CLEXANE FORTE SYRINGES

Active substance: ENOXAPARIN SODIUM

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Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Article
Brand name Clexane Eris
Leaflet
Item code 520278
Dosage
120/150mg
Based on 519350
Quantity
10 SRG
GMID code 518769
Manuf. site
Maisons Alfort
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Date of creation
15/05/2013
By
F Nguyen
Date of modification 04/06/2013
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

N/A
TRA-P015644j
TRA-P015644-2a
210x315 TC

1. What Clexane Forte is and
what it is used for
The name of your medicine is Clexane
Forte 120mg or 150mg Pre-filled 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.

Is this leaflet hard to see or read?
Phone 01483 505515 for help
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.
In this leaflet:
1. hat Clexane Forte is and what it is used for
W
2. efore you use Clexane Forte
B
3. ow to use Clexane Forte
H
4. ossible side-effects
P
5. ow to store and dispose of Clexane Forte
H
6. urther information
F

Clexane Forte works in two ways:
1) Stopping existing blood clots from
getting any bigger. This helps your body to
break them down and stop them causing
you harm.
2) Stopping blood clots forming in your
blood.
Clexane Forte can be used to:
• Treat blood clots that are in your blood
• Stop blood clots forming in your blood
in the following situations:
• Unstable angina (where not enough
blood gets to your heart)
• After an operation or long periods of
bed rest due to illness
• After you have had a heart attack
• Stop blood clots forming in the tubes
of your dialysis machine (used for
people with kidney problems)
2. Before you use Clexane Forte
Do not have this medicine and
tell your doctor if:

Datamatrix
Brandmark/name
Country example
Font size

520278
A1 - 13.03.2006
CRGB - V1 - 05/2012
9 pt
Plan

You are allergic (hypersensitive) 520278
to enoxaparin sodium. Signs of 518769
an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or
tongue
You are allergic to heparin or other
Low Molecular Weight Heparins such as
tinzaparin or dalteparin
You have a problem with bruising or
bleeding too easily
You are bleeding heavily
You have an ulcer in your stomach or
gut (intestine)
You have had a stroke caused by
bleeding in the brain
You have an infection in your heart
You are using the medicine called
heparin to treat blood clots
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


THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

1
520278
518769

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 E noxaparin sodium 120 mg (equivalent to 12,000 IU anti-Xa activity) in 0.8 mL Water for Injections
150 mg Injection E noxaparin 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.
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

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Article
Brand name Clexane Eris
Leaflet
Item code 520278
Dosage
120/150mg
Based on 519350
Quantity
10 SRG
GMID code 518769
Manuf. site
Maisons Alfort
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

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.
In particular, do not take this medicine
and tell your doctor if:
You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any
of the following medicines:
• Warfarin - used for thinning the blood
• Aspirin - used to stop blood clots from
forming. Aspirin may also be used for
pain relief and in medicines for colds
and flu

Date of creation
15/05/2013
By
F Nguyen
Date of modification 04/06/2013
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

N/A
TRA-P015644j
TRA-P015644-2a
210x315 TC

Datamatrix
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Country example
Font size

520278
A1 - 13.03.2006
CRGB - V1 - 05/2012
9 pt
Plan

• Dipyridamole, clopidogrel, or other
medicines - used to stop blood clots
forming
• Streptokinase, alteplase and reteplase
- used to dissolve blood clots after a
heart attack
• Dextran injection - used to replace
blood volume
• Ibuprofen, diclofenac, ketorolac or
other medicines used to treat pain and
swelling in arthritis and other illnesses
• Prednisolone, dexamethasone or
other steroid medicines - used to treat
asthma, rheumatoid arthritis and
other conditions
• Water tablets (diuretics) such as
spironolactone, triamterene or
amiloride. These may increase the
levels of potassium in your blood
when taken with Clexane Forte
Your doctor may change one of your
medicines or take regular blood tests to
check that taking these medicines with
Clexane Forte is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture
or an operation where an epidural or
spinal anaesthetic is used, tell your doctor
that you are using Clexane Forte. Tell also
your doctor if you have any problem with
your spine or if you have ever had spinal
surgery.
Pregnancy and breast-feeding
Talk to your doctor before you are given
this medicine if you are pregnant, might
become pregnant or think you may be

pregnant.
You should not use this medicine if you
are pregnant and have a mechanical heart
valve as you may be at increased risk of
developing blood clots. Your doctor should
discuss this with you.
You should not breast-feed whilst using
Clexane Forte. If you are planning to breastfeed, 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)
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.

2


Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
Injection
Kg
Syringe label Dose (mg)
weight
volume (ml)
100mg/ml
Solution for
Injection
CLEXANE
syringes

40
45
50
55
60
65

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

60 od
67.5 od
75 od
82.5 od
90 od
97.5 od

0.60
0.675
0.75
0.825
0.90
0.975

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
Injection
Kg
Syringe label Dose (mg)
weight
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
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

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

0.70
0.76
0.80
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 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
Injection
Kg
Syringe label Dose (mg)
weight
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
Injection
Kg
Syringe label Dose (mg)
weight
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
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

105 bd
110 bd
115 bd
120 bd
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

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Article
Brand name Clexane Eris
Leaflet
Item code 520278
Dosage
120/150mg
Based on 519350
Quantity
10 SRG
GMID code 518769
Manuf. site
Maisons Alfort
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

Date of creation
15/05/2013
By
F Nguyen
Date of modification 04/06/2013
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

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

PAD
Tech. specif.
Tech. area
Size (mm)

N/A
TRA-P015644j
TRA-P015644-2a
210x315 TC

Datamatrix
Brandmark/name
Country example
Font size

520278
A1 - 13.03.2006
CRGB - V1 - 05/2012
9 pt
Plan

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 10 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
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) TEMI type of heart attack
S
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 520278
for every kilogram of your 518769
weight every 12 hours after that
• The maximum amount of Clexane
given for the first two injections is
100mg
• The injections will normally be given
for up to 8 days
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) Stop 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

3
520278
Treatment of acute ST-segment Elevation Myocardial Infarction
518769
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.



Patient
weight

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

Patient
weight

Dosage chart for 1mg/kg SC treatment of STEMI
Injection
Kg
Syringe label
Dose (mg)
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 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).
3

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Article
Brand name Clexane Eris
Leaflet
Item code 520278
Dosage
120/150mg
Based on 519350
Quantity
10 SRG
GMID code 518769
Manuf. site
Maisons Alfort
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

Date of creation
15/05/2013
By
F Nguyen
Date of modification 04/06/2013
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

N/A
TRA-P015644j
TRA-P015644-2a
210x315 TC

Datamatrix
Brandmark/name
Country example
Font size

520278
A1 - 13.03.2006
CRGB - V1 - 05/2012
9 pt
Plan

belly button or any scar tissue (at least
• This amount is usually enough for a
5cm away from these)
4 hour session. However, your doctor
may give you a further dose of 0.5 to
1mg for every kilogram of your weight Instructions on injecting yourself with
Clexane Forte:
if necessary
Children
1) Wash your hands and the area that you
This medicine should not be given to
will inject with soap and water. Dry
children.
them.
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.
2) Sit or lie in a comfortable position so you
Before injecting yourself with Clexane
are relaxed. Make sure you can see the
Forte
place you are going to inject. A lounge
• Check the expiry date on the medicine.
chair, recliner, or bed propped up with
Do not use if the date has passed
pillows is ideal.
• 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
3) Choose an area on the right or left side
in skin colour, swelling, oozing or is still
of your stomach. This should be at least
painful. If so talk to your doctor or nurse
5 centimetres away from your belly
• Decide where you are going to inject the
button and out towards your sides.
medicine. Change the place where you Remember: Do not inject yourself
inject each time from the right to the
within 5cm of your belly button or
left side of your stomach. Clexane Forte
around existing scars or bruises. Change
should be injected just under the skin
the place where you inject between the
on your stomach, but not too near 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.

Make sure you hold the skin fold
throughout the injection.
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
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

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

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

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)

0.65
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)

(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:

Standard dosing

Dosage adjustments for therapeutic dosage range
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

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Article
Brand name Clexane Eris
Leaflet
Item code 520278
Dosage
120/150mg
Based on 519350
Quantity
10 SRG
GMID code 518769
Manuf. site
Maisons Alfort
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

Date of creation
15/05/2013
By
F Nguyen
Date of modification 04/06/2013
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

N/A
TRA-P015644j
TRA-P015644-2a
210x315 TC

Datamatrix
Brandmark/name
Country example
Font size

520278
A1 - 13.03.2006
CRGB - V1 - 05/2012
9 pt
Plan

6) Hold the syringe so that the needle 9) Drop the used syringe with its protective 4. Possible side effects
sleeve into the sharps bin provided. Close
is pointing downwards (vertically at a
the container lid tightly and place the Like all medicines, Clexane Forte can cause
90º angle). Insert the full length of the
side-effects, although not everybody gets
container out of reach of children.
needle into the skin fold.
them.
7) Press down on the plunger with your When the container is full, give it to
finger. This will send the medication into your doctor or home care nurse for Tell a nurse or doctor or go to hospital
the fatty tissue of the stomach. Make disposal. Do not put it in the household straight away if you notice any of the
following side-effects:
sure you hold the skin fold throughout rubbish.
the injection.
If you have too much or too little Very common (affects more than 1 in 10
people)
Clexane Forte
If you think that you have used too much • Bleeding a lot from a wound.
or too little Clexane Forte, tell your doctor, Common (affects 1 to 10 people in a 100)
nurse or pharmacist immediately, even if • A painful rash of dark red spots under the
you have no signs of a problem. If a child
skin which do not go away when you put
accidentally injects or swallows Clexane
pressure on them. You may also notice
Forte, take them to a hospital casualty
pink patches on your skin. These are
department straight away.
more likely to appear in the area you
8) Remove the needle by pulling it straight
have been injected with Clexane Forte.
out. A protective sleeve will automatically If you forget to use Clexane Forte
Uncommon (affects 1 to 10 people in a
cover the needle. You can now let go of If you forget to give yourself a dose, have
it as soon as you remember. Do not give 1,000)
the skin fold.
yourself a double dose on the same day • Sudden severe headache. This could be a
sign of bleeding in the brain.
to make up for a forgotten dose. Keeping
a diary will help to make sure you do not • A feeling of tenderness and swelling in
your stomach. You may have bleeding
miss a dose.
inside your stomach.
If you stop using Clexane Forte
It is important for you to keep having Rare (affects less than 1 in a 1000 people)
Clexane Forte injections until your doctor • If you have an allergic reaction. The
signs may include: a rash, swallowing
decides to stop them. If you stop, you
or breathing problems, swelling of your
Note: the safety system allowing release could get a blood clot which can be very
lips, face, throat or tongue.
of the protective sleeve can only be dangerous.
• If you have had a spinal puncture or a
activated when the syringe has been
spinal anaesthetic and notice tingling,
emptied by pressing the plunger all the Blood Tests
Using Clexane Forte may affect the results
numbness and muscular weakness,
way down.
of some blood tests. If you are going to
particularly in the lower part of your
To avoid bruising, do not rub the
have a blood test, it is important to tell
body. Also if you lose control over your
injection site after you have injected
your doctor you are having Clexane Forte.
yourself.
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.
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 accidental needle stick after injection, the prefilled syringes are fitted with an automatic safety device
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be administered when the patient is lying down by deep subcutaneous
injection. The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall. The whole length of
the needle should be introduced vertically into a skin fold held between the thumb and index finger. The skin fold should not be released until the
injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects the used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection technique (for acute STEMI indication only)
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be used. Enoxaparin sodium should be
administered through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of
enoxaparin sodium with all other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior
to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered
with normal saline solution (0.9%) or 5% dextrose in water.
• Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or 100mg), expel the excessive volume to retain only 30mg
(0.3ml) in the syringe. The 30mg dose can then be directly injected into an injection site in the intravenous line.
• Additional bolus for PCI when last SC administration was given more than 8 hours before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3mg/kg is to be administered if last SC
administration was given more than 8 hours before balloon inflation (see section 4.2 Posology and method of administration: Treatment of acute
ST-segment Elevation Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to use a 50ml infusion bag (i.e. using either
normal saline solution (0.9%) or 5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60mg enoxaparin sodium prefilled
syringe into the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for
administration into the intravenous line (using an appropriate injection site or port).
5

Packaging Administration
Sanofi Winthrop Industrie - Le Trait - France
Article
Brand name Clexane Eris
Leaflet
Item code 520278
Dosage
120/150mg
Based on 519350
Quantity
10 SRG
GMID code 518769
Manuf. site
Maisons Alfort
Country
UK (Sale)
This artwork proof indicates colour position only.
Please refer to Pantone Colour Formula Guide 1000 for exact references

Date of creation
15/05/2013
By
F Nguyen
Date of modification 04/06/2013
By
F Nguyen
Proof n°
2
Pantone
Colours
used: 1
Reflex Blue

PAD
Tech. specif.
Tech. area
Size (mm)

N/A
TRA-P015644j
TRA-P015644-2a
210x315 TC

Datamatrix
Brandmark/name
Country example
Font size

520278
A1 - 13.03.2006
CRGB - V1 - 05/2012
9 pt
Plan

bladder or bowel (so you cannot control Frequency unknown
when you go to the toilet).
• If Clexane Forte is used for a long period
of time, it may increase the risk of you
Tell a nurse or doctor as soon as possible
getting a condition called ‘osteoporosis’.
if you notice any of the following side
This is when your bones are more likely
effects:
to break.
Common (affects 1 to 10 people in a 100)
• You bruise more easily than usual. This Reporting of side effects
could be because of a blood problem If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
(thrombocytopenia).
any possible side effects not listed in this
• You have pain, swelling or irritation in
the area you have been injected with leaflet. You can also report side effects
Clexane Forte. This normally gets better directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
after a few days.
By reporting side effects you can help
Rare (affects less than 1 in a 1000 people) provide more information on the safety of
• If you have a mechanical heart valve, this medicine.
treatment with Clexane Forte might
not be sufficient to prevent blood clots. 5. How to store and dispose of Clexane Forte
You may notice that you have difficulty
breathing, tiredness or difficulty Keep this medicine in a safe place where
exercising, chest pain, numbness, feeling children cannot see or reach it.
sick or loss of consciousness. This could Do not use Clexane Forte after the expiry
be due to a blood clot on the heart valve date which is stated on the syringe label
Other side effects that you should and on the box. The expiry date refers to
discuss with your nurse or doctor if you the last day of that month.
are concerned about them:
Store below 25°C. Do not store in a
Very common (affects more than 1 in 10 refrigerator or freezer. Store in the original
container.
people)
• Changes in the results of blood tests done Medicines should not be disposed of via
to check how your liver is working. These wastewater or household waste. If you are
usually go back to normal after you stop using this medicine at home you will be
having Clexane Forte.
given a container (a sharps bin) to use for
Rare (affects less than 1 in a 1000 people) disposal. Return the sharps bin or any used
• Changes in the potassium levels in your or unused syringes to your doctor or nurse
blood. This is more likely to happen in or pharmacist for disposal. These measures
people with kidney problems or diabetes. will help to protect the environment.
Your doctor will be able to check this by
6. Further information
carrying out a blood test.

520278
What Clexane Forte contains
518769
• Each 120mg pre-filled syringe
contains 120mg (12,000 IU antiXa activity) of the active substance,
enoxaparin sodium in 0.8ml
• Each 150mg pre-filled syringe contains
150mg (15,000 IU anti-Xa activity) of the
active substance, enoxaparin sodium 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 solution in a
Type I glass pre-filled syringe fitted with
an injection needle and needle cap. It is
supplied in packs of 2, 10 and 20 syringes.
Not all pack sizes may be marketed.
Marketing Authorisation
Holder and Manufacturer
Marketing Authorisation Holder
Sanofi,
One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515 - Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer
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.
This leaflet was last revised in 06/2013.
© sanofi, 2013

6
520278
After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution 518769
(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

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

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

6

Required dose
(0.3mg/kg)
(mg)
13.5
15
16.5
18
19.5
21
22.5
24
25.5
27
28.5

(ml)
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5

Weight
(Kg)
100
105
110
115
120
125
130

135
140
145
150

Required dose
(0.3mg/kg)

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

(mg)
30
31.5
33
34.5
36
37.5
39
40.5

(ml)
10
10.5
11
11.5
12
12.5
13
13.5

42
43.5
45

14
14.5
15

PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% 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.
Clexane prefilled syringes are single dose containers - discard any unused product.
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 2, 10 and 20.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration
9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 16 December 1999
Date of latest renewal: 4 February 2009
10 DATE OF REVISION OF THE TEXT
10/2011
6

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.

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