bd
75 bd
78.75 bd (1)
82.5 bd (1)
86.25 bd (1)
90 bd (1)
93.75 bd (1)
97.5 bd (1)
101.25 bd (1)
105 bd (1)
108.75 bd (1)
112.5 bd (1)

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)

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)

4

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.
Note: the safety system allowing release of
the protective sleeve, can only be activated
when the syringe has been emptied by
pressing the plunger all the way down.
To avoid bruising, do not rub the injection
site after you have injected yourself.
9) Drop the used syringe with its protective
sleeve into the sharps bin provided. Close
the container lid tightly and place the
container out of reach of children.
When the container is full, give it to
your doctor or home care nurse for
disposal. Do not put it in the household
rubbish.
If you have too much or too little
Clexane Forte
If you think that you have used too much or
too little Clexane Forte , tell your doctor, nurse
or pharmacist immediately, even if you have
no signs of a problem. If a child accidentally
injects or swallows Clexane 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

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.
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.
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 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
Turn
Over
5

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. 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
5

consciousness. This could be due to a
blood clot on the heart valve
Frequency unknown
• Feeling tired, faint, dizzy, having pale skin.
These could be symptoms of anaemia.
• You notice yellowing of your skin or eyes
and your urine becomes darker in colour.
This could be a liver problem.
Other side effects that you should
discuss with your nurse or doctor if you
are concerned about them:
Very common (affects more than 1 in 10 people)
• Changes in the results of blood tests
done to check how your liver is working.
These usually go back to normal after
you stop having Clexane Forte.

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.

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.

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.

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

5. How to store and dispose of Clexane Forte
Keep this medicine 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. Store in the original packaging to protect
from light.

If the medicine becomes discoloured or shows
any other signs of deterioration, you should seek
the advice of your pharmacist who will tell you
what to do.

• Each pre-filled syringe contains 150mg of
enoxaparin sodium (equivalent to 15,000IU
anti-Xa activity), in 1ml water for injection
• 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
fitted with injection needle, rubber stopper and
an automatic safety device, it is supplied in packs
of 10 syringes. Each syringe is individually packed
in a transparent blister.
Procured from within the EU & repackaged
by Product Licence holder:
Originalis B.V.,
Joop Geesinkenweg 901,
1114 AB Amsterdam-Duivendrecht,
The Netherlands
Manufactured by
Sanofi Winthrop Industrie,
180 Rue Jean Jaures, B.P. 37,
94702 Maisons-Alfort Cedex, France.
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.
PL 45233/0010, PL 45233/0012
Clexane® Forte 120mg/0.8ml Syringes
PL 45233/0011, PL 45233/0013
Clexane® Forte 150mg/1ml Syringes

• Headache
• Hair loss

6. Further Information

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

What Clexane Forte contains

POM

• Each pre-filled syringe contains 120mg of
enoxaparin sodium (equivalent to 12,000IU
anti-Xa activity), in 0.8ml water for injection

Leaflet revision date: 03.06.2016
Clexane® is a registered trademark of
Aventis Pharma SA, France.


syringe into the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a

6

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)

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

Weight

Required dose
(0.3mg/kg)

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

(Kg)
45
50
55
60
65
70
75
80

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

(ml)
4.5

(Kg)
100

(mg)
30

5
5.5
6
6.5
7
7.5
8
8.5
9
9.5

105
110
115
120
125
130
135
140
145
150

31.5
33
34.5
36
37.5
39
40.5
42
43.5
45

(ml)
10
10.5
11
11.5
12
12.5
13
13.5

85
90
95

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

24 months
6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.
Store in the original packaging to protect from light.
6.5 Nature and contents of container

Solution for injection in Type I glass prefilled syringes fitted with injection needle and an automatic safety device in packs of 10.
6.6 Special precautions for disposal

See section 4.2 Posology and method of administration.
9




DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
PL 45233/0010, PL 45233/0011,
PL 45233/0012, PL 45233/0013
Date of first authorisation xx/xx/xxxx

10 Leaflet revision date: 03.06.2016

45233/0010/11/12/13_003

6

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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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