Skip to Content

UK Edition. Click here for US version.

CLEXANE 20MG SYRINGES

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Clexane® 20mg
Syringes
(enoxaparin sodium)

1. What Clexane is
and what it is used for

x

The name of your medicine is Clexane
20mg Syringes (called Clexane in this leaflet).
It is available in a pre-filled syringe. 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)

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.

Stopping b l o o d
clots
your blood.
Clexane can be used to:





In this leaflet:

in

Treat blood clots that are in your blood



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

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

o


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

o

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 40mg,
60mg, 80mg and 100mg strength.

forming



Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours

Signs of an allergic reaction include: a
rash, swallowing or breathing problems,
swelling o f your lips, face, throat or
tongue

x

Stopping existing blood clots from getting
any bigger. This helps your body to break
them down and stop them causing you
harm.

2)

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

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. Before you use Clexane

You are allergic to heparin or other Low
Molecular Weight Heparins such as
tinzaparin or dalteparin

x

You have a problem with bruising or
bleeding too easily

x

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

x

You have had a stroke caused by
bleeding in the brain

x
x

You have an infection in your heart
You are using the medicine
heparin to treat blood clots

called

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
Clexane

care

with

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

1.

What Clexane is and what it is used
for

2.

Before you use Clexane

3.

How to use Clexane

Do not have this medicine
and
tell
your
doctor, •

pharmacist or nurse if:

4.

Possible side-effects



You have had a heart valve fitted

5.

How to store Clexane



6.

Further information

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

You have high blood pressure
You have kidney problems

1 Turn over

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Clexane® 20mg, 40mg, 60mg, 80mg and 100mg Pre-Filled 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 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0 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 pre-operatively. In
patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose administered
approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a
minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and
until adequate oral anticoagulation is established.

1 Turn over

Ÿ

You have ever had a stroke

• Warfarin - used for thinning the blood

Ÿ

You have ever had a stomach ulcer

Ÿ

You have recently had an operation
on your eyes or brain

• Aspirin, d i p y r i d a m o l e , clopidogrel or
other medicines - used to stop blood
clots forming

Ÿ

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

Ÿ
Ÿ

You have any problems with your
blood

• Ibuprofen, diclofenac, ketorolac or other
medicines – used to treat pain and
swelling in arthritis and other illnesses

3. How to use Clexane
Having this medicine

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.
this

X You are using the medicine called
heparin to treat blood clots
Tell your doctor if you are taking any of
the following medicines:



• Prednisolone, dexamethasone or other
medicines – used to treat asthma,
rheumatoid arthritis and other conditions

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



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

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



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.

You are underweight or overweight

Ÿ

In particular, do not have
medicine and tell your doctor if:

• Dextran injection – used as a blood
replacer

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

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 i s usually given by injection
underneath the skin (subcutaneous)

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

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

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.
2

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Kg
Syringe label
Dose
Patient
Injection
(mg)
weight
volume (ml)
40
60mg /0.6ml
60 od
0.60
100mg/ml
45
80mg / 0.8ml
67.5 od
0.675
Solution for 50
80mg / 0.8ml
75 od
0.75
Injection
55
100mg / 1ml
82.5 od
0.825
CLEXANE
60
100mg / 1ml
90 od
0.90
syringes
65
100mg / 1ml
97.5 od
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

Kg

Syringe label

70
75
80
85
90
95
100

120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml

Dose
(mg)
105 od
112.5 od
120 od
127.5 od
135 od
142.5 od
150 od

Injection
volume (ml)
0.70
0.76
0.80
0.86
0.90
0.96
1.00

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this
table have been rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 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
Dose
Patient
Injection
Kg
Syringe label
(mg)
weight
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
45
60mg / 0.6ml
45 bd
0.45
50
60mg / 0.6ml
50 bd
0.50
55
60mg / 0.6ml
55 bd
0.55
60
60mg / 0.6ml
60 bd
0.60
100mg/ml
65
80mg / 0.8ml
65 bd
0.65
Solution for
80mg / 0.8ml
70
70 bd
0.70
Injection
80mg / 0.8ml
75
75 bd
0.75
CLEXANE
80
80mg / 0.8ml
80 bd
0.80
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 UA or NSTEMI
Dose
Injection
Patient weight
Kg
Syringe label
(mg)
volume (ml)
105
120mg / 0.8ml
105 bd
0.70
110
120mg / 0.8ml
110 bd
0.74
150mg/ml
115
120mg / 0.8ml
115 bd
0.78
Solution for
120
120mg / 0.8ml
120 bd
0.80
Injection
CLEXANE
125
150mg / 1ml
125 bd
0.84
Forte syringes
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

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.
2

1) Treating blood clots that are in your
blood

The amount of Clexane given to you will

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

depend on your age and the kind of heart
attack you have had.
i)
NSTEMI type of heart attack

• Clexane will usually be given for at least
5 days



The u s u a l
amount is 1mg for
every kilogram of weight, every 12 hours

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



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

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

ii)

STEMI type of heart attack

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



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

a) Unstable angina

b) After an operation or long periods of
bedrest due to illness

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.

• 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



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



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

• 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



The injections will normally be given for
up to 8 days

The usual dose is 20mg or 40mg each day.
The dose will depend on how likely you are
to develop a clot

• If you are bedridden due to illness, you
will be normally be given 40mg of Clexane
each day for 6 to 14 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 u s u a l
dose is 0.75mg for
every kilogram of your weight, every 12
hours

c) After you have had a heart attack
Clexane can be used for two different types
of heart attack called NSTEMI or STEMI.



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



Depending on when you were last given
Clexane, your doctor may decide to give
an additional dose of Clexane before a
PCI operation. This is by injection into
your vein (intravenous using Clexane
Multidose Vial or 60, 80 or 100mg Prefilled syringes)

3.

Stop blood clots forming in the tubes
of your dialysis machine



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



Clexane is added to the tube leaving the
body (arterial line) at the start of the
dialysis session



This amount is usually enough for a 4
hour session. However, your doctor may
give you a further dose of 0.5 to 1mg for
every kilogram of your weight if
necessary

How to give yourself an injection of
Clexane
If you are able to give Clexane to yourself,
your doctor or nurse will show you how to do
this. Do not try to inject yourself if you have not
been trained how to do so. If you are not sure
what to do, talk to your doctor or nurse
immediately.
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

3 Turn over

Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for
the first two doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2 Posology and method of
administration: Elderly.
Dosage chart for 1mg/kg SC treatment of STEMI
Dosage chart for 1mg/kg SC treatment of STEMI
Kg
Syringe label
Dose
Patient
Injection
Patient weight
Kg
Syringe label
Dose (mg)
Injection
(mg)
weight
volume (ml)
volume (ml)
40
40mg / 0.4ml
40 bd
0.40
105
120mg / 0.8ml (1)
105 bd (1)
0.70 (1)
45
60mg / 0.6ml
45 bd
0.45
110
120mg / 0.8ml (1)
110 bd (1)
0.74 (1)
50
60mg / 0.6ml
50 bd
0.50
115
120mg / 0.8ml (1)
115 bd (1)
0.78 (1)
100mg/ml
55
60mg / 0.6ml
55 bd
0.55
120
120mg / 0.8ml (1)
120 bd (1)
0.80 (1)
100mg/ml
Solution for 60
60mg / 0.6ml
60 bd
0.60
Solution for
125
150mg / 1ml (1)
125 bd (1)
0.84 (1)
Injection
65
80mg / 0.8ml
65 bd
0.65
Injection
130
150mg / 1ml (1)
130 bd (1)
0.88 (1)
CLEXANE
70
80mg / 0.8ml
70 bd
0.70
CLEXANE
135
150mg / 1ml (1)
135 bd (1)
0.90 (1)
syringes
75
80mg / 0.8ml
75 bd
0.75
syringes
140
150mg / 1ml (1)
140 bd (1)
0.94 (1)
80
80mg / 0.8ml
80 bd
0.80
145
150mg / 1ml (1)
145 bd (1)
0.98 (1)
85
100mg / 1ml
85 bd
0.85
150
150mg / 1ml (1)
150 bd (1)
1.00 (1)
90
100mg / 1ml
90 bd
0.90
95
100mg / 1ml
95 bd
0.95
100
100mg / 1ml
100 bd
1.00
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this
table have been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodium should be given between 15 minutes before and 30
minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained
under (75 to 325mg once daily) unless contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon
inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin
sodium should be administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 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).
3 Turn over



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, b u t not too near the belly
button or any scar tissue (at least 5 cm
away from these)

3) Choose an area on the right or left side of
your stomach. This should be at least 5
centimetres away from your belly button
and out towards your sides.
Remember: Do not inject yourself within 5
centimetres of your belly button or around
existing scars or bruises. Change the place
where you inject between the left and right
sides of your stomach, depending on the
area you were last injected.
4)

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

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.

Instructions on injecting yourself with
Clexane:

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.

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.

Make sure you hold the skin fold throughout
the injection.

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 a n y t h i n g . This i s 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

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.

.
4

Patient weight

100mg/ml
Solution for Injection
CLEXANE syringes

150mg/ml
Solution for Injection
CLEXANE Forte
syringes

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)
40
60mg / 0.6ml
30 bd
30 bd
0.30
45
60mg / 0.6ml
33.75 bd
35 bd
0.35
50
60mg / 0.6ml
37.5 bd
37.5 bd
0.375
55
60mg / 0.6ml
41.25 bd
42.5 bd
0.425
60
60mg / 0.6ml
45 bd
45 bd
0.45
65
60mg / 0.6ml
48.75 bd
50 bd
0.5
70
60mg / 0.6ml
52.5 bd
52.5 bd
0.525
75
60mg / 0.6ml
56.25 bd
57.5 bd
0.575
80
60mg / 0.6ml
60 bd
60 bd
0.60
85
90
95
100
105
110
115
120
125
130
135
140
145
150

80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml

63.75 bd
67.5 bd
71.25 bd
75 bd
78.75 bd (1)
82.5 bd (1)
86.25 bd (1)
90 bd (1)
93.75 bd (1)
97.5 bd (1)
101.25 bd (1)
105 bd (1)
108.75 bd (1)
112.5 bd (1)

65 bd
67.5 bd
72.5 bd
75 bd
80 bd (1)
82.5 bd (1)
87.5 bd (1)
90 bd (1)
95 bd (1)
97.5 bd (1)
102 bd (1)
105 bd (1)
111 bd (1)
114 bd (1)

0.65
0.675
0.725
0.75
0.80 (1)
0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)
0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1)

(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended
in this table have been rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal impairment and Monitoring; section 5.2 Pharmacokinetic
properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min), according to the following tables, since
enoxaparin sodium exposure is significantly increased in this patient population:
4

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.
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.
If you have more Clexane than you
should

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

4. Possible side-effects
Like all medicines, Clexane can cause sideeffects, although not everybody gets them.
Tell a nurse or doctor or go to h os pi t al
straight away if you notice any of the
following side-effects:
Very c o m m o n (affects more than 1 in 10
people)


Bleeding a lot from a wound.

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 sideeffects:
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.

Common (affects 1 to 10 people in a 100)

• A painful rash of dark red spots under the
If you think that you have used too much or
skin which do not go away when you put
too little Clexane, tell your doctor, nurse or
pressure on them. You may also notice
pharmacist immediately, even if you have
pink patches on your skin. These are more
no signs of a problem. If a child
likely to appear in the area you have been
accidentally injects or swallows Clexane,
injected with Clexane.
take them to a hospital casualty
Uncommon (affects 1 to 10 people in a
department straight away.
1,000)
If you forget to use Clexane
• Sudden severe headache. This could be a
If you forget to give yourself a dose, have it
sign of bleeding in the brain.
as soon as you remember. Do not give
• A feeling of tenderness and swelling in your
yourself a double dose on the same day to
stomach. You may have bleeding inside
make up for a forgotten dose. Keeping a
your stomach.
diary will help to make sure you do not
Rare (affects less than 1 in a 1000 people)
miss a dose.
If you stop using Clexane



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



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

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.

Other side effects that you should discuss
with your nurse or doctor i f
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.

If you have had a spinal puncture or a

5 Turn over

Dosage adjustments for therapeutic dosage range
Standard
dosing
1 mg/kg SC twice
daily
1.5 mg/kg SC once
daily

Severe renal
impairment
1 mg/kg SC once
daily
1 mg/kg SC once
daily
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg twice daily. 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)
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.
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 STEMIindication 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.
5 Turn over

Rare (affects less than 1 in a 1000 people)

6. Further Information

Product Licence Holder



What Clexane contains

Each 20mg pre-filled syringe contains
20mg (2,000 IU anti-Xa activity) of the
active substance, enoxaparin sodium in
0.2ml

Clexane is procured from within the EU and is
repackaged for the Product Licence holder
Export Credit Corporation, 302 Regent Street,
London W1R 6HH, United Kingdom.

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, it can increase the risk of you
getting
a
condition
called
‘osteoporosis’. This is when your
bones are more likely to break

5. How to store and dispose of
Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date
which is stated on the carton. The expiry
date refers to the last day of that month.
If the medicine shows any signs of
discolouration or if the syringe appears
faulty, you should seek the advice of your
pharmacist who will tell you what to do.



The other ingredient is water for injections

What Clexane Pre-filled Syringes looks
like and contents of the pack
Clexane is supplied in packs of 10 syringes.
Clexane is a clear solution in a Type I glass
prefilled syringe fitted with an injection needle
and needle cap.
The pre-filled syringe is of a “safety-lock”
system and comes within a sealed pouch.
Clexane is supplied in packs of 10 syringes.

PL 20262/0001

POM

Manufacturer
Sanofi Winthrop Industrie, 82 Avenue Raspail,
F-94250 Gentily, France.
Chinoin Pharmaceutical and Chemical Works
Private Company Limited, 3510 Miskolc,
Csanyikvolgy, Hungary.
This leaflet does not contain all the information
about your medicine. If you have any
questions or are not sure about anything, ask
your doctor or pharmacist.
This leaflet was last revised in 30/08/12.
Clexane® is a registered trademark of Sanofi Aventis
SA

Do not store above 25° Do not store in a
C.
refrigerator or freezer.
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, nurse or
pharmacist for disposal. These measures
will help to protect the environment.

6

• 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
Volume to inject when diluted to a
(Kg)
(0.3 mg/kg) (mg)
final concentration of 3 mg/ml (ml)
45
13.5
4.5
50
15
5
55
16.5
5.5
60
18
6
65
19.5
6.5
70
21
7
75
22.5
7.5
80
24
8
85
25.5
8.5
90
27
9
95
28.5
9.5
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% dextrose in water.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers - discard any unused product.

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

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

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

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 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
7.

8.

PL(PI) HOLDER
Procured from within the EU and repackaged by the Parallel Import
Product Licence holder Export Credit Corporation Limited, Suite 401,
302 Regent Street, London W1R 6HH, UK..
PL 20262/0001 Clexane® 20mg Syringes
DATE OF REVISION OF THE TEXT
30/08/12
® Registered trademark of Sanofi Aventis SA.

6

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide