CLEXANE 60 MG/0.6 ML SYRINGES

Active substance: ENOXAPARIN SODIUM

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503996/PL1b

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Clexane® 60 mg/0.6 ml Syringes
(enoxaparin sodium)
This product is available in other strengths.

Is this leaflet hard to see or read?
Phone 01622 693000 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 or pharmacist
• This medicine has been prescribed for you.
Do not pass it onto others. It may harm
them, even if their symptoms are the same
as yours
• If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side-effects
5. How to store Clexane
6. Further information

1. What Clexane is
and what it is used for
The name of your medicine is Clexane
60 mg/0.6 ml Syringes (called Clexane in this
leaflet). Clexane contains a medicine
called enoxaparin sodium. This belongs to
a group of medicines called Low Molecular
Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting
any bigger. This helps your body to break
them down and stop them causing you
harm.
2) Stopping blood clots forming in your blood.
Clexane can be used to:
• Treat blood clots that are in your blood
• Stop blood clots forming in your blood in
the following situations:
• Unstable angina (where not enough
blood gets to your heart)
• After an operation or long periods of bed
rest due to illness
• After you have had a heart attack
• Stop blood clots forming in the tubes of
your dialysis machine (used for people
with kidney problems)

You are allergic (hypersensitive)
to enoxaparin sodium or any of
the other ingredients of Clexane (listed in
Section 6: Further information)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
You are allergic to heparin or other
Low Molecular Weight Heparins such as
tinzaparin or dalteparin
You have a problem with bruising or
bleeding too easily
You have an ulcer in your stomach or gut
(intestine)
You have had a stroke caused by bleeding
in the brain
You have an infection in your heart
You are using the medicine called heparin
to treat blood clots
Do not have this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor, pharmacist or nurse
before having Clexane.
Take special care with Clexane
Check with your doctor or pharmacist or
nurse before using this medicine if:
You have high blood pressure
You have kidney problems

2. Before you use Clexane
Do not have this medicine and tell
your doctor, pharmacist or nurse if:

You have had a heart valve fitted
You have ever had bruising and bleeding
caused by the medicine ‘heparin’

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

Clexane 60 mg/0.6 ml Syringes
enoxaparin sodium
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes

1

This product is available in other strengths.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Pre-filled syringes:
60 mg Injection Enoxaparin Sodium 60 mg (equivalent to 6,000 IU anti-Xa activity) in 0.6 mL Water for Injections
For full list of excipients, see section 6.1

3

• Dextran injection - used as a blood
replacer
• Ibuprofen, diclofenac, ketorolac or
other medicines - used to treat pain
and swelling in arthritis and other
illnesses
• Prednisolone,
dexamethasone
or
other medicines - used to treat
asthma,
rheumatoid
arthritis
and
other conditions
• Water tablets (diuretics) such as
spironolactone, triamterene or amiloride.
These may increase the levels of potassium
in your blood when taken with Clexane

You should not breast-feed whilst using
Clexane. If you are planning to breast-feed,
talk to your doctor, pharmacist or nurse.

Your doctor may change one of your
medicines or take regular blood tests to check
that taking these medicines with Clexane is
not causing you any harm.

• While you are in hospital your doctor or
nurse will normally give you Clexane. This is
because it needs to be given as an injection

You have ever had a stomach ulcer
You have recently had an operation on
your eyes or brain
You are a diabetic or have an illness known
as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and
especially if you are aged over 75 years old
If you are not sure if any of the above
applies to you, talk to your doctor or
pharmacist or nurse before using Clexane.
Taking or using other medicines
Please tell your doctor, pharmacist or
nurse if you are taking or have recently
taken any other medicines. This includes
medicines you buy without a prescription,
including herbal medicines. This is because
Clexane can affect the way some other
medicines work. Also some medicines can
affect the way Clexane works.
In particular, do not have this medicine
and tell your doctor if:
You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any of
the following medicines:
• Warfarin - used for thinning the blood
• Aspirin, dipyridamole, clopidogrel or
other medicines – used to stop blood
clots forming

Operations and anaesthetics
If you are going to have a spinal puncture
or an operation where an epidural or
spinal anaesthetic is used, tell your doctor
that you are using Clexane. Tell also your
doctor if you have any problem with
your spine or if you have ever had spinal
surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this
medicine if you are pregnant, might
become pregnant, or think you may be
pregnant.
You should not use this medicine if you are
pregnant and have a mechanical heart valve
as you may be at increased risk of developing
blood clots. Your doctor should discuss this
with you.

