Skip to Content

UK Edition. Click here for US version.

CLEXANE 100MG/1 ML SYRINGES

Active substance(s): SODIUM ENOXAPARIN

View full screen / Print PDF » Download PDF ⇩
Transcript
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.

Product Licence holder
Procured from within the EU and repackaged by the Product Licence
holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.

S1630 LEAFLET Clexane 20160429

PACKAGE LEAFLET: INFORMATION FOR USER

CLEXANE® 20mg/0.2ml SYRINGES
CLEXANE® 40mg/0.4ml SYRINGES
CLEXANE® 60mg/0.6ml SYRINGES
CLEXANE® 80mg/0.8ml SYRINGES
CLEXANE® 100mg/1ml SYRINGES
(enoxaparin sodium)

Manufacturer
This product is manufactured by either of the below manufacturers:

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.



Sanofi Winthrop Industrie, 180 Rue Jean Jaures, 94702 MaisonsAlfort, France.



Sanofi Winthrop Industrie, Bd. Industrial, 76580 Le Trait, France

Your medicine is known by any of the above names but will be referred to
as Clexane throughout the following leaflet.



Chinoin Pharmaceutical and Chemical Works Private Co. Ltd,
Csanyikvölgy Site, Miskolc, Csanyikvölgy, H-3510 Hungary.

Read all of this leaflet carefully before you start using this medicine

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.
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. The expiry date refers to the last day of that month.



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



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.

6. Further information

POM

PL 19488/1630

Leaflet revision date: 29 April 2016

▲ You are underweight or overweight

If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist

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

The name of your medicine is Clexane 20mg, 40mg, 60mg, 80mg and
100mg Pre-filled Syringes (called Clexane in this leaflet). Clexane
contains a medicine called enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting any bigger. This helps your
body to break them down and stop them causing you harm.

Clexane can be used to:


Treat blood clots that are in your blood



Stop blood clots forming in your blood in the following situations:



After you have had a heart attack

Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an
injection needle and grey cap.



Stop blood clots forming in the tubes of your dialysis machine (used
for people with kidney problems)

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



Clexane 20mg/0.2ml Syringes have a white plunger



 You have an ulcer in your stomach or gut (intestine)

Clexane 40mg/0.4ml Syringes have a yellow plunger



 You have had a stroke caused by bleeding in the brain

Clexane 60mg/0.6ml Syringes have an orange plunger

 You have an infection in your heart



Clexane 80mg/0.8ml Syringes have a brown plunger

 You are using the medicine called heparin to treat blood clots



Clexane 100mg/1ml Syringes have a black plunger

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.

Clexane is available in packs of 10 pre-filled syringes.

Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have
recently taken any other medicines. This includes medicines you buy
without a prescription, including herbal medicines. This is because
Clexane can affect the way some other medicines work. Also some
medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your doctor if:

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

2) Stopping blood clots forming in your blood.

Each pre-filled syringe contains 40mg of enoxaparin sodium
(equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection

What Clexane looks like and contents of the pack

If you are not sure if any of the above applies to you, talk to your doctor or
pharmacist or nurse before using Clexane.

 You are using the medicine called heparin to treat blood clots



Clexane also contains water for injection.

▲ You are elderly (over 65 years old) and especially if you are aged
over 75 years old

1. What Clexane is and what it is used for

After an operation or long periods of bed rest due to illness



▲ You have recently had an operation on your eyes or brain

▲ You have any problems with your blood



Each pre-filled syringe contains 100mg of enoxaparin sodium
(equivalent to 10,000 IU anti-Xa activity) in 1ml water for injection

▲ You have ever had a stomach ulcer

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

Each pre-filled syringe contains 20mg of enoxaparin sodium
(equivalent to 2,000 IU anti-Xa activity) in 0.2ml water for injection.



▲ You have ever had a stroke

If you have any further questions, ask your doctor or pharmacist



Each pre-filled syringe contains 80mg of enoxaparin sodium
(equivalent to 8,000 IU anti-Xa activity) in 0.8ml water for injection

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



Unstable angina (where not enough blood gets to your heart)



▲ You have had a heart valve fitted





Each pre-filled syringe contains 60mg of enoxaparin sodium
(equivalent to 6,000 IU anti-Xa activity) in 0.6ml water for injection

▲ You have kidney problems

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

What Clexane contains



▲ You have high blood pressure

Keep this leaflet. You may need to read it again

Clexane is a registered trade mark of Aventis Pharma SA.
S1630 LEAFLET Clexane 20160429

Check with your doctor or pharmacist or nurse before using this
medicine if:





Is this leaflet hard to see or read? Phone 01483 505515 for help

Take special care 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.
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.

3. How to use Clexane

If you are aged 75 years or older

Having this medicine



Your doctor or nurse will give you injections of Clexane under
your skin (subcutaneous injection)

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

If you forget to use Clexane



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

The usual dose is 0.75mg for every kilogram of your weight, every
12 hours

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





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)

The maximum amount of Clexane given for the first two injections
is 75mg

If you stop using Clexane



Clexane is usually given by injection underneath the skin
(subcutaneous)



Do not inject Clexane into a muscle (intramuscular)

For patients having an operation called Percutaneous Coronary
Intervention (PCI)


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.

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)

How much will be given to you

3) Stopping blood clots forming in the tubes of your dialysis
machine



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



The usual dose is 1 mg for every kilogram of your weight



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



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

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



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

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

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)

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



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)



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





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



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)

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
fold.

If you have an allergic reaction. The signs may include: a rash,
swallowing or breathing problems, swelling of your lips, face, throat or
tongue.

Frequency unknown


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

Tell a nurse or doctor as soon as possible if you notice any of the
following side effects:
Common (affects 1 to 10 people in a 100)
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.

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.

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.

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)

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

If you are under 75 years old




Instructions on injecting yourself with Clexane:

The amount of Clexane given to you will depend on your age and the
kind of heart attack you have had.
NSTEMI type of heart attack

Bleeding a lot from a wound.

Common (affects 1 to 10 people in a 100)

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

Clexane can be used for two different types of heart attack called
NSTEMI or STEMI.

i)

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.

Like all medicines, Clexane can cause side effects, although not
everybody gets them.

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

Blood Tests

4. Possible side-effects

How to give yourself an injection of Clexane

b) After an operation or long periods of bedrest due to illness
The usual dose is 20mg or 40mg each day. The dose will depend on
how likely you are to develop a clot

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).

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.



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.

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

Rare (affects less than 1 in a 1000 people)
9) Drop the used syringe with its protective sleeve into the sharps bin
provided. Close the container lid tightly and place the container out of
reach of children.



When the container is full, give it to your doctor or home care
nurse for disposal. Do not put it in the household rubbish.
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.

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.

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

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.
S1630 LEAFLET Clexane 20160429

Volume to be injected through intravenous line after dilution is
completed

Weight

(0.3mg/kg)

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

(mg)

(ml)

Required dose

(Kg)
45

13.5

4.5

50

15

5

55

16.5

5.5

60

18

6

65

19.5

6.5

70

21

7

S1630 LEAFLET Clexane 20160429 (MIL)

THE FOLLOWING INFORMATION IS INTENDED FOR
HEALTHCARE PROFESSIONALS ONLY

CLEXANE® 20mg/0.2ml SYRINGES
CLEXANE® 40mg/0.4ml SYRINGES
CLEXANE® 60mg/0.6ml SYRINGES
CLEXANE® 80mg/0.8ml SYRINGES
CLEXANE® 100mg/1ml SYRINGES
(enoxaparin sodium)

1 NAME OF THE MEDICINAL PRODUCT

22.5

7.5

Clexane 20mg/0.2ml Syringes

80

24

8

Clexane 40mg/0.4ml Syringes

85

25.5

8.5

Clexane 60mg/0.6ml Syringes

90

27

9

Clexane 80mg/0.8ml Syringes

95

28.5

9.5

Clexane 100mg/1ml Syringes

100

30

10

105

31.5

10.5

110

33

11

115

34.5

11.5

120

36

12

125

37.5

12.5

130

39

13

135

40.5

13.5

140

42

14

145

43.5

14.5

150

45

15

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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

