Skip to Content

ENOXAPARIN SODIUM 40MG/0.4ML SYRINGES

Active substance(s): ENOXAPARIN SODIUM / ENOXAPARIN SODIUM

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE USER



Clexane® 40mg/0.4ml Syringes

 After you have had a heart attack
Stop blood clots forming in the tubes of your
dialysis machine (used for people with kidney
problems)

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

(enoxaparin sodium)

2. Before you use Clexane

Read all of this leaflet carefully before you start
using this medicine
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your doctor
or pharmacist
 This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours
 If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist
The name of your medicine is Clexane 40mg/0.4ml
Syringes but it will be referred as Clexane throughout
this leaflet. Please note that the leaflet also contains
information about other strengths, Clexane 20mg,
60mg, 80mg and 100mg Syringes.
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

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

1. What Clexane is and what it is
used for

Take special care with Clexane
Check with your doctor or pharmacist or nurse
before using this medicine if:
 You have high blood pressure
 You have kidney problems
 You have had a heart valve fitted
 You have ever had bruising and bleeding caused
by the medicine ‘heparin’
 You have ever had a stroke
 You have ever had a stomach ulcer
 You have recently had an operation on your eyes
or brain
You are 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

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


1
7
1
5
6
6
0
4

Please tell your doctor, pharmacist or nurse if you
are taking or have recently taken any other
medicines. This includes medicines you buy without
a prescription, including herbal medicines. This is
because Clexane can affect the way some other
medicines work. Also some medicines can affect the
way Clexane works.
In particular, do not have this medicine and
tell your doctor if:
 You are using the medicine called heparin to
treat blood clots
Tell your doctor if you are taking any of the
following medicines:
 Warfarin - used for thinning the blood
 Aspirin, dipyridamole, clopidogrel or other
medicines – used to stop blood clots forming
 Dextran injection - used as a blood replacer
 Ibuprofen, diclofenac, ketorolac or other
medicines – used to treat pain and swelling in
arthritis and other illnesses
 Prednisolone, dexamethasone or other medicines
– used to treat asthma, rheumatoid arthritis and
other conditions
 Water tablets (diuretics) such as spironolactone,
triamterene or amiloride. These may increase the
levels of potassium in your blood when taken with
Clexane
Your doctor may change one of your medicines or
take regular blood tests to check that taking these
medicines with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an
operation where an epidural or spinal anaesthetic is
used, tell your doctor that you are using Clexane.
Tell also your doctor if you have any 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.

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

Clexane® 40mg/0.4ml Syringes
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes

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

1 NAME OF THE MEDICINAL PRODUCT
®
Clexane Syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
40mg Injection Enoxaparin sodium 40mg (equivalent to 4000 IU anti-Xa activity) in 0.4mL 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
20mg (2,000IU) 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 40mg (4,000IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for
cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40mg (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 1.5mg/kg (150 IU/kg).
Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is
established.

Syringe label
Kg

weight

Dose (mg)

Injection
volume (ml)

150mg/ml

70

120mg / 0.8ml

105 od

0.70

75

120mg / 0.8ml

112.5 od

0.76

Injection

80

120mg / 0.8ml

120 od

0.80

CLEXANE

85

150mg / 1ml

127.5 od

0.86

Forte

90

150mg / 1ml

135 od

0.90

syringes

95

150mg / 1ml

142.5 od

0.96

100

150mg/ 1ml

150 od

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 1mg/kg Clexane every 12 hours by subcutaneous injection, administered
concurrently with oral aspirin (100 to 325mg once daily).
Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and continued
until clinical stabilisation. The usual duration of treatment is 2 to 8 days.

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

Kg

Syringe label

Dose (mg)

weight

Injection
Dose (mg)

Syringe label

Solution for

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

Kg

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

45

60mg / 0.6ml

45 bd

0.45

50

60mg / 0.6ml

50 bd

0.50

55

60mg / 0.6ml

55 bd

0.55

volume
(ml)

100mg/ml

60

60mg / 0.6ml

60 bd

0.60

100mg/ml

40

60mg / 0.6ml

60 od

0.60

Solution for

65

80mg / 0.8ml

65 bd

0.65

Solution for

45

80mg / 0.8ml

67.5 od

0.675

Injection

70

80mg / 0.8ml

70 bd

0.70

injection

50

80mg / 0.8ml

75 od

0.75

CLEXANE

75

80mg / 0.8ml

75 bd

0.75

CLEXANE

55

100mg / 1ml

82.5 od

0.825

syringes

80

80mg / 0.8ml

80 bd

0.80

syringes

60

100mg / 1ml

90 od

0.90

85

100mg / 1ml

85 bd

0.85

65

100mg / 1ml

97.5 od

0.975

90

100mg / 1ml

90 bd

0.90

95

100mg / 1ml

95 bd

0.95

100

100mg / 1ml

100 bd

1.00

b) After an operation or long periods of bedrest

You should not breast-feed whilst using Clexane. If
you are planning to breast-feed, talk to your doctor,
pharmacist or nurse.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or breastfeeding.