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
100mg/ml
Solution for
injection
CLEXANE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

60mg / 0.6ml

60 od

0.60

45
50

80mg / 0.8ml
80mg / 0.8ml

67.5 od
75 od

0.675
0.75

55
60
65

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

82.5 od
90 od
97.5 od

0.825
0.90
0.975

NAME OF THE MEDICINAL PRODUCT

Clexane® 60 mg/0.6 ml Syringes

2

You have ever had a stroke

3. How to use Clexane
Having this medicine
• Before you use Clexane your doctor or
nurse may carry out a blood test

• When you go home you may need to
continue to use Clexane and give it to
yourself (see below instructions on how to
do this)
• Clexane is usually given by injection
underneath the skin (subcutaneous)
If you are not sure why you are receiving
Clexane or have any questions about how
much Clexane is being given to you, speak to
your doctor, pharmacist or nurse.
How much will be given to you
• Your doctor will decide how much to give
you. The amount of Clexane given to you
will depend on the reason it is being used

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
150mg/ml
Solution for
Injection
CLEXANE
FORTE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

70
75
80

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

105 od
112.5 od
120 od

0.70
0.76
0.80

85
90
95
100

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

127.5 od
135 od
142.5 od
150 od

Patient
weight

Injection
volume (ml)

Syringe label

Dose (mg)

40

40mg / 0.4ml

40 bd

45
50
55
60

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

45 bd
50 bd
55 bd
60 bd

0.40
0.45
0.50
0.55
0.60

65
70
75
80

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

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

100mg/ml
Solution for
Injection
CLEXANE
syringes

Kg

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

150mg/ml
Solution for
Injection
CLEXANE
FORTE
syringes

2) Stopping blood clots forming in your
blood in the following situations:

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

a) Unstable angina
• The usual amount is 1mg for every
kilogram of weight, every 12 hours
• Clexane will usually be given for 2 to
8 days. Your doctor will normally ask you
to take aspirin as well
b) After an operation or long periods of
bedrest due to illness
The usual dose is 20mg or 40mg each
day. The dose will depend on how likely
you are to develop a clot
• If you have a low to medium risk of
getting a clot, you will be given 20mg
of Clexane each day. If you are going to
have an operation, your first injection
will usually be given 2 hours before your
operation
• If you have a higher risk of getting a clot,
you will be given 40mg each day. If you
are going to have an operation, your first
injection will usually be given 12 hours
before your operation
• If you are bedridden due to illness,
you will be normally be given 40mg of
Clexane each day for 6 to 14 days

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

105
110
115
120

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

105 bd
110 bd
115 bd
120 bd

0.70
0.74
0.78
0.80

125
130
135
140
145
150

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

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

0.84
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.

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
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 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) Stop blood clots forming in the
tubes of your dialysis machine
• The usual dose is 1 mg for every kilogram
of your weight
• Clexane is added to the tube leaving
the body (arterial line) at the start of the
dialysis session
• This amount is usually enough for a
4 hour session. However, your doctor
may give you a further dose of 0.5 to
1mg for every kilogram of your weight if
necessary
How to give yourself an injection of
Clexane
If you are able to give Clexane to yourself,
your doctor or nurse will show you how to do
this. Do not try to inject yourself if you have
not been trained how to do so. If you are not
sure what to do, talk to your doctor or nurse
immediately.

Turn
Over

Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours
(max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2
Posology and method of administration: Elderly.

0.86
0.90
0.96
1.00

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

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.

• If you have problems with your kidneys,
you may be given a smaller amount of
Clexane

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.

PHARMACEUTICAL FORM

Solution for injection.
Clear 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.

Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.

