CLEXANE 100MG/1 ML SYRINGES

Active substance: SODIUM ENOXAPARIN

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

6. Further information

Common (affects 1 to 10 people in a 100)



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



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



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

PACKAGE LEAFLET: INFORMATION FOR THE USER

What Clexane contains

You bruise more easily than usual. This could be because of a
blood problem (thrombocytopenia).



S1630 LEAFLET Clexane 20121026



Each pre-filled syringe contains 60mg of enoxaparin sodium
(equivalent to 6,000 IU anti-Xa activity) in 0.6ml water for
injection
Each pre-filled syringe contains 80mg of enoxaparin sodium
(equivalent to 8,000 IU anti-Xa activity) in 0.8ml water for
injection



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

Other side effects that you should discuss with your nurse or
doctor if you are concerned about them:



Clexane also contains water for injection.

Very common (affects more than 1 in 10 people)

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

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

What Clexane looks like and contents of the pack



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)

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 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



Clexane 20mg/0.2ml Syringes have a white plunger

2. Before you use Clexane



Clexane 40mg/0.4ml Syringes have a yellow plunger

3. How to use Clexane



Clexane 60mg/0.6ml Syringes have an orange plunger

4. Possible side-effects



Clexane 80mg/0.8ml Syringes have a brown plunger

5. How to store Clexane



Clexane 100mg/1ml Syringes have a black plunger

6. Further information

Clexane is available in packs of 10 pre-filled syringes.
1. What Clexane is and what it is used for
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.

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 a illness known as ‘diabetic
retinopathy’ (problems with the blood vessels in the eye caused
by diabetes)
 You have any problems with your blood
 You are underweight or overweight
 You are elderly (over 65 years old) and especially if you are
aged over 75 years old
If you are not sure if any of the above applies to you, talk to your
doctor or pharmacist or nurse before using Clexane.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are taking or
have recently taken any other medicines. This includes medicines
you buy without a prescription, including herbal medicines. This is
because Clexane can affect the way some other medicines work.
Also some medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your doctor if:
 You are using the medicine called heparin to treat blood clots
Tell your doctor if you are taking any of the following
medicines:

5. How to store Clexane

Manufacturer

The name of your medicine is Clexane 20mg/0.2ml Syringes,
Clexane 40mg/0.4ml Syringes, Clexane 60mg/0.6ml Syringes,
Clexane 80mg/0.8ml Syringes and 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.



Dextran injection - used as a blood replacer



This product is manufactured by either of the below manufacturers:

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.

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

2) Stopping blood clots forming in your blood.



Water tablets (diuretics) such as spironolactone, triamterene or
amiloride. These may increase the levels of potassium in your
blood when taken with Clexane



If Clexane is used for a long period of time, it may increase the
risk of you getting a condition called ‘osteoporosis’. This is
when your bones are more likely to break

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.



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



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





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.

Sanofi Winthrop Industrie, 180 Rue Jean Jaures, 94702
Maisons- Alfort, France.

POM

PL No: 19488/1630

Leaflet revision date: 26 October 2012

Clexane can be used to:


Treat blood clots that are in your blood



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

Clexane is a registered trademark of Aventis Pharma SA.



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




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



S1630 LEAFLET Clexane 20121026

After you have had a heart attack

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



Warfarin - used for thinning the blood



Aspirin, dipyridamole, clopidogrel or other medicines - used to
stop blood clots forming

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.

2. Before you use Clexane

Pregnancy and breast-feeding

Do not have this medicine and tell your doctor, pharmacist or
nurse if:

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

 You are allergic (hypersensitive) to enoxaparin sodium or any of
the other ingredients of Clexane (listed in Section 6: Further
information)

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.

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

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





Before you use Clexane your doctor or nurse may carry out a
blood test

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





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





When you go home you may need to continue to use Clexane
and give it to yourself (see below instructions on how to do this)



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

If you are not sure why you are receiving Clexane or have any
questions about how much Clexane is being given to you, speak to
your doctor, pharmacist or nurse.
How much will be given to you


Your doctor will decide how much to give you. The amount of
Clexane given to you will depend on the reason it is being used



If you have problems with your kidneys, you may be given a
smaller amount of Clexane
1) Treating blood clots that are in your blood


The usual dose is 1.5mg for every kilogram of your weight,
each day

 Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in the following
situations:

The maximum amount of Clexane given for the first two
injections is 75mg
For patients having an operation called Percutaneous
Coronary Intervention (PCI)


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.

9) Drop the used syringe with its cap 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.

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

If you have more Clexane than you should

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)

If you forget to use Clexane

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


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

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

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



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.

Do not press on the plunger before injecting yourself to get rid of air
bubbles. This can lead to a loss of the medicine. Once you have
removed the cap, do not allow the needle to touch anything. This is
to make sure the needle stays clean (sterile).
5) Hold the syringe in the hand you write with (like a pencil) and
with your other hand, gently pinch the cleaned area of your
abdomen between your forefinger and thumb to make a fold in
the skin

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. If you are going to have an
operation, your first injection will usually be given 2 hours
before your operation
If you have a higher risk of getting a clot, you will be given
40mg each day. If you are going to have an operation, your first
injection will usually be given 12 hours before your operation
If you are bedridden due to illness, you will be normally be
given 40mg of Clexane each day for 6 to 14 days

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.



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.



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)

Instructions on injecting yourself with Clexane:

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)
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 finger. This will send the
medication into the fatty tissue of the stomach. Make sure you
hold the skin fold throughout the injection.

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



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.



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).

ii) STEMI type of heart attack


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)



The maximum amount of Clexane given for the first two
injections is 100mg



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

Then you will be given 1mg for every kilogram of your weight
every 12 hours after that



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.

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)

Clexane will usually be given for 2 to 8 days. Your doctor will
normally ask you to take aspirin as well

If you are under 75 years old

Bleeding a lot from a wound.

Common (affects 1 to 10 people in a 100)

The usual amount is 1mg for every kilogram of weight, every
12 hours



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.

4. Possible side-effects

Check the expiry date on the medicine. Do not use if the date
has passed

i) NSTEMI type of heart attack


If you stop using Clexane

Before injecting yourself with 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

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.

The injections will normally be given for up to 8 days
To avoid bruising, do not rub the injection site after you have
injected yourself.

S1630 LEAFLET Clexane 20121026

Volume to be injected through intravenous line after dilution is
completed

6 PHARMACEUTICAL PARTICULARS
Water for Injections

Weight

Required dose
(0.3mg/kg)

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

(Kg)

(mg)

(ml)

45

13.5

4.5

50

15

5

55

16.5

5.5

60

18
19.5

6.5

70

21

7

75

22.5
24

8

85

25.5

8.5

90

27

9

95

28.5

9.5

100

30

10

105

31.5

10.5

110

33

11

115

34.5

Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only

7.5

80

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)

6.2 Incompatibilities

6

65

S1630 LEAFLET Clexane 20121026 (MIL)

THE FOLLOWING INFORMATION IS INTENDED FOR
HEALTHCARE PROFESSIONALS ONLY

6.1 List of excipients

Enoxaparin sodium may be safely administered with normal saline
solution (0.9%) or 5% in dextrose in water.

Technical information for the administration of Clexane
Syringes

36 months

Syringe
label

Dose
(mg)

Injection
volume (ml)

100mg/ml

40

60mg/0.6ml

60 od

0.60

Solution for

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

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

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

1 NAME OF THE MEDICINAL PRODUCT
Clexane 20mg/0.2ml Syringes
Clexane 40mg/0.4ml Syringes

6.5 Nature and contents of container

Injection
Clexane

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

Clexane 20mg/0.2ml Syringes have a white plunger

Syringe label

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

150mg/1ml

150 od

1.00

Pre-filled syringes:
Enoxaparin sodium 20mg (equivalent to 2,000 IU anti-Xa activity) in
0.2ml water for injection.

syringes

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

11.5

Dose
(mg)

100

150mg/ml
Solution
for

Clexane 60mg/0.6ml Syringes
Clexane 100mg/1ml Syringes

Kg

weight

Clexane 80mg/0.8ml Syringes

36

12

-

Clexane 40mg/0.4ml Syringes have a yellow plunger

125

37.5

12.5

-

Clexane 60mg/0.6ml Syringes have an orange plunger

130

39

13

-

Clexane 80mg/0.8ml Syringes have a brown plunger

135

40.5

13.5

-

Clexane 100mg/1ml Syringes have a black plunger

140

42

14

145

43.5

14.5

45

Kg

weight

The following information is extracted from the SPC
6.3 Shelf life

120

150

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

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

15

Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in
0.4ml water for injection.

Clexane is available in packs of 10 pre-filled syringes

Enoxaparin sodium 60mg (equivalent to 6,000 IU anti-Xa activity) in
0.6ml water for injection.

6.6 Special precautions for disposal

Enoxaparin sodium 80mg (equivalent to 8,000 IU anti-Xa activity) in
0.8ml water for injection.

See section 4.2 Posology and method of administration.

Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity)
in 1ml water for injection.

Product Licence holder

For full list of excipients, see section 6.1

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

3 PHARMACEUTICAL FORM

POM

PL No: 19488/1630

Leaflet revision date: 26 October 2012
S1630 LEAFLET Clexane 20121026 (MIL)

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

Solution for injection.

Patient

Clear, colourless solution.

weight

Kg

Syringe
label

Dose
(mg)

Injection
volume (ml)

40

40mg/0.4ml

40 bd

0.40

4.2 Posology and method of administration

45

60mg/0.6ml

45 bd

0.45

Adults:

50

60mg/0.6ml

50 bd

0.50

Prophylaxis of venous thromboembolism:

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

Prophylaxis of venous thromboembolism in medical patients:

95

100mg/1ml

95 bd

0.95

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.

100

100mg/1ml

100 bd

1.00

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.

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.

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
Clexane
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

When administered in conjunction with a thrombolytic (fibrin specific
or non-fibrin specific) enoxaparin sodium should be given between
15 minutes before and 30 minutes after the start of fibrinolytic
therapy. All patients should receive acetylsalicylic acid (ASA) as
soon as they are identified as having STEMI and maintained under
(75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8
days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention
(PCI): If the last enoxaparin sodium SC administration was given
less than 8 hours before balloon inflation, no additional dosing is
needed. If the last SC administration was given more than 8 hours
before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin
sodium should be administered.
Prevention of extracorporeal thrombus formation during
haemodialysis:
A dose equivalent to 1mg/kg (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.
Elderly:

(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

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).

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)

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

55

60mg/0.6ml

55 bd

0.55

60

60mg/0.6ml

60 bd

0.60

65

80mg/0.8ml

65 bd

0.65

70

80mg/0.8ml

70 bd

0.70

75

80mg/0.8ml

75 bd

0.75

40

60mg/0.6ml

30 bd

80

80mg/0.8ml

80 bd

0.80

45

60mg/0.6ml

33.75 bd

35 bd

0.35

85

100mg/1ml

85 bd

0.85

50

60mg/0.6ml

37.5 bd

37.5 bd

0.375

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

90

100mg/1ml

90 bd

0.90

100mg/ml

55

60mg/0.6ml

41.25 bd

42.5 bd

0.425

Moderate and mild renal impairment:

95

100mg/1ml

95 bd

0.95

60mg/0.6ml

45 bd

45 bd

0.45

100mg/1ml

100 bd

1.00

Solution
for

60

100

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

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.

75

60mg/0.6ml

56.25 bd

57.5 bd

0.575

syringes

80

60mg/0.6ml

60 bd

60 bd

0.60

Hepatic impairment: In the absence of clinical studies, caution
should be exercised.

85

80mg/0.8ml

63.75 bd

65 bd

0.65

Body weight:

90

80mg/0.8ml

67.5 bd

67.5 bd

0.675
0.725

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).

100mg/ml
Solution
for
Injection
Clexane
syringes

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

Kg

Syringe label

weight

Dose
(mg)

Injection
volume
(ml)

105

syringes

110 bd (1)

115

120mg/0.8ml (1)

115 bd (1)

120mg/0.8ml (1)

120 bd (1)

150mg/1ml (1)

125 bd (1)

0.84 (1)

130

150mg/1ml (1)

130 bd (1)

0.88 (1)

135

150mg/1ml (1)

135 bd (1)

0.90 (1)

140

150mg/1ml (1)

140 bd (1)

0.94 (1)

150mg/1ml (1)

145 bd (1)

0.98 (1)

150mg/1ml (1)

150 bd (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.

Syringe
label

0.75mg/kg
Dose (mg)

Adjusted
dosing
(mg)

Injection
volume
(ml)

30 bd

0.30

95

80mg/0.8ml

71.25 bd

72.5 bd

100

80mg/0.8ml

75 bd

75 bd

0.75

105

80mg/0.8ml

78.75 bd (1)

80 bd (1)

0.80 (1)

110

100mg/1ml

82.5 bd (1)

82.5 bd (1)

0.825 (1)

115

100mg/1ml

86.25 bd (1)

87.5 bd (1)

0.875 (1)

120

100mg/1ml

90 bd (1)

90 bd (1)

0.90 (1)

125

100mg/1ml

93.75 bd (1)

95 bd (1)

0.95 (1)

130

100mg/1ml

97.5 bd (1)

97.5 bd (1)

0.975 (1)

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)

150

120mg/0.8ml

112.5 bd (1)

114 bd (1)

0.76 (1)

Clexane
Forte
syringes

Standard dosing

Severe renal impairment

40 mg SC once daily

20 mg SC once daily

20 mg SC once daily

0.80 (1)

125

Kg

weight

0.78 (1)

120

Patient

0.74 (1)

150

Clexane

120mg/0.8ml (1)

Dosage adjustments for prophylactic dosage ranges

(elderly patients aged ≥75 years only)

0.70 (1)

145

Injection

105 bd (1)

110
100mg/ml
Solution
for

120mg/0.8ml (1)

Dosage chart for 0.75mg/kg SC treatment of STEMI

20 mg SC once daily

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.

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

S1630 LEAFLET Clexane 20121026 (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.

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