3. How to use Clexane
Having this medicine
 Before you use Clexane your doctor or nurse
may carry out a blood test
 While you are in hospital your doctor or nurse will
normally give you Clexane. This is because it
needs to be given as an injection
 When you go home you may need to continue to
use Clexane and give it to yourself (see below
instructions on how to do this)
 Clexane is usually given by injection underneath
the skin (subcutaneous)
 Do not inject Clexane into a muscle
(intramuscular)
If you are not sure why you are receiving Clexane or
have any questions about how much Clexane is
being given to you, speak to your doctor, pharmacist
or nurse.
How much will be given to you
 Your doctor will decide how much to give you.
The amount of Clexane given to you will depend
on the reason it is being used
 If you have problems with your kidneys, you may
be given a smaller amount of Clexane
1) Treating blood clots that are in your
blood
 The usual dose is 1.5mg for every kilogram of
your weight, each day
 Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in
the following situations:
a) Unstable angina
 The usual amount is 1mg for every kilogram of
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


1
7
1
5
6
6
0
4

due to illness
The usual dose is 20mg or 40mg each day. The
dose will depend on how likely you are to develop
a clot
 If you have a low to medium risk of getting a clot,
you will be given 20mg of Clexane each day for 7
to 10 days. If you are going to have an operation,
your first injection will usually be given 2 hours
before your operation
 If you have a higher risk of getting a clot, you will
be given 40mg each day for 7 to 28 days. If you
are going to have an operation, your first injection
will usually be given 12 hours before your
operation
 If you are bedridden due to illness, you will be
normally be given 40mg of Clexane each day for
6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of heart
attack called NSTEMI or STEMI.
The amount of Clexane given to you will depend on
your age and the kind of heart attack you have had.
i) NSTEMI type of heart attack
 The usual amount is 1mg for every kilogram of
weight, every 12 hours
 Clexane will usually be given for 2 to 8 days.
Your doctor will normally ask you to take aspirin
as well
ii) STEMI type of heart attack
If you are under 75 years old
 30mg of Clexane will be given as an injection into
your vein (intravenous injection using Clexane
Multidose Vial or 60, 80 or 100mg Pre-filled
syringes)
 At the same time, you will also be given Clexane
as an injection under your skin (subcutaneous
injection). The usual dose is 1mg for every
kilogram of your weight.
 Then you will be given 1mg for every kilogram of your
weight every 12 hours
 The maximum amount of Clexane given for the
first two injections 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 Prefilled syringes)
3) Stopping blood clots forming in the tubes of
your dialysis machine
 The usual dose is 1mg for every kilogram of your
weight
 Clexane 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.
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 5cm away
from these)



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

Kg

Syringe label

Dose (mg)

weight

Dosage chart for 1mg/kg SC treatment of STEMI

Injection

Patient

volume (ml)

Injection
Kg

Syringe label

Dose (mg)

weight

volume (ml)

105

120mg / 0.8ml

105 bd

0.70

110

120mg / 0.8ml

110 bd

0.74

105

120mg / 0.8ml (1)

105 bd (1)

0.70 (1)

150mg/ml

115

120mg / 0.8ml

115 bd

0.78

110

120mg / 0.8ml (1)

110 bd (1)

0.74 (1)

Solution for

120

120mg / 0.8ml

120 bd

0.80

150mg/ml

115

120mg / 0.8ml (1)

115 bd (1)

0.78 (1)

Injection

125

150mg / 1ml

125 bd

0.84

Solution for

120

120mg / 0.8ml (1)

120 bd (1)

0.80 (1)

CLEXANE
Forte

130

150mg / 1ml

130 bd

0.88

Injection

125

150mg / 1ml (1)

125 bd (1)

0.84 (1)

135

150mg / 1ml

135 bd

0.90

CLEXANE

130

150mg / 1ml (1)

130 bd (1)

0.88 (1)

syringes

140

150mg / 1ml

140 bd

0.94

135

150mg / 1ml (1)

135 bd (1)

0.90 (1)

145

150mg / 1ml

145 bd

0.98

Forte
syringes

150

150mg / 1ml

150 bd

1.00

140

150mg / 1ml (1)

140 bd (1)

0.94 (1)

145

150mg / 1ml (1)

145 bd (1)

0.98 (1)

150

150mg / 1ml (1)

150 bd (1)

1.00 (1)

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg 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
Patient

Injection
Kg

Syringe label

Dose (mg)

weight

volume (ml)

(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.