1) Treating blood clots that are in your
blood
• The usual dose is 1.5mg for every
kilogram of your weight, each day
• Clexane will usually be given for at least 5
days

Dosage chart for 1mg/kg SC treatment of STEMI
Syringe label

Dose (mg)

40mg / 0.4ml

40 bd

45
50
55
60

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

45 bd
50 bd
55 bd
60 bd

0.45
0.50
0.55
0.60

65
70
75
80

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

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

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 STEMI

0.40

85
90
95
100

100mg/ml
Solution for
Injection
CLEXANE
syringes

Kg

Injection
volume (ml)

40

Patient
weight

Patient
weight

150mg/ml
Solution for
Injection
CLEXANE
FORTE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

105
110
115
120

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

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

0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1)

125
130
135
140
145
150

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

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

0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1)

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodium should be given between 15 minutes
before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as
having STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours
before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV
bolus of 0.3mg/kg of enoxaparin sodium should be administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If
fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 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,
and Monitoring; section 5.2 Pharmacokinetic properties).
Turn
Over

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

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.

Before injecting yourself with Clexane
Check the expiry date on the medicine. Do
not use if the date has passed
Check the syringe is not damaged and the
medicine in it is a clear solution. If not,
use another syringe
Make sure you know how much you are
going to inject
Check your abdomen to see if the last
injection caused any redness, change
in skin colour, swelling, oozing or is still
painful, if so talk to your doctor or nurse
Decide where you are going to inject the
medicine. Change the place where you
inject each time from the right to the
left side of your stomach. Clexane should
be injected just under the skin on your
stomach, but not too near the belly button
or any scar tissue (at least 5 cm away from
these)

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 - needle first - into
the sharps bin provided. Close the
container lid tightly and place the container
out of reach of children.

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.

Make sure you hold the skin fold throughout
the injection.

Remember: Do not inject yourself within 5
centimetres of your belly button or around
existing scars or bruises. Change the place
where you inject between the left and right
sides of your stomach, depending on the
area you were last injected.

Instructions on injecting yourself with
Clexane:

6) Hold the syringe so that the needle is
pointing downwards (vertically at a 90º
angle). Insert the full length of the needle into
the skin fold
7) Press down on the plunger with your finger.
This will send the medication into the fatty
tissue of the stomach. Make sure you hold
the skin fold throughout the injection

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

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

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 more Clexane than you
should
If you think that you have used too much or
too little Clexane, tell your doctor, nurse or
pharmacist immediately, even if you have
no signs of a problem. If a child accidentally
injects or swallows Clexane, take them to a
hospital casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as
soon as you remember. Do not give yourself
a double dose on the same day to make up
for a forgotten dose. Keeping a diary will help
to make sure you do not miss a dose

Dosage chart for 0.75mg/kg SC treatment of STEMI

100mg/ml
Solution for Injection
CLEXANE syringes

150mg/ml
Solution for Injection
CLEXANE FORTE syringes

Syringe label

40
45
50
55
60
65
70
75
80
85
90
95
100
105

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

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)

110
115
120
125
130
135
140
145
150

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

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)

0.75mg/kg Dose (mg)

Adjusted dosing (mg)
30 bd
35 bd
37.5 bd
42.5 bd
45 bd
50 bd
52.5 bd
57.5 bd
60 bd
65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)

Injection volume (ml)
0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60
0.65
0.675
0.725
0.75
0.80 (1)

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)

0.825 (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:
Dosage adjustments for therapeutic dosage range
Standard dosing

Severe renal impairment

1 mg/kg SC twice daily

1 mg/kg SC once daily
1 mg/kg SC once daily

1.5 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)

4. Possible side-effects
Like all medicines, Clexane can cause sideeffects, 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.

Rare (affects less than 1 in a 1000 people)
• If you have an allergic reaction. The
signs may include: a rash, swallowing
or breathing problems, swelling of your
lips, face, throat or tongue.
• If you have had a spinal puncture or a
spinal anaesthetic and notice tingling,
numbness and muscular weakness,
particularly in the lower part of your
body. Also if you lose control over your
bladder or bowel (so you cannot control
when you go to the toilet).
Tell a nurse or doctor as soon as possible
if you notice any of the following side
effects:
Common (affects 1 to 10 people in a 100)
• You bruise more easily than usual. This
could be because of a blood problem
(thrombocytopenia).
• You have pain, swelling or irritation in
the area you have been injected with
Clexane. This normally gets better after a
few days.
Rare (affects less than 1 in a 1000 people)
• If you have a mechanical heart valve,
treatment with Clexane might not be
sufficient to prevent blood clots. You may
notice that you have difficulty breathing,
tiredness or difficulty exercising, chest
pain, numbness, feeling sick or loss of
consciousness. This could be due to a
blood clot on the heart valve

Dosage adjustments for prophylactic dosage ranges

(elderly patients aged ≥75 years only)

Kg

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

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.