Injection
volume (ml)

100mg/ml

40

60mg/0.6ml

60 od

0.60

45

80mg/0.8ml

67.5 od

0.675

Injection

50

80mg/0.8ml

75 od

0.75

Clexane

55

100mg/1ml

82.5 od

0.825

syringes

60

100mg/1ml

90 od

0.90

65

100mg/1ml

97.5 od

0.975

Patient

Kg

Syringe label

Dose
(mg)

Injection
volume (ml)

70
75

120mg/0.8ml

105 od

0.70

120mg/0.8ml

112.5 od

0.76

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

100

150mg/1ml

150 od

1.00

weight
150mg/ml
Solution
for
Injection
Clexane
Forte
syringes

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.

80 mg Injection Enoxaparin sodium 80 mg (equivalent to 8,000 IU
anti-Xa activity) in 0.8 mL Water for Injections

Treatment of unstable angina and non-Q-wave myocardial
infarction

100 mg Injection Enoxaparin sodium 100mg (equivalent to 10,000
IU anti-Xa activity) in 1.0 mL Water for Injections

The recommended dose is 1mg/kg Clexane every 12 hours by
subcutaneous injection, administered concurrently with oral aspirin
(100 to 325mg once daily).

3 PHARMACEUTICAL FORM

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.

Solution for injection.
Clear, colourless to pale yellow solution.

6.2 Incompatibilities

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

Kg

Syringe
label

Dose
(mg)

Injection
volume (ml)

40

40mg/0.4ml

40 bd

0.40

45

60mg/0.6ml

45 bd

0.45

Prophylaxis of venous thromboembolism:

50

60mg/0.6ml

50 bd

0.50

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.

55

60mg/0.6ml

55 bd

0.55

100mg/ml

60

60mg/0.6ml

60 bd

0.60

Solution
for

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

Subcutaneous Injection

4.2 Posology and method of administration

Clexane should not be mixed with any other injections or
infusions.

Adults:

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 carton
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 and an automatic safety device in packs of
2, 10 and 20.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.

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.

weight

Injection
Clexane
syringes

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

Kg

Syringe label

Dose
(mg)

Injection
volume (ml)

150mg/ml
Solution
for

105

120mg/0.8ml

105 bd

0.70

110

120mg/0.8ml

110 bd

0.74

115

120mg/0.8ml

115 bd

0.78

120

120mg/0.8ml

120 bd

0.80

125

150mg/1ml

125 bd

0.84

130

150mg/1ml

130 bd

0.88

135

150mg/1ml

135 bd

0.90

140

150mg/1ml

140 bd

0.94

145

150mg/1ml

145 bd

0.98

150

150mg/1ml

150 bd

1.00

Injection
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
POM

Dose
(mg)

Solution for

Pre-filled syringes:

PHARMACEUTICAL PARTICULARS
Water for Injections

Syringe
label

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

75

6.1 List of excipients

Kg

weight

The following information is extracted from the SPC
Technical information for the administration of Clexane
Syringes

For full list of excipients, see section 6.1
6

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

PL 19488/1630

Leaflet revision date: 29 April 2016
S1630 LEAFLET Clexane 20160429 (MIL)

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.

Clexane
Forte
syringes

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

Kg

Syringe
label

Dose
(mg)

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

Prevention of extracorporeal thrombus formation during
haemodialysis:
A dose equivalent to 1mg/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 0.5mg/kg (50 IU/kg) for double vascular
access or 0.75mg/kg (75 IU/kg) for single vascular access.

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).

55

60mg/0.6ml

55 bd

0.55

60

60mg/0.6ml

60 bd

0.60

Solution
for

65

80mg/0.8ml

65 bd

0.65

70

80mg/0.8ml

70 bd

0.70

75

80mg/0.8ml

75 bd

0.75

Patient

80

80mg/0.8ml

80 bd

0.80

weight

Injection
Clexane
syringes

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

Dosage chart for 1mg/kg SC treatment of STEMI
Patient

Kg

Syringe label

weight

150mg/ml
Solution
for
Injection
Clexane
Forte
syringes

Dose
(mg)

Injection
volume
(ml)

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

Elderly:

100mg/ml

Renal impairment: (See also section 4.4 Special warnings and
precautions for use: Renal impairment and Monitoring; section 5.2
Pharmacokinetic properties).

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

Syringe
label

0.75mg/kg
Dose (mg)

Adjusted
dosing
(mg)

Injection
volume
(ml)

Severe renal impairment
1 mg/kg SC once daily

Note: The plunger has to be pressed down all the way for the safety
device to be activated.

1.5 mg/kg SC once daily

1 mg/kg SC once daily

Do not rub the injection site after administration.

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.

30mg-single IV bolus plus a
1mg/kg SC dose followed by
1mg/kg once daily.

(Max 100mg for each of the first
two SC doses)

(Max 100mg for first SC dose
only)

For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily
without initial bolus.

1mg/kg SC once daily without
initial bolus.

(Max 75mg for each of the first
two SC doses)

(Max 100mg for first SC dose
only)

20 mg SC once daily



20 mg SC once daily

20 mg SC once daily

0.30

35 bd

0.35

50

60mg/0.6ml

37.5 bd

37.5 bd

0.375

100mg/ml

55

60mg/0.6ml

41.25 bd

42.5 bd

0.425

Solution
for

60

60mg/0.6ml

45 bd

45 bd

0.45

65

60mg/0.6ml

48.75 bd

50 bd

0.5

Injection

70

60mg/0.6ml

52.5 bd

52.5 bd

0.525

Clexane

Moderate and mild renal impairment:

75

60mg/0.6ml

56.25 bd

57.5 bd

0.575

syringes

80

60mg/0.6ml

60 bd

60 bd

0.60

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

105

120mg/0.8ml (1)

105 bd (1)

0.70 (1)

110

120mg/0.8ml (1)

110 bd (1)

0.74 (1)

115

120mg/0.8ml (1)

115 bd (1)

0.78 (1)

85

80mg/0.8ml

63.75 bd

65 bd

0.65

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.

120

120mg/0.8ml (1)

120 bd (1)

0.80 (1)

90

80mg/0.8ml

67.5 bd

67.5 bd

0.675

Spinal/epidural anaesthesia:

125

150mg/1ml (1)

125 bd (1)

0.84 (1)

95

80mg/0.8ml

71.25 bd

72.5 bd

0.725

130

150mg/1ml (1)

130 bd (1)

0.88 (1)

100

80mg/0.8ml

75 bd

75 bd

0.75

135

150mg/1ml (1)

135 bd (1)

0.90 (1)

105

80mg/0.8ml

78.75 bd (1)

80 bd (1)

0.80 (1)

For patients receiving spinal/epidural anaesthesia see section 4.4
Special warnings and precautions for use: Spinal/epidural
anaesthesia

0.94 (1)

110

100mg/1ml

82.5 bd (1)

82.5 bd (1)

0.825 (1)

0.98 (1)

115

100mg/1ml

86.25 bd (1)

87.5 bd (1)

0.875 (1)

150

150mg/1ml (1)

150 bd (1)

1.00 (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)

150mg/ml

135

120mg/0.8ml

101.25 bd (1)

102 bd (1)

0.68 (1)

Solution
for
Injection

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)

120mg/0.8ml

112.5 bd (1)

114 bd (1)

0.76 (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.

Clexane
Forte
syringes

150

(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.

Initial 30mg bolus

40 mg SC once daily

30 bd

145 bd (1)



Severe renal impairment

30 bd
33.75 bd

140 bd (1)

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.

Standard dosing

Dosage adjustments for prophylactic dosage ranges

60mg/0.6ml

150mg/1ml (1)

Intravenous (Bolus) Injection Technique (for acute STEMI indication
only):

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.

60mg/0.6ml

150mg/1ml (1)

Once the plunger is fully pressed down the safety device is
activated automatically. This protects the used needle.

Standard dosing

45

145

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.

1 mg/kg SC twice daily

40

140

Subcutaneous injection technique

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-Qwave 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

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.
S1630 LEAFLET Clexane 20160429 (MIL)

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

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

Hide