40

40mg / 0.4ml

40 bd

0.40

45

60mg / 0.6ml

45 bd

0.45

50

60mg / 0.6ml

50 bd

0.50

100mg/ml

55

60mg / 0.6ml

55 bd

0.55

Solution for

60

60mg / 0.6ml

60 bd

0.60

injection

65

80mg / 0.8ml

65 bd

0.65

CLEXANE

70

80mg / 0.8ml

70 bd

0.70

syringes

75

80mg / 0.8ml

75 bd

0.75

A dose equivalent to 1mg/kg (100IU/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 100IU/kg) may be given. For patients at a high
risk of haemorrhage the dose should be reduced to 0.5mg/kg (50IU/kg) for double vascular access or
0.75mg/kg (75 IU/kg) for single vascular access.

80

80mg / 0.8ml

80 bd

0.80

Elderly:

85

100mg / 1ml

85 bd

0.85

90

100mg / 1ml

90 bd

0.90

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).

95

100mg / 1ml

95 bd

0.95

100

100mg / 1ml

100 bd

1.00

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:

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’).

4)

Instructions on injecting yourself with Clexane:

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

If you forget to use Clexane
If you forget to give yourself a dose, have it as soon as
you remember. Do not give yourself a double dose on
the same day to make up for a forgotten dose. Keeping
a diary will help to make sure you do not miss a dose
If you stop using Clexane
It is important for you to keep having Clexane injections
until your doctor decides to stop them. If you stop, you
could get a blood clot which can be very dangerous.
Blood Tests
Using Clexane may affect the results of some blood
tests. If you are going to have a blood test, it is important
to tell your doctor you are having Clexane.

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

4. Possible side effects
2) Sit or lie in a comfortable
position so you are
relaxed. Make sure you
can see the place you
are going to inject.
A lounge chair,recliner,
or bed propped up
with pillows is ideal.
3) Choose an area on the right or left side of your
stomach. This should be at least 5
centimetres away from your belly button and out
towards your sides.
Remember: Do not inject yourself within 5
centimetres of your belly button or around
existing scars or bruises. Change the place
where you inject between the left and right sides
of your stomach, depending on the area you were
last injected.
4) Carefully pull off the needle cap from the Clexane
syringe. Throw away the cap. The syringe is prefilled 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).


1
7
1
5
6
6
0
4

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

8) Remove the needle by pulling it straight out. You can
now let go of the skin fold.
To avoid bruising, do not rub the injection site
after you have injected yourself.
9) Drop the used syringe into the sharps bin provided.
Close the container lid tightly and place the container
out of reach of children.
When the container is full, give it to your doctor
or home care nurse for disposal. Do not put it in
the household rubbish.
If you have too much or too little Clexane
If you think that you have used too much or too little
Clexane, tell your doctor, nurse or pharmacist
immediately, even if you have no signs of a problem. If a
child accidentally injects or swallows Clexane, take them
to a hospital casualty department straight away.

Like all medicines, Clexane can cause side effects,
although not everybody gets them.
Tell a nurse or doctor or go to hospital straight away
if you notice any of the following side effects:
Very common (affects more than 1 in 10 people)
 Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
 A painful rash of dark red spots under the skin which
do not go away when you put pressure on them. You
may also notice pink patches on your skin. These are
more likely to appear in the area you have been
injected with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)
 Sudden severe headache. This could be a sign of
bleeding in the brain.
 A feeling of tenderness and swelling in your
stomach. You may have bleeding inside your
stomach.
Rare (affects less than 1 in a 1000 people)
 If you have an allergic reaction. The signs may
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.


Frequency unknown
If you have had a spinal puncture or a spinal anaesthetic
and notice tingling, numbness and muscular weakness,
particularly in the lower part of your body. Also if you
lose control over your bladder or bowel (so you cannot
control when you go to the toilet).



Dosage adjustments for therapeutic dosage range
Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged ≥75 years only)
Patient
0.75mg/kg Dose
Adjusted
Injection
weight
Kg
Syringe label
(mg)
dosing (mg)
volume (ml)
40

100mg/ml
Solution for
Injection
CLEXANE
syringes

150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes

60mg / 0.6ml

30 bd

30 bd

0.30

Standard dosing

Severe renal impairment

1mg/kg SC twice daily

1mg/kg SC once daily

1.5mg/kg SC once daily

1mg/kg SC once daily

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

45

60mg / 0.6ml

33.75 bd

35 bd

0.35

50

60mg / 0.6ml

37.5 bd

37.5 bd

0.375

55

60mg / 0.6ml

41.25 bd

42.5 bd

0.425

60

60mg / 0.6ml

45 bd

45 bd

0.45

65

60mg / 0.6ml

48.75 bd

50 bd

0.5

70

60mg / 0.6ml

52.5 bd

52.5 bd

0.525

75

60mg / 0.6ml

56.25 bd

57.5 bd

0.575

80

60mg / 0.6ml

60 bd

60 bd

0.60

85

80mg / 0.8ml

63.75 bd

65 bd

0.65

90

80mg / 0.8ml

67.5 bd

67.5 bd

0.675

Standard dosing

95

80mg / 0.8ml

71.25 bd

72.5 bd

0.725

40mg SC once daily

20mg SC once daily

100

80mg / 0.8ml

75 bd

75 bd

0.75

20mg SC once daily

20mg SC once daily

105

80mg / 0.8ml

78.75 bd (1)

80 bd (1)

0.80 (1)

110

100mg / 1ml

82.5 bd (1)

82.5 bd (1)

0.825 (1)

115

100mg / 1ml

86.25 bd (1)

87.5 bd (1)

0.875 (1)

120

100mg / 1ml

90 bd (1)

90 bd (1)

0.90 (1)

125

100mg / 1ml

93.75 bd (1)

95 bd (1)

0.95 (1)

130

100mg / 1ml

97.5 bd (1)

97.5 bd (1)

0.975 (1)

135

120mg / 0.8ml

101.25 bd (1)

102 bd (1)

0.68 (1)

140

120mg / 0.8ml

105 bd (1)

105 bd (1)

0.7 (1)

145

120mg / 0.8ml

108.75 bd (1)

111 bd (1)

0.74 (1)

150

120mg / 0.8ml

112.5 bd (1)

114 bd (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 < 30ml/min), according to the following tables, since enoxaparin sodium exposure
is significantly increased in this patient population:

Dosage adjustments for prophylactic dosage ranges
Severe renal impairment

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 30-50ml/min) or mild renal impairment (creatinine clearance 50-80ml/min),
careful clinical monitoring is advised.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 ‘Special warnings and
precautions for use:’ Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4
‘Special warnings and precautions for use: Low body weight and Monitoring;’ section 5.2
‘Pharmacokinetic properties’).
Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic
disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave
myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial
line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation
during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for
the initial dose of acute STEMI indication and before PCI when needed. It must not be
administered by the intramuscular route.

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.
Frequency unknown
 Feeling tired, faint, dizzy, having pale skin. These
could be symptoms of anaemia.
 You notice yellowing of your skin or eyes and
your urine becomes darker in colour. This could
be a liver problem.
Other side effects that you should discuss with
your nurse or doctor if you are concerned about
them:
Very common (affects more than 1 in 10 people)
 Changes in the results of blood tests done to
check how your liver is working. These usually go
back to normal after you stop having Clexane.
Rare (affects less than 1 in 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.
Frequency unknown
 If Clexane is used for a long period of time (more
than 3 months), it may increase the risk of you
getting a condition called ‘osteoporosis’. This is
when your bones are more likely to break
 Headache
 Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

5. How to store clexane







Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
Do not use Clexane after the expiry date which is
stated on the carton and blister label after ‘Exp’.
The expiry date refers to the last day of that
month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.


6. Further Information
What Clexane contains
The active ingredient in Clexane is enoxaparin
sodium.
Each pre-filled syringe contains 40mg of enoxaparin
sodium (equivalent to 4,000 IU anti-Xa activity), in
0.4ml water for injection.
The other ingredient is water for injection.
What Clexane looks like and contents of the pack
Clexane is a clear, colourless to pale yellow solution
for injection. It comes in glass pre-filled syringes
fitted with an injection needle and needle cap,
contained within individual sealed blister, blisters
contained within printed carton(s).
It is supplied in pack of 10 syringes.
Manufactured by: Chinoin Pharmaceutical and
Chemical Works Private Co. Ltd., Csanyikvolgy Site
Miszkolc, Csanyikvolgy, 3510, Hungary.




Procured from within the EU and repackaged by
the Product License holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Clexane® 40mg/0.4ml Syringes;
PL 18799/2989
Leaflet date: 18.04.2017

POM

Clexane is the registered trademark of Aventis
Pharma SA.

.


1
7
1
5
6
6
0
4

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.

Required dose

Volume to inject
when diluted to a
final

(0.3mg/kg)

concentration of
3mg/ml

(Kg)

(mg)

(ml)

4.5

100

30

10

15

5

105

31.5

10.5

55

16.5

5.5

110

33

11

60

18

6

115

34.5

11.5

65

19.5

6.5

120

36

12

70

21

7

125

37.5

12.5

75

22.5

7.5

130

39

13

80

24

8

135

40.5

13.5

85

25.5

8.5

140

42

14

90

27

9

145

43.5

14.5

95

28.5

9.5

150

45

15

Required
dose

Volume to inject
when diluted to a

(0.3mg/kg)

final
concentration of
3mg/ml

(Kg)

(mg)

(ml)

45

13.5

50

Weight

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.

Weight



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 STsegment 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 pre-filled syringe into the 20ml remaining in the bag.
Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe
for administration into the intravenous line (using an appropriate injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following formula
[Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is
recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use.
Volume to be injected through intravenous line after dilution is completed

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
Solution for injection in Type I glass pre-filled syringes fitted with injection needle in packs of 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 DATE OF REVISION OF THE TEXT
18.04.2017

PACKAGE LEAFLET:
INFORMATION FOR THE USER



Enoxaparin sodium 40mg/0.4ml
Syringes

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

2. Before you use Enoxaparin sodium

Read all of this leaflet carefully before you start
using this medicine
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your doctor
or pharmacist
 This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours
 If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist
The name of your medicine is Enoxaparin sodium
40mg/0.4ml Syringes but it will be referred as
Enoxaparin sodium throughout this leaflet. Please
note that the leaflet also contains information about
other strengths, Enoxaparin sodium 20mg, 60mg,
80mg and 100mg Syringes.
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

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
 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
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.
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.

Do not have this medicine and tell
your doctor, pharmacist or nurse if:
 You are allergic (hypersensitive) to enoxaparin
sodium or any of the other ingredients of
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 .

1. What Enoxaparin sodium is and
what it is used for

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
 You have ever had bruising and bleeding caused
by the medicine ‘heparin’
 You have ever had a stroke
 You have ever had a stomach ulcer
 You have recently had an operation on your eyes
or brain
You are a diabetic or have an illness known as
‘diabetic retinopathy’ (problems with the blood
vessels in the eye caused by diabetes)
 You have any problems with your blood
 You are underweight or overweight
 You are elderly (over 65 years old) and especially
if you are aged over 75 years old

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


1
7
1
5
6
6
0
4

 After you have had a heart attack
Stop blood clots forming in the tubes of your
dialysis machine (used for people with kidney
problems)

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

Enoxaparin sodium ® 40mg/0.4ml Syringes
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Enoxaparin sodium Syringes

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

1 NAME OF THE MEDICINAL PRODUCT
®
Enoxaparin sodium Syringes

Kg

Syringe label

Dose (mg)

Injection
volume
(ml)

150mg/ml

70

120mg / 0.8ml

105 od

0.70

Solution for

75

120mg / 0.8ml

112.5 od

0.76

Injection

80

120mg / 0.8ml

120 od

0.80

85

150mg / 1ml

127.5 od

0.86

90

150mg / 1ml

135 od

0.90

95

150mg / 1ml

142.5 od

0.96

weight

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
40mg Injection Enoxaparin sodium 40mg (equivalent to 4000 IU anti-Xa activity) in 0.4mL Water for
Injections
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.

ENOXAPARIN
SODIUM
Forte
syringes

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
20mg (2,000IU) 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 40mg (4,000IU) daily by subcutaneous injection with the initial dose
administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for
cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40mg (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 1.5mg/kg
(150 IU/kg). Enoxaparin sodium treatment is usually prescribed for at least 5 days and until adequate
oral anticoagulation is established.

100
150mg/ 1ml
150 od
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 1mg/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.

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

Syringe label
Kg

Injection
Dose (mg)

weight

Syringe label

Dose (mg)

weight

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

Kg

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

45

60mg / 0.6ml

45 bd

0.45

50

60mg / 0.6ml

50 bd

0.50

55

60mg / 0.6ml

55 bd

0.55

volume
(ml)

100mg/ml

60

60mg / 0.6ml

60 bd

0.60

Solution for

65

80mg / 0.8ml

65 bd

0.65

100mg/ml

40

60mg / 0.6ml

60 od

0.60

Solution for

45

80mg / 0.8ml

67.5 od

0.675

Injection

70

80mg / 0.8ml

70 bd

0.70

75

80mg / 0.8ml

75 bd

0.75

80

80mg / 0.8ml

80 bd

0.80

injection

50

80mg / 0.8ml

75 od

0.75

ENOXAPARIN
SODIUM

ENOXAPARIN
SODIUM

55

100mg / 1ml

82.5 od

0.825

syringes

syringes

60

100mg / 1ml

90 od

0.90

85

100mg / 1ml

85 bd

0.85

65

100mg / 1ml

97.5 od

0.975

90

100mg / 1ml

90 bd

0.90

95

100mg / 1ml

95 bd

0.95

100

100mg / 1ml

100 bd

1.00

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)
 Enoxaparin sodium is usually given by injection
underneath the skin (subcutaneous)
 Do not inject Enoxaparin sodium into a muscle
(intramuscular)
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.
How much will be given to you
 Your doctor will decide how much to give you.
The amount of Enoxaparin sodium 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 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
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


1
7
1
5
6
6
0
4



b) After an operation or long periods of bedrest

You should not breast-feed whilst using Enoxaparin
sodium . If you are planning to breast-feed, talk to
your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before
taking any medicine if you are pregnant or breastfeeding.

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 for 7 to 10 days. If you are going to
have an operation, your first injection will usually
be given 2 hours before your operation
 If you have a higher risk of getting a clot, you will
be given 40mg each day for 7 to 28 days. If you
are going to have an operation, your first injection
will usually be given 12 hours before your
operation
 If you are bedridden due to illness, you will be
normally be given 40mg of Enoxaparin sodium
each day for 6 to 14 days
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.
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
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
 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) Stopping blood clots forming in the tubes of
your dialysis machine
 The usual dose is 1mg 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
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.
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
5cm away from these)



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

Kg

Syringe label

Dose (mg)

weight

Dosage chart for 1mg/kg SC treatment of STEMI

Injection

Patient

volume (ml)

Injection
Kg

Syringe label

Dose (mg)

weight

volume (ml)

105

120mg / 0.8ml

105 bd

0.70

110

120mg / 0.8ml

110 bd

0.74

105

120mg / 0.8ml (1)

105 bd (1)

0.70 (1)

150mg/ml

115

120mg / 0.8ml

115 bd

0.78

110

120mg / 0.8ml (1)

110 bd (1)

0.74 (1)

Solution for

120

120mg / 0.8ml

120 bd

0.80

150mg/ml

115

120mg / 0.8ml (1)

115 bd (1)

0.78 (1)

Injection
ENOXAPARIN
SODIUM
Forte

125

150mg / 1ml

125 bd

0.84

Solution for

120

120mg / 0.8ml (1)

120 bd (1)

0.80 (1)

130

150mg / 1ml

130 bd

0.88

Injection

125

150mg / 1ml (1)

125 bd (1)

0.84 (1)

135

150mg / 1ml

135 bd

0.90

130

150mg / 1ml (1)

130 bd (1)

0.88 (1)

syringes

140

150mg / 1ml

140 bd

0.94

135

150mg / 1ml (1)

135 bd (1)

0.90 (1)

145

150mg / 1ml

145 bd

0.98

ENOXAPARIN
SODIUM
Forte
syringes

150

150mg / 1ml

150 bd

1.00

140

150mg / 1ml (1)

140 bd (1)

0.94 (1)

145

150mg / 1ml (1)

145 bd (1)

0.98 (1)

150

150mg / 1ml (1)

150 bd (1)

1.00 (1)

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg 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
Patient

Injection
Kg

Syringe label

Dose (mg)

weight

volume (ml)
40

40mg / 0.4ml

40 bd

0.40

45

60mg / 0.6ml

45 bd

0.45

50

60mg / 0.6ml

50 bd

0.50

100mg/ml

55

60mg / 0.6ml

55 bd

0.55

Solution for

60

60mg / 0.6ml

60 bd

0.60

injection
ENOXAPARIN
SODIUM
syringes

65

80mg / 0.8ml

65 bd

0.65

70

80mg / 0.8ml

70 bd

0.70

75

80mg / 0.8ml

75 bd

0.75

80

80mg / 0.8ml

80 bd

0.80

85

100mg / 1ml

85 bd

0.85

90

100mg / 1ml

90 bd

0.90

95

100mg / 1ml

95 bd

0.95

100

100mg / 1ml

100 bd

1.00

(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 1mg/kg (100IU/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 100IU/kg) may be given. For patients at a high
risk of haemorrhage the dose should be reduced to 0.5mg/kg (50IU/kg) for double vascular access or
0.75mg/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’).

4)

Instructions on injecting yourself with
Enoxaparin sodium :

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

2) Sit or lie in a comfortable
position so you are
relaxed. Make sure you
can see the place you
are going to inject.
A lounge chair,recliner,
or bed propped up
with pillows is ideal.
3) Choose an area on the right or left side of your
stomach. This should be at least 5
centimetres away from your belly button and out
towards your sides.
Remember: Do not inject yourself within 5
centimetres of your belly button or around
existing scars or bruises. Change the place
where you inject between the left and right sides
of your stomach, depending on the area you were
last injected.
4) Carefully pull off the needle cap from the
Enoxaparin sodium 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).


1
7
1
5
6
6
0
4

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
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.
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 .

5) Hold the syringe in the hand you write with (like a
pencil) and with your other hand, gently pinch the
cleaned area of your abdomen between your
forefinger and thumb to make a fold in the skin

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

8) Remove the needle by pulling it straight out. You can
now let go of the skin fold.
To avoid bruising, do not rub the injection site
after you have injected yourself.
9) Drop the used syringe into the sharps bin provided.
Close the container lid tightly and place the container
out of reach of children.
When the container is full, give it to your doctor
or home care nurse for disposal. Do not put it in
the household rubbish.
If you have too much or too little Enoxaparin sodium
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.

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 .
Uncommon (affects 1 to 10 people in a 1,000)
 Sudden severe headache. This could be a sign of
bleeding in the brain.
 A feeling of tenderness and swelling in your
stomach. You may have bleeding inside your
stomach.
Rare (affects less than 1 in a 1000 people)
 If you have an allergic reaction. The signs may
include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.


Frequency unknown
If you have had a spinal puncture or a spinal anaesthetic
and notice tingling, numbness and muscular weakness,
particularly in the lower part of your body. Also if you
lose control over your bladder or bowel (so you cannot
control when you go to the toilet).



Dosage adjustments for therapeutic dosage range
Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged ≥75 years only)
Patient
0.75mg/kg Dose
Adjusted
Injection
weight
Kg
Syringe label
(mg)
dosing (mg)
volume (ml)
40

100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes

150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
Forte
syringes

60mg / 0.6ml

45

60mg / 0.6ml

50
55

30 bd

30 bd

0.30

33.75 bd

35 bd

0.35

60mg / 0.6ml

37.5 bd

37.5 bd

0.375

60mg / 0.6ml

41.25 bd

42.5 bd

0.425

60

60mg / 0.6ml

45 bd

45 bd

0.45

65

60mg / 0.6ml

48.75 bd

50 bd

0.5

70

60mg / 0.6ml

52.5 bd

52.5 bd

0.525

75

60mg / 0.6ml

56.25 bd

57.5 bd

0.575

80

60mg / 0.6ml

60 bd

60 bd

0.60

85

80mg / 0.8ml

63.75 bd

65 bd

0.65

90

80mg / 0.8ml

67.5 bd

67.5 bd

0.675

Standard dosing

Severe renal impairment

1mg/kg SC twice daily

1mg/kg SC once daily

1.5mg/kg SC once daily

1mg/kg SC once daily

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

Severe renal impairment

40mg SC once daily

20mg SC once daily

20mg SC once daily

20mg SC once daily

95

80mg / 0.8ml

71.25 bd

72.5 bd

0.725

100

80mg / 0.8ml

75 bd

75 bd

0.75

105

80mg / 0.8ml

78.75 bd (1)

80 bd (1)

0.80 (1)

The recommended dosage adjustments do not apply to the haemodialysis indication.