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).

Patient weight

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

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.
1mg/kg SC once daily without initial bolus.
(Max 75mg for each of the first two SC doses)
(Max 100mg for first SC dose only)

Standard dosing
40 mg SC once daily
20 mg SC once daily

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

The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal
impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring is advised.
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.
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be administered when the patient is lying down by deep subcutaneous
injection. The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall. The whole length of
the needle should be introduced vertically into a skin fold held between the thumb and index finger. The skin fold should not be released until the
injection is complete.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be used. Enoxaparin sodium should be
administered through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of
enoxaparin sodium with all other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution
prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely
administered with normal saline solution (0.9%) or 5% dextrose in water.
• Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or 100mg), expel the excessive volume to retain only 30mg
(0.3ml) in the syringe. The 30mg dose can then be directly injected into an injection site in the intravenous line.
• Additional bolus for PCI when last SC administration was given more than 8 hours before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3mg/kg is to be administered if last SC
administration was given more than 8 hours before balloon inflation (see section 4.2 Posology and method of administration: Treatment of acute
ST-segment Elevation Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to use a 50ml infusion bag (i.e. using either
normal saline solution (0.9%) or 5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60mg enoxaparin sodium prefilled
syringe into the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for
administration into the intravenous line (using an appropriate injection site or port).

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.

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.

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.

If the product becomes discoloured or shows
any other signs of deterioration, you should
consult your pharmacist who will advise you
what to do.

Frequency unknown
• If Clexane is used for a long period of
time, it may increase the risk of you
getting a condition called ‘osteoporosis’.
This is when your bones are more likely
to break
5. How to store and dispose of Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date
which is stated on the carton. The expiry date
refers to the last day of that month.

6. Further Information
What Clexane contains
• Each pre-filled syringe contains 60 mg
enoxaparin sodium (equivalent to 6,000 IU
anti-Xa activity) in 0.6 ml water for injection.
What Clexane Pre-filled Syringes look like
and contents of the pack
Clexane is a clear solution in a Type 1 glass
pre-filled syringe fitted with an orange plastic
plunger and fitted with an injection needle and
needle cap. Clexane is supplied in packs of 2
or 10 syringes.

Product
Licence
Manufacturer

Holder

and

Procured from within the EU. Product Licence
Holder Ginova Ltd, repackager Ginova UK Ltd,
both of St James’ House, 8 Overcliffe,
Gravesend, Kent, DA11 0HJ.
Manufacturers:
Sanofi Winthrop Industrie, 180 Rue Jean
Jaurès, 94702 Maisons Alfort, France.
Sanofi
Winthrop
Industrie,
Boulevard
Industriel, 76580 Le Trait, France.
Sanofi-Aventis SA, Avenida de Leganes, 62,
28925 Alcorcon, Madrid, Spain.
Chinoin Pharmaceutical and Chemical Works
Private Co. Ltd, Csanyikvolgy Site, Miskolc,
Csanyikvolgy, H-3510, Hungary.
Clexane 60 mg/0.6 ml Syringes
PL No: 18067/0398

POM

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 on
2nd July 2013.
Clexane® is a registered trademark of Aventis
Pharma SA, France.

Do not store above 25°C. Do not refrigerate or
freeze.

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

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

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

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

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

Required dose
(0.3mg/kg)
(mg)
30
31.5
33
34.5
36
37.5
39
40.5
42
43.5
45

Volume to inject when diluted to a
final concentration of 3mg/ml
(ml)
10
10.5
11
11.5
12
12.5
13
13.5
14
14.5
15

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
36 months
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers - discard any unused product
6.5 Nature and contents of container
Clear solution in a Type 1 glass pre-filled syringe fitted with an orange plastic plunger fitted with an injection needle and a needle cap.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
10

DATE OF REVISION OF THE TEXT
02/07/2013
503996/PL1b

503998/PL1b

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Enoxaparin Sodium 60 mg/0.6 ml
Syringes
This product is available in other strengths.

Is this leaflet hard to see or read?
Phone 01622 693000 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 or pharmacist
• This medicine has been prescribed for you.
Do not pass it onto others. It may harm
them, even if their symptoms are the same
as yours
• If any of the side effects get serious, or
if you notice any side effects not listed
in this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What Enoxaparin Sodium is and what it is
used for
2. Before you use Enoxaparin Sodium
3. How to use Enoxaparin Sodium
4. Possible side-effects
5. How to store Enoxaparin Sodium
6. Further information

1. What Enoxaparin Sodium is
and what it is used for
The name of your medicine is Enoxaparin
Sodium 60 mg/0.6 ml Syringes, (called
Enoxaparin Sodium in this leaflet). Enoxaparin
Sodium contains a medicine called enoxaparin
sodium. This belongs to a group of medicines
called Low Molecular Weight Heparins.
Enoxaparin Sodium 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.
Enoxaparin Sodium 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)

You are allergic (hypersensitive)
to enoxaparin sodium or any of
the other ingredients of Enoxaparin Sodium
(listed in Section 6: Further information)
Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
You are allergic to heparin or other
Low Molecular Weight Heparins such as
tinzaparin or dalteparin
You have a problem with bruising or
bleeding too easily
You have an ulcer in your stomach or gut
(intestine)
You have had a stroke caused by bleeding
in the brain
You have an infection in your heart
You are using the medicine called heparin
to treat blood clots
Do not have this medicine if any of the
above apply to you. If you are not sure,
talk to your doctor, pharmacist or nurse
before having Enoxaparin Sodium.
Take special care with Enoxaparin
Sodium
Check with your doctor or pharmacist or
nurse before using this medicine if:
You have high blood pressure
You have kidney problems
You have had a heart valve fitted

2. Before you use Enoxaparin Sodium
Do not have this medicine and tell
your doctor, pharmacist or nurse if:

You have ever had bruising and bleeding
caused by the medicine ‘heparin’
You have ever had a stroke

Enoxaparin Sodium 60mg/0.6 ml Syringes
The following information is extracted from the SPC
Technical information for the administration of Enoxaparin Sodium Syringes

You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and
especially if you are aged over 75 years old
If you are not sure if any of the above
applies to you, talk to your doctor or
pharmacist or nurse before using Enoxaparin
Sodium.
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
Enoxaparin Sodium can affect the way some
other medicines work. Also some medicines
can affect the way Enoxaparin Sodium works.
In particular, do not have this medicine
and tell your doctor if:
You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any of
the following medicines:
• Warfarin - used for thinning the blood
• Aspirin, dipyridamole, clopidogrel or
other medicines – used to stop blood
clots forming
• Dextran injection - used as a blood
replacer

Your doctor may change one of your
medicines or take regular blood tests to check
that taking these medicines with Enoxaparin
Sodium 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 Enoxaparin Sodium. Tell
also your doctor if you have any problem with
your spine or if you have ever had spinal
surgery.

3. How to use Enoxaparin Sodium
Having this medicine
• Before you use Enoxaparin Sodium your
doctor or nurse may carry out a blood test
• While you are in hospital your doctor or
nurse will normally give you Enoxaparin
Sodium. This is because it needs to be
given as an injection
• When you go home you may need to
continue to use Enoxaparin Sodium and
give it to yourself (see below instructions
on how to do this)
• Enoxaprin Sodium is usually given by
injection underneath the skin (subcutaneous)
If you are not sure why you are receiving
Enoxaparin Sodium or have any questions
about how much Enoxaparin Sodium is being
given to you, speak to your doctor, pharmacist
or nurse.

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.

How much will be given to you
• Your doctor will decide how much to give
you. The amount of Enoxaprin Sodium
given to you will depend on the reason it is
being used

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

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

60mg / 0.6ml

60 od

0.60

45
50

80mg / 0.8ml
80mg / 0.8ml

67.5 od
75 od

0.675
0.75

55
60
65

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

82.5 od
90 od
97.5 od

0.825
0.90
0.975

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient
weight
150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
FORTE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

70
75
80

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

105 od
112.5 od
120 od

0.70
0.76
0.80

85
90
95
100

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

127.5 od
135 od
142.5 od
150 od

0.86
0.90
0.96
1.00

Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Enoxaparin Sodium every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325mg once
daily). Treatment with Enoxaparin Sodium 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.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Pre-filled syringes:
Enoxaparin Sodium 60 mg (equivalent to 6,000 IU anti-Xa activity)

Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.

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.

This product is available in other strengths.

60 mg Injection

You should not breast-feed whilst using
Enoxaparin Sodium. If you are planning to
breast-feed, talk to your doctor, pharmacist or
nurse.

Pregnancy and breast-feeding
Talk to your doctor before you use this
medicine if you are pregnant, might
become pregnant, or think you may be
pregnant.

NAME OF THE MEDICINAL PRODUCT

Enoxaparin Sodium 60 mg/0.6 ml Syringes

in 0.6 mL Water for Injections

For full list of excipients, see section 6.1

3

You are a diabetic or have an illness known
as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by diabetes)

100mg/ml
Solution for
injection
ENOXAPARIN
SODIUM
syringes

enoxaparin sodium

2

• Ibuprofen, diclofenac, ketorolac or
other medicines - used to treat pain
and swelling in arthritis and other
illnesses
• Prednisolone,
dexamethasone
or
other medicines - used to treat
asthma,
rheumatoid
arthritis
and
other conditions
• Water tablets (diuretics) such as
spironolactone, triamterene or amiloride.
These may increase the levels of potassium
in your blood when taken with Enoxaparin
Sodium

You have ever had a stomach ulcer

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

1

You have recently had an operation on
your eyes or brain

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

Solution for injection.
Clear 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:
Enoxaparin Sodium should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Enoxaparin Sodium treatment is usually
prescribed for at least 5 days and until adequate oral anticoagulation is established.

Injection
volume (ml)

Dose (mg)

40mg / 0.4ml

40 bd

45
50
55
60

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

45 bd
50 bd
55 bd
60 bd

0.40
0.45
0.50
0.55
0.60

65
70
75
80

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

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

85
90
95
100

100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes

Syringe label

40

PHARMACEUTICAL FORM

Kg

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

150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
FORTE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

105
110
115
120

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

105 bd
110 bd
115 bd
120 bd

0.70
0.74
0.78
0.80

125
130
135
140
145
150

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

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

0.84
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.

c) After you have had a heart attack
Enoxaparin Sodium can be used for two
different types of heart attack called
NSTEMI or STEMI. The amount of
Enoxaparin Sodium given to you will
depend on your age and the kind of heart
attack you have had.

• If you have problems with your kidneys,
you may be given a smaller amount of
Enoxaparin Sodium
1) Treating blood clots that are in your
blood
• The usual dose is 1.5mg for every
kilogram of your weight, each day
• Enoxaparin Sodium will usually be given
for at least 5 days

i) NSTEMI type of heart attack
• The usual amount is 1mg for every
kilogram of weight, every 12 hours
• Enoxaparin Sodium will usually be
given for 2 to 8 days. Your doctor will
normally ask you to take aspirin as well

2) Stopping blood clots forming in your
blood in the following situations:
a) Unstable angina
• The usual amount is 1mg for every
kilogram of weight, every 12 hours
• Enoxaparin Sodium will usually be given
for 2 to 8 days. Your doctor will normally
ask you to take aspirin as well
b) After an operation or long periods of
bedrest due to illness
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 Enoxaparin Sodium each day. If you
are going to have an operation, your
first injection will usually be given 2
hours before your operation
• If you have a higher risk of getting a clot,
you will be given 40mg each day. If you
are going to have an operation, your first
injection will usually be given 12 hours
before your operation
• If you are bedridden due to illness,
you will be normally be given 40mg of
Enoxaparin Sodium each day for 6 to 14
days

ii) STEMI type of heart attack
If you are under 75 years old
• 30mg of Enoxaparin Sodium will be
given as an injection into your vein
intravenous injection using Enoxaparin
Sodium Multidose Vial or 60, 80 or 100mg
Pre-filled syringes)
• At the same time, you will also be given
Enoxaparin Sodium as an injection under
your skin (subcutaneous injection). The
usual dose is 1mg for every kilogram of
your weight.
• Then you will be given 1mg for every
kilogram of your weight every 12 hours
after that
• The maximum amount of Enoxaparin
Sodium 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 Enoxaparin Sodium under
your skin (subcutaneous injection)
• The usual dose is 0.75mg for every
kilogram of your weight, every 12 hours
• The maximum amount of Enoxaparin
Sodium 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
Enoxaparin Sodium, your doctor may
decide to give an additional dose of
Enoxaparin Sodium before a PCI
operation. This is by injection into your
vein
(intravenous
using
Enoxaparin
Sodium 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 1 mg for every kilogram
of your weight
• Enoxaparin Sodium 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

Turn
Over

Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours
(max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2
Posology and method of administration: Elderly.
Dosage chart for 1mg/kg SC treatment of STEMI
Syringe label

Dose (mg)

40mg / 0.4ml

40 bd

45
50
55
60

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

45 bd
50 bd
55 bd
60 bd

0.45
0.50
0.55
0.60

65
70
75
80

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

65 bd
70 bd
75 bd
80 bd

0.65
0.70
0.75
0.80

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 STEMI

0.40

85
90
95
100

100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes

Kg

Injection
volume (ml)

40

Patient
weight

Patient
weight

150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
FORTE
syringes

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

105
110
115
120

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

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

0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1)

125
130
135
140
145
150

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

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

0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1)

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodium should be given between 15 minutes
before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as
having STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours
before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV
bolus of 0.3mg/kg of enoxaparin sodium should be administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If
fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 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,
and Monitoring; section 5.2 Pharmacokinetic properties).
Turn
Over

How to give yourself an injection of
Enoxaparin Sodium
If you are able to give Enoxaparin Sodium 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.

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).

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.

Dosage chart for 0.75mg/kg SC treatment of STEMI

7) Press down on the plunger with your finger.
This will send the medication into the fatty
tissue of the stomach. Make sure you hold
the skin fold throughout the injection

Syringe label

40
45
50
55
60
65
70
75
80
85
90
95
100
105

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

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)

110
115
120
125
130
135
140
145
150

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

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)

0.75mg/kg Dose (mg)

Adjusted dosing (mg)
30 bd
35 bd
37.5 bd
42.5 bd
45 bd
50 bd
52.5 bd
57.5 bd
60 bd
65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)

Injection volume (ml)
0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60
0.65
0.675
0.725
0.75
0.80 (1)

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)
0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1)

Dosage adjustments for therapeutic dosage range
Standard dosing

Severe renal impairment

1 mg/kg SC twice daily

1 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)

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

Blood Tests
Using Enoxaparin Sodium 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 Enoxaparin Sodium.
4. Possible side-effects
Like all medicines, Enoxaparin Sodium 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 Enoxaparin Sodium.

Rare (affects less than 1 in a 1000 people)
• If you have an allergic reaction. The
signs may include: a rash, swallowing
or breathing problems, swelling of your
lips, face, throat or tongue.
• If you have had a spinal puncture or a
spinal anaesthetic and notice tingling,
numbness and muscular weakness,
particularly in the lower part of your
body. Also if you lose control over your
bladder or bowel (so you cannot control
when you go to the toilet).
Tell a nurse or doctor as soon as possible
if you notice any of the following side
effects:
Common (affects 1 to 10 people in a 100)
• You bruise more easily than usual. This
could be because of a blood problem
(thrombocytopenia).
• You have pain, swelling or irritation in the
area you have been injected with
Enoxaparin Sodium. 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 Enoxaparin Sodium 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

Dosage adjustments for prophylactic dosage ranges

150mg/ml
102 bd (1)
Solution for Injection
105 bd (1)
ENOXAPARIN SODIUM
111 bd (1)
114 bd (1)
FORTE syringes
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
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:

1.5 mg/kg SC once daily

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

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

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.

(elderly patients aged ≥75 years only)

Kg

100mg/ml
Solution for Injection
ENOXAPARIN SODIUM
syringes

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
Enoxaparin Sodium syringe. Throw away
the cap. The syringe is pre-filled and ready
to use.

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

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

Make sure you hold the skin fold throughout
the injection.

Remember: Do not inject yourself within 5
centimetres of your belly button or around
existing scars or bruises. Change the place
where you inject between the left and right
sides of your stomach, depending on the
area you were last injected.

Instructions on injecting yourself with
Enoxaparin Sodium:

Patient weight

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

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.

Before injecting yourself with Enoxaparin
Sodium
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. Enoxaparin Sodium 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)

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

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.
1mg/kg SC once daily without initial bolus.
(Max 75mg for each of the first two SC doses)
(Max 100mg for first SC dose only)

Standard dosing
40 mg SC once daily
20 mg SC once daily

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

The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal
impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring is advised.
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).
Enoxaparin Sodium 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.
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Enoxaparin Sodium should be administered when the patient is lying down by deep subcutaneous
injection. The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall. The whole length of
the needle should be introduced vertically into a skin fold held between the thumb and index finger. The skin fold should not be released until the
injection is complete.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be used. Enoxaparin sodium should be
administered through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of
enoxaparin sodium with all other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution
prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely
administered with normal saline solution (0.9%) or 5% dextrose in water.
• Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or 100mg), expel the excessive volume to retain only 30mg
(0.3ml) in the syringe. The 30mg dose can then be directly injected into an injection site in the intravenous line.
• Additional bolus for PCI when last SC administration was given more than 8 hours before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3mg/kg is to be administered if last SC
administration was given more than 8 hours before balloon inflation (see section 4.2 Posology and method of administration: Treatment of acute
ST-segment Elevation Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to use a 50ml infusion bag (i.e. using either
normal saline solution (0.9%) or 5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60mg enoxaparin sodium prefilled
syringe into the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for
administration into the intravenous line (using an appropriate injection site or port).

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 Enoxaparin Sodium.

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.

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.

If the product becomes discoloured or shows
any other signs of deterioration, you should
consult your pharmacist who will advise you
what to do.

Frequency unknown
• If Enoxaparin Sodium is used for a long
period of time, it may increase the risk of
you getting a condition called ‘osteoporosis’.
This is when your bones are more likely
to break
5. How to store and dispose of
Enoxaparin Sodium
Keep out of the sight and reach of children.
Do not use Enoxaparin Sodium after the expiry
date which is stated on the carton. The expiry
date refers to the last day of that month.

6. Further Information
What Enoxaparin Sodium contains
• Each pre-filled syringe contains 60 mg
enoxaparin sodium (equivalent to 6,000 IU
anti-Xa activity) in 0.6 ml water for injection.
What
Enoxaparin
Sodium
Pre-filled
Syringes look like and contents of the pack
Enoxaparin Sodium is a clear solution in a Type
1 glass pre-filled syringe fitted with an orange
plastic plunger and fitted with an injection
needle and a needle cap. Enoxaparin Sodium
is supplied in packs of 2 or 10 syringes.

Product
Licence
Manufacturer

Holder

and

Procured from within the EU. Product Licence
Holder Ginova Ltd repackager Ginova UK Ltd,
both of St James’ House, 8 Overcliffe,
Gravesend, Kent, DA11 0HJ.
Manufacturers:
Sanofi Winthrop Industrie, 180 Rue Jean
Jaurès, 94702 Maisons Alfort, France.
Sanofi
Winthrop
Industrie,
Boulevard
Industriel, 76580 Le Trait, France.
Sanofi-Aventis SA, Avenida de Leganes, 62,
28925 Alcorcon, Madrid, Spain.
Chinoin Pharmaceutical and Chemical Works
Private Co. Ltd, Csanyikvolgy Site, Miskolc,
Csanyikvolgy, H-3510, Hungary.
Enoxaparin Sodium 60 mg/0.6 ml Syringes
PL No: 18067/0398
POM
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 on
2nd July 2013.

Do not store above 25°C. Do not refrigerate or
freeze.

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

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

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

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

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

Required dose
(0.3mg/kg)
(mg)
30
31.5
33
34.5
36
37.5
39
40.5
42
43.5
45

Volume to inject when diluted to a
final concentration of 3mg/ml
(ml)
10
10.5
11
11.5
12
12.5
13
13.5
14
14.5
15

6
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Subcutaneous Injection
Enoxaparin Sodium should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose in water.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Enoxaparin Sodium pre-filled syringes are single dose containers - discard any unused product
6.5 Nature and contents of container
clear solution in a Type 1 glass pre-filled syringe fitted with an orange plastic plunger fitted with an injection needle and a needle cap.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
10

DATE OF REVISION OF THE TEXT
02/07/2013
503998/PL1b

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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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