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ENOXAPARIN SODIUM 100MG/1ML SYRINGES

Active substance(s): ENOXAPARIN SODIUM

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Package Leaflet: Information for the user

Clexane® 100mg/1ml Syringes
(enoxaparin sodium)

Read all of this leaflet carefully before you start using this medicine
 Keep this leaflet. You may need to read it again
 If you have any further questions, ask your doctor 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
 Clexane is also available in different strengths

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)

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 and dispose of Clexane
6. Further information

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. What Clexane is and what it is used for
The name of your medicine is Clexane® 100mg/1ml 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.

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

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.

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

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)

a) Unstable angina
 The usual dose is 1mg for every kilogram of your 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 bed rest due to illness
The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are to develop a clot
 If you have a low to medium risk of getting a clot, you will be given
20mg of Clexane 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 given 40mg
of Clexane each day for 6 to 14 days

2. Before you use Clexane
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

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

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
 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

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

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.

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)

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

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.

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.

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)

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.
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 breast-feeding.



THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
®

Clexane 20mg, 40mg, 60mg, 80mg and 100mg Syringes
(enoxaparin sodium)

The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
1 NAME OF THE MEDICINAL PRODUCT
Clexane® Syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
20 mg Injection Enoxaparin sodium 20 mg (equivalent to 2,000 IU anti-Xa activity) in 0.2 mL Water for Injections
40 mg Injection Enoxaparin sodium 40 mg (equivalent to 4,000 IU anti-Xa activity) in 0.4 mL Water for Injections
60 mg Injection Enoxaparin sodium 60 mg (equivalent to 6,000 IU anti-Xa activity) in 0.6 mL Water for Injections
80 mg Injection Enoxaparin sodium 80 mg (equivalent to 8,000 IU anti-Xa activity) in 0.8 mL Water for Injections
100 mg Injection Enoxaparin sodium 100 mg (equivalent to 10,000 IU anti-Xa activity) in 1 mL Water for Injections
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for
7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours preoperatively. In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the
initial dose administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for cancer and are not otherwise at risk for
major bleeding complications, the recommended dosage is 40 mg (4,000 IU) once daily by subcutaneous injection for 4 weeks with the initial dose
administered approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for
a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least
5 days and until adequate oral anticoagulation is established.
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
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

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

150mg/ml
Solution for
Injection
CLEXANE
Forte
syringes

Dose (mg)

Injection
volume (ml)

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

105 od
112.5 od
120 od

0.70
0.76
0.80

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

127.5 od
135 od
142.5 od
150 od

0.86
0.90
0.96
1.00

Kg

Syringe label

70
75
80
85
90
95
100

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325mg once
daily). Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of
treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient
weight

100mg/ml
Solution for
Injection
CLEXANE
syringes

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

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

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

85
90
95
100

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

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

Patient
weight

150mg/ml
Solution for
Injection
CLEXANE
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.
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
weight

100mg/ml
Solution for
Injection
CLEXANE
syringes

Dosage chart for 1mg/kg SC treatment of STEMI

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

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

85
90
95
100

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

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

Patient
weight

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

100mg/ml
Solution for Injection
CLEXANE syringes

150mg/ml
Solution for Injection
CLEXANE Forte syringes

(elderly patients aged ≥75 years only)

Kg

Syringe label

0.75mg/kg Dose (mg)

Adjusted dosing (mg)

Injection volume (ml)

40
45
50
55
60
65
70
75
80

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

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

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

0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60

85
90
95
100
105

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

63.75 bd
67.5 bd
71.25 bd
75 bd
78.75 bd (1)

65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)

0.65
0.675
0.725
0.75
0.80 (1)

110
115
120
125
130

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

82.5 bd (1)
86.25 bd (1)
90 bd (1)
93.75 bd (1)
97.5 bd (1)

82.5 bd (1)
87.5 bd (1)
90 bd (1)
95 bd (1)
97.5 bd (1)

0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)

135
140
145
150

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

101.25 bd (1)
105 bd (1)
108.75 bd (1)
112.5 bd (1)

102 bd (1)
105 bd (1)
111 bd (1)
114 bd (1)

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

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.

Instructions on injecting yourself with Clexane:
1) Wash your hands and the area that you will inject with soap and water.
Dry them.

4. Possible side effects
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.
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.

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.

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.

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).

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.

Tell a nurse or doctor as soon as possible if you notice any of the
following side effects:

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

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

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).

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.

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

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

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store and dispose of Clexane
 Keep out of the sight and reach of children.
 Do not use Clexane after the expiry date which is stated on the syringe
label and on the carton. The expiry date refers to the last day of that
month.
 Do not store above 25oC. Do not refrigerate or freeze.
 If your syringes become discoloured or show any signs of
deterioration, return them to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. If you are using this medicine at home you will be given a
container (a sharps bin) to use for disposal. Return the sharps bin or
any used or unused syringes to your doctor or nurse or pharmacist for
disposal. These measures will help to protect the environment.

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

6. Further Information
What Clexane contains
 Each pre-filled syringe contains 100mg of Enoxaparin sodium
(equivalent to 10,000 I.U. anti-Xa activity) in 1ml water for injection.
 The other ingredient is water for injections.
What Clexane looks like and contents of the pack
Clexane is a clear, colourless to pale yellow solution for injection in a
Type I glass pre-filled syringe fitted with an injection needle, needle cap
and an automatic safety device contained within individual sealed blister,
blisters contained within printed carton.
Clexane Syringes are supplied in packs of 10.

Note: the safety system allowing release of the protective sleeve, can
only be activated when the syringe has been emptied by pressing the
plunger all the way down.
To avoid bruising, do not rub the injection site after you have
injected yourself.

Manufactured by
Sanofi Winthrop Industrie, 180, rue Jean Jaures, 94702 Maisons-Alfort,
France.

9) Drop the used syringe with its protective sleeve into the sharps bin
provided. Close the container lid tightly and place the container out of
reach of children.

Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait, France.
CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd
Csanyikvolgy Site Miskolc, Csanyikvolgy, H-3510 Hungary.

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.

Procured from within the EU by MPT Pharma Ltd, Westgate Business
Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK.

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

Leaflet dated 2nd February 2016
Leaflet coded xxxxxxxxxxxxxxx

Repackaged by MPT Pharma Ltd
PL:33532/0514

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

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.

POM


(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment and Monitoring; section 5.2 Pharmacokinetic
properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min), according to the following tables, since
enoxaparin sodium exposure is significantly increased in this patient population:
Dosage adjustments for therapeutic dosage range
Standard dosing

Severe renal impairment

1 mg/kg SC twice daily

1 mg/kg SC once daily

1.5 mg/kg SC once daily

1 mg/kg SC once daily

For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg twice daily.
(Max 100mg for each of the first two SC doses)

30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg once daily.
(Max 100mg for first SC dose only)

For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial bolus.
(Max 75mg for each of the first two SC doses)

1mg/kg SC once daily without initial bolus.
(Max 100mg for first SC dose only)

Dosage adjustments for prophylactic dosage ranges
Standard dosing

Severe renal impairment

40 mg SC once daily

20 mg SC once daily

20 mg SC once daily

20 mg SC once daily

The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment
(creatinine clearance 50-80 ml/min), careful clinical monitoring is advised.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 Special warnings and precautions for use: Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4 Special warnings and precautions for use: Low body weight
and Monitoring; section 5.2 Pharmacokinetic properties).
Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic disease, treatment of deep vein thrombosis or for the
treatment of unstable angina, non-Q-wave myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial line of a dialysis
circuit for the prevention of thrombus formation in the extra-corporeal circulation during haemodialysis; and via intravenous (bolus) injection through an
intravenous line only for the initial dose of acute STEMI indication and before PCI when needed. It must not be administered by the intramuscular route.
To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic safety device.
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be administered when the patient is lying down by deep subcutaneous injection.
The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall. The whole length of the needle should be
introduced vertically into a skin fold held between the thumb and index finger. The skin fold should not be released until the injection is complete.
Once the plunger is fully pressed down the safety device is activated automatically. This protects the used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be used. Enoxaparin sodium should be administered
through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with all
other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous
bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or
5% dextrose in water.
 Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or 100mg), expel the excessive volume to retain only
30mg (0.3ml) in the syringe. The 30mg dose can then be directly injected into an injection site in the intravenous line.
 Additional bolus for PCI when last SC administration was given more than 8 hours before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3mg/kg is to be administered if last SC administration
was given more than 8 hours before balloon inflation (see section 4.2 Posology and method of administration: Treatment of acute ST-segment Elevation
Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to use a 50ml infusion bag (i.e. using either normal saline
solution (0.9%) or 5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60mg enoxaparin sodium prefilled syringe into
the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for administration into the
intravenous line (using an appropriate injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (ml) = Patient
weight (kg) x 0.1] or using the table below. It is recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use.
Volume to be injected through intravenous line after dilution is completed
Weight

Required dose
(0.3mg/kg)

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

Weight

Required dose
(0.3mg/kg)

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

(Kg)

(mg)

(ml)

(Kg)

(mg)

(ml)

45

13.5

4.5

100

30

10

50

15

5

105

31.5

10.5

55

16.5

5.5

110

33

11

60

18

6

115

34.5

11.5

65

19.5

6.5

120

36

12

70

21

7

125

37.5

12.5

75

22.5

7.5

130

39

13

80

24

8

135

40.5

13.5

85

25.5

8.5

140

42

14

90

27

9

145

43.5

14.5

95

28.5

9.5

150

45

15

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
6.2 Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose in water.
6.3 Shelf life
See expiry date on the carton.
6.4 Special precautions for storage
Do not store above 25oC. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers - discard any unused product.
6.5 Nature and contents of container
Clexane is a clear, colourless to pale yellow solution for injection in a Type I glass pre-filled syringe fitted with an injection needle,
needle cap and an automatic safety device contained within individual sealed blister, blisters contained within printed carton.
Clexane Syringes are supplied in packs of 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
10 DATE OF REVISION OF THE TEXT
20/11/2015

Package Leaflet: Information for the user

Enoxaparin Sodium 100mg/1ml Syringes
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
 Enoxaparin Sodium is also available in different strengths

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)

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 and dispose of Enoxaparin Sodium
6. Further information

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.

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

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

The name of your medicine is Enoxaparin Sodium 100mg/1ml 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.

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

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)

2) Stopping blood clots forming in your blood in the following
situations:
a) Unstable angina
 The usual dose is 1mg for every kilogram of your weight, every
12 hours
 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 bed rest due to illness
The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are to develop a clot
 If you have a low to medium risk of getting a clot, you will be given
20mg of 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 given 40mg
of Enoxaparin Sodium each day for 6 to 14 days

2. Before you use Enoxaparin Sodium
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

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.

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.

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

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

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

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.

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)

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

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.

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.

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)

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.
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 breast-feeding.



THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

Enoxaparin Sodium 20mg, 40mg, 60mg, 80mg and 100mg Syringes
The following information is extracted from the SPC
Technical information for the administration of Enoxaparin Sodium Syringes
1 NAME OF THE MEDICINAL PRODUCT
Enoxaparin Sodium Syringes
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
20 mg Injection Enoxaparin sodium 20 mg (equivalent to 2,000 IU anti-Xa activity) in 0.2 mL Water for Injections
40 mg Injection Enoxaparin sodium 40 mg (equivalent to 4,000 IU anti-Xa activity) in 0.4 mL Water for Injections
60 mg Injection Enoxaparin sodium 60 mg (equivalent to 6,000 IU anti-Xa activity) in 0.6 mL Water for Injections
80 mg Injection Enoxaparin sodium 80 mg (equivalent to 8,000 IU anti-Xa activity) in 0.8 mL Water for Injections
100 mg Injection Enoxaparin sodium 100 mg (equivalent to 10,000 IU anti-Xa activity) in 1 mL Water for Injections
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for
7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours preoperatively. In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the
initial dose administered approximately 12 hours before surgery.
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for cancer and are not otherwise at risk for
major bleeding complications, the recommended dosage is 40 mg (4,000 IU) once daily by subcutaneous injection for 4 weeks with the initial dose
administered approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for
a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
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.
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient weight

100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes

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

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

Patient weight

150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes

Dose (mg)

Injection
volume (ml)

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

105 od
112.5 od
120 od

0.70
0.76
0.80

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

127.5 od
135 od
142.5 od
150 od

0.86
0.90
0.96
1.00

Kg

Syringe label

70
75
80
85
90
95
100

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg 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 weight

100mg/ml
Solution
for Injection
ENOXAPARIN
SODIUM
syringes

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

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

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

85
90
95
100

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

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

Patient weight

150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
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.
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 weight

100mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
syringes

Dosage chart for 1mg/kg SC treatment of STEMI

Kg

Syringe label

Dose (mg)

Injection
volume (ml)

40

40mg / 0.4ml

40 bd

0.40

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

85
90
95
100

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

85 bd
90 bd
95 bd
100 bd

0.85
0.90
0.95
1.00

Patient weight

150mg/ml
Solution for
Injection
ENOXAPARIN
SODIUM
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).
Dosage chart for 0.75mg/kg SC treatment of STEMI
Patient weight

100mg/ml
Solution for Injection
ENOXAPARIN SODIUM
syringes

150mg/ml
Solution for Injection
ENOXAPARIN SODIUM
syringes

(elderly patients aged ≥75 years only)

Kg

Syringe label

0.75mg/kg Dose (mg)

Adjusted dosing (mg)

Injection volume (ml)

40
45
50
55
60
65
70
75
80

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

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

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

0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60

85
90
95
100
105

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

63.75 bd
67.5 bd
71.25 bd
75 bd
78.75 bd (1)

65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)

0.65
0.675
0.725
0.75
0.80 (1)

110
115
120
125
130

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

82.5 bd (1)
86.25 bd (1)
90 bd (1)
93.75 bd (1)
97.5 bd (1)

82.5 bd (1)
87.5 bd (1)
90 bd (1)
95 bd (1)
97.5 bd (1)

0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)

135
140
145
150

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

101.25 bd (1)
105 bd (1)
108.75 bd (1)
112.5 bd (1)

102 bd (1)
105 bd (1)
111 bd (1)
114 bd (1)

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

Instructions on injecting yourself with Enoxaparin Sodium:

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.

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

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.
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.

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.

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.

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).

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.

Tell a nurse or doctor as soon as possible if you notice any of the
following side effects:

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.

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

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).

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.

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

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

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

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store and dispose of 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 syringe label and on the carton. The expiry date refers to the last
day of that month.
 Do not store above 25oC. Do not refrigerate or freeze.
 If your syringes become discoloured or show any signs of
deterioration, return them to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. If you are using this medicine at home you will be given a
container (a sharps bin) to use for disposal. Return the sharps bin or
any used or unused syringes to your doctor or nurse or pharmacist for
disposal. These measures will help to protect the environment.

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

6. Further Information
What Enoxaparin Sodium contains
 Each pre-filled syringe contains 100mg of Enoxaparin sodium
(equivalent to 10,000 I.U. anti-Xa activity) in 1ml water for injection.
 The other ingredient is water for injections.
What Enoxaparin Sodium looks like and contents of the pack
Enoxaparin Sodium is a clear, colourless to pale yellow solution for
injection in a Type I glass pre-filled syringe fitted with an injection needle,
needle cap and an automatic safety device contained within individual
sealed blister, blisters contained within printed carton.
Enoxaparin Sodium Syringes are supplied in packs of 10.

Note: the safety system allowing release of the protective sleeve, can
only be activated when the syringe has been emptied by pressing the
plunger all the way down.
To avoid bruising, do not rub the injection site after you have
injected yourself.

Manufactured by
Sanofi Winthrop Industrie, 180, rue Jean Jaures, 94702 Maisons-Alfort,
France.

9) Drop the used syringe with its protective sleeve into the sharps bin
provided. Close the container lid tightly and place the container out of
reach of children.

Sanofi Winthrop Industrie, Boulevard Industriel, 76580 Le Trait, France.
CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd
Csanyikvolgy Site Miskolc, Csanyikvolgy, H-3510 Hungary.

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.

Procured from within the EU by MPT Pharma Ltd, Westgate Business
Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK.

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

Leaflet dated 2nd February 2016
Leaflet coded xxxxxxxxxxxxxxx

Repackaged by MPT Pharma Ltd
PL:33532/0514

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.

POM


(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes
recommended in this table have been rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment and Monitoring; section 5.2 Pharmacokinetic
properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min), according to the following tables, since
enoxaparin sodium exposure is significantly increased in this patient population:
Dosage adjustments for therapeutic dosage range
Standard dosing

Severe renal impairment

1 mg/kg SC twice daily

1 mg/kg SC once daily

1.5 mg/kg SC once daily

1 mg/kg SC once daily

For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg twice daily.
(Max 100mg for each of the first two SC doses)

30mg-single IV bolus plus a 1mg/kg SC dose
followed by 1mg/kg once daily.
(Max 100mg for first SC dose only)

For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial bolus.
(Max 75mg for each of the first two SC doses)

1mg/kg SC once daily without initial bolus.
(Max 100mg for first SC dose only)

Dosage adjustments for prophylactic dosage ranges
Standard dosing

Severe renal impairment

40 mg SC once daily

20 mg SC once daily

20 mg SC once daily

20 mg SC once daily

The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment
(creatinine clearance 50-80 ml/min), careful clinical monitoring is advised.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section 4.4 Special warnings and precautions for use: Spinal/epidural anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section 4.4 Special warnings and precautions for use: Low body weight
and Monitoring; section 5.2 Pharmacokinetic properties).
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.
To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic safety device.
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. 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.
Once the plunger is fully pressed down the safety device is activated automatically. This protects the used needle.
Note: The plunger has to be pressed down all the way for the safety device to be activated.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be used. Enoxaparin sodium should be administered
through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with all
other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous
bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or
5% dextrose in water.
 Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or 100mg), expel the excessive volume to retain only
30mg (0.3ml) in the syringe. The 30mg dose can then be directly injected into an injection site in the intravenous line.
 Additional bolus for PCI when last SC administration was given more than 8 hours before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3mg/kg is to be administered if last SC administration
was given more than 8 hours before balloon inflation (see section 4.2 Posology and method of administration: Treatment of acute ST-segment Elevation
Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to use a 50ml infusion bag (i.e. using either normal saline
solution (0.9%) or 5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60mg enoxaparin sodium prefilled syringe into
the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for administration into the
intravenous line (using an appropriate injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (ml) = Patient
weight (kg) x 0.1] or using the table below. It is recommended to prepare the dilution immediately before use and to discard any remaining solution
immediately after use.
Volume to be injected through intravenous line after dilution is completed
Weight

Required dose
(0.3mg/kg)

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

Weight

Required dose
(0.3mg/kg)

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

(Kg)

(mg)

(ml)

(Kg)

(mg)

(ml)

45

13.5

4.5

100

30

10

50

15

5

105

31.5

10.5

55

16.5

5.5

110

33

11

60

18

6

115

34.5

11.5

65

19.5

6.5

120

36

12

70

21

7

125

37.5

12.5

75

22.5

7.5

130

39

13

80

24

8

135

40.5

13.5

85

25.5

8.5

140

42

14

90

27

9

145

43.5

14.5

95

28.5

9.5

150

45

15

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for injections
6.2 Incompatibilities
Subcutaneous Injection
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
See expiry date on the carton.
6.4 Special precautions for storage
Do not store above 25oC. 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
Enoxaparin Sodium is a clear, colourless to pale yellow solution for injection in a Type I glass pre-filled syringe fitted with an injection needle,
needle cap and an automatic safety device contained within individual sealed blister, blisters contained within printed carton.
Enoxaparin Sodium Syringes are supplied in packs of 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
10 DATE OF REVISION OF THE TEXT
20/11/2015

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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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