110

100mg / 1ml

82.5 bd (1)

82.5 bd (1)

0.825 (1)

115

100mg / 1ml

86.25 bd (1)

87.5 bd (1)

0.875 (1)

120

100mg / 1ml

90 bd (1)

90 bd (1)

0.90 (1)

Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment
(creatinine clearance 30-50ml/min) or mild renal impairment (creatinine clearance 50-80ml/min),
careful clinical monitoring is advised.

125

100mg / 1ml

93.75 bd (1)

95 bd (1)

0.95 (1)

130

100mg / 1ml

97.5 bd (1)

97.5 bd (1)

0.975 (1)

135

120mg / 0.8ml

101.25 bd (1)

102 bd (1)

0.68 (1)

140

120mg / 0.8ml

105 bd (1)

105 bd (1)

0.7 (1)

145

120mg / 0.8ml

108.75 bd (1)

111 bd (1)

0.74 (1)

150
120mg / 0.8ml
112.5 bd (1)
114 bd (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 < 30ml/min), according to the following tables, since enoxaparin sodium exposure
is significantly increased in this patient population:

Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 ‘Special warnings and
precautions for use:’ Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4
‘Special warnings and precautions for use: Low body weight and Monitoring;’ section 5.2
‘Pharmacokinetic properties’).
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 extracorporeal 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.

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.
Frequency unknown
 Feeling tired, faint, dizzy, having pale skin. These
could be symptoms of anaemia.
 You notice yellowing of your skin or eyes and
your urine becomes darker in colour. This could
be a liver problem.
Other side effects that you should discuss with
your nurse or doctor if you are concerned about
them:
Very common (affects more than 1 in 10 people)
 Changes in the results of blood tests done to
check how your liver is working. These usually go
back to normal after you stop having Enoxaparin
sodium .
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.
Frequency unknown
 If Enoxaparin sodium is used for a long period of
time (more than 3 months), it may increase the
risk of you getting a condition called
‘osteoporosis’. This is when your bones are more
likely to break
 Headache
 Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

Blind or partially sighted?
Is this leaflet hard to see or
read?
Call 0208 515 3763 to obtain
the leaflet in a format suitable
for you.

5. How to store Enoxaparin sodium







Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
Do not use Enoxaparin sodium after the expiry
date which is stated on the carton and blister
label after ‘Exp’. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.


6. Further Information
What Enoxaparin sodium contains
The active ingredient in Enoxaparin sodium is
enoxaparin sodium.
Each pre-filled syringe contains 40mg of enoxaparin
sodium (equivalent to 4,000 IU anti-Xa activity), in
0.4ml water for injection.
The other ingredient is water for injection.
What Enoxaparin sodium looks like and contents
of the pack
Enoxaparin sodium is a clear, colourless to pale
yellow solution for injection. It comes in glass prefilled syringes fitted with an injection needle and
needle cap, contained within individual sealed blister,
blisters contained within printed carton(s).
It is supplied in pack of 10 syringes.
Manufactured by: Chinoin Pharmaceutical and
Chemical Works Private Co. Ltd., Csanyikvolgy Site
Miszkolc, Csanyikvolgy, 3510, Hungary.




Procured from within the EU and repackaged by
the Product License holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Enoxaparin sodium 40mg/0.4ml Syringes;
PL 18799/2989
Leaflet date: 18.04.2017

POM

.


1
7
1
5
6
6
0
4

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.

Required dose

Volume to inject
when diluted to a
final

(0.3mg/kg)

concentration of
3mg/ml

(Kg)

(mg)

(ml)

4.5

100

30

10

15

5

105

31.5

10.5

55

16.5

5.5

110

33

11

60

18

6

115

34.5

11.5

65

19.5

6.5

120

36

12

70

21

7

125

37.5

12.5

75

22.5

7.5

130

39

13

80

24

8

135

40.5

13.5

85

25.5

8.5

140

42

14

90

27

9

145

43.5

14.5

95

28.5

9.5

150

45

15

Required
dose

Volume to inject
when diluted to a

(0.3mg/kg)

final
concentration of
3mg/ml

(Kg)

(mg)

(ml)

45

13.5

50

Weight

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.

Weight



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 STsegment 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 pre-filled syringe into the 20ml remaining in the bag.
Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe
for administration into the intravenous line (using an appropriate injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following formula
[Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is
recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use.
Volume to be injected through intravenous line after dilution is completed

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
Solution for injection in Type I glass pre-filled syringes fitted with injection needle in packs of 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10 DATE OF REVISION OF THE TEXT
18.04.2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide