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CLEXANE MULTIDOSE VIAL

Active substance(s): ENOXAPARIN SODIUM

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THE FOLLOWING INFORMATION IS INTENDED FOR
HEALTHCARE PROFESSIONALS ONLY
®

100mg/ml multidose vial

enoxaparin sodium Ph. Eur
Clexane 100mg/ml multidose vial
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® Multidose Vial
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vials containing 300 mg enoxaparin (equivalent to 30,000 IU
anti-Xa activity) in 3.0 ml
Contains benzyl alcohol (45mg in 3.0 ml)
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sterile pyrogen-free solution for injection contained in a
multidose vial for single patient use.
Clear, colourless to slightly 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.
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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

®

100mg/ml multidose vial

enoxaparin sodium

Is this leaflet hard to see or read?
Phone 0845 372 7101 for help
Read all of this leaflet carefully before you start using
this medicine
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or
pharmacist
• This medicine has been prescribed for you. Do not pass
it on to others It may harm them, even if their
symptoms are the same as yours
• If any of the side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist
In this leaflet:
1. What Clexane is and what it is used for
2. Before you have Clexane
3. How Clexane is given
4. Possible side-effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is used for
The name of your medicine is Clexane 100mg/ml Multidose
Vial (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
2) Stopping blood clots forming in your blood
Clexane can be used to:
• Treat blood clots that are in your blood
• Stop blood clots forming in your blood in the following
situations:
• Unstable angina (where not enough blood gets to
your heart)
• After an operation or long periods of bed rest due to
illness
• After you have had a heart attack
• Stop blood clots forming in the tubes of your dialysis
machine (used for people with kidney problems)

Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU)
once daily by subcutaneous injection. Treatment with enoxaparin
sodium is prescribed for a minimum of 6 days and continued
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily
injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually
prescribed for at least 5 days and until adequate oral
anticoagulation is established.
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or
both
Patient weight
300mg/3ml
Solution for Injection
Clexane Multidose Vial

Kg

Dose (mg)

Injection
volume
(ml) (1)

40
45
50
55
60
65
70
75
80
85
90
95
100

60 od
67.5 od
75 od
82.5 od
90 od
97.5 od
105 od
112.5 od
120 od
127.5 od
135 od
142.5 od
150 od

0.60
0.675
0.75
0.825
0.90
0.975
1.05
1.125
1.20
1.275
1.35
1.425
1.50

(1) the injection volumes are those needed to achieve the
required dose. However, rounding up dose adjustments may
need to be taken into consideration depending on the
graduations of the syringe used.
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 325 mg once daily).

Treatment with Clexane in these patients should be prescribed
for a minimum of 2 days and continued until clinical stabilisation.
The usual duration of treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight
300mg/3ml
Solution for Injection
Clexane Multidose Vial

Kg

Dose (mg)

40
45
50
55
60
65
70
75
80
85
90
95
100
105
110
115
120
125
130
135
140
145
150

40 bd
45 bd
50 bd
55 bd
60 bd
65 bd
70 bd
75 bd
80 bd
85 bd
90 bd
95 bd
100 bd
105 bd
110 bd
115 bd
120 bd
125 bd
130 bd
135 bd
140 bd
145 bd
150 bd

Injection
volume
(ml)
0.40
0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00
1.05
1.10
1.15
1.20
1.25
1.30
1.35
1.40
1.45
1.50

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
Dose (mg) Injection volume (ml)
40
40 bd
0.40
300mg/3ml
45
45 bd
0.45
Solution for
50 bd
0.50
Injection Clexane 50
55
55 bd
0.55
Multidose Vial
60
60 bd
0.60
65
65 bd
0.65
70
70 bd
0.70
75
75 bd
0.75
80
80 bd
0.80
85
85 bd
0.85
90
90 bd
0.90
95
95 bd
0.95
100
100 bd
1.00
105 (1) 105 bd (1)
1.05 (1)
110 (1) 110 bd (1)
1.10 (1)
115 (1) 115 bd (1)
1.15 (1)
120 (1) 120 bd (1)
1.20 (1)
125 (1) 125 bd (1)
1.25 (1)
130 (1) 130 bd (1)
1.30 (1)
135 (1) 135 bd (1)
1.35 (1)
140 (1) 140 bd (1)
1.40 (1)
145 (1) 145 bd (1)
1.45 (1)
150 (1) 150 bd (1)
1.50 (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)
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.

11502569-08

2. Before you have 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)
- heparin or other Low Molecular Weight Heparins
such as tinzaparin or dalteparin
Signs of an allergic reaction include: a rash, swallowing
or breathing problems, swelling of your lips, face,
throat or tongue
 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 heparin to treat blood clots (see “Taking
other medicines”)
 The patient is under 3 years old
Do not take this medicine if any of the above apply to you.
If you are not sure, talk to your doctor, pharmacist or
nurse before having Clexane.
Take special care with Clexane
Check with your doctor or pharmacist or nurse before
having this medicine if:
 You have high blood pressure
 You have kidney problems (see “People with kidney
problems” in Section 3 - page 2)
 You have had a heart valve fitted
 You have ever had bruising and bleeding caused by the
medicine ‘heparin’
 You have ever had a stroke
 You have ever had a stomach ulcer
 You have recently had an operation on your eyes or
brain
 You are a diabetic or have an illness known as ‘diabetic
retinopathy’ (problems with the blood vessels in the eye
caused by diabetes)
 You have any problems with your blood
 You are underweight or overweight
 You are elderly (over 65 years old) and especially if you
are aged over 75 years old
If you are not sure if any of the above applies to you, talk
to your doctor, or pharmacist or nurse before having
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.
Do not take and tell your doctor if you are taking
the following medicine:
• Heparin - used to treat blood clots
Tell your doctor if you are taking any of the
following medicines:
• Warfarin – used for thinning the blood
• Aspirin, dipyridamole, clopidogrel or other medicines
- used to stop blood clots forming
• Dextran injection - used to replace blood volume
• Ibuprofen, diclofenac, ketorolac or other medicines used to treat pain and swelling in arthritis and other
illnesses
• Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other
conditions
• Water tablets (diuretics) such as spironolactone,
triamterene or amiloride. These may increase the
levels of potassium in your blood when taken with
Clexane
Your doctor may change one of your medicines or take
regular blood tests to check that taking these medicines
with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an operation
where an epidural or spinal anaesthetic is used, tell your
doctor that you are having 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 are given 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.

Important information about some of the ingredients
of Clexane
Clexane Multidose Vial contains benzyl alcohol. It must
not be given to premature or newborn babies. Benzyl
alcohol may cause toxic reactions and allergic reactions in
infants and children up to 3 years old.
3. How Clexane is given
Having this medicine
• Your doctor or nurse will normally give you Clexane.
This is because it needs to be given as an injection
• Clexane is usually given by injection underneath the
skin (subcutaneous)
• Do not inject Clexane into a muscle (intramuscular)
• Clexane can be given by injection into your vein
(intravenous) after certain types of heart attack or
operation
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
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 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
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 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
11502569-08

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 1 mg/kg
(50 to 100 IU/kg) may be given. For patients at a high risk of
haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg)
for double vascular access or 0.75 mg/kg (75 IU/kg) for single
vascular access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial
Infarction in elderly patients ≥75 years of age, do not use an
initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours
(maximum 75mg for the first two doses only, followed by
0.75mg/kg dosing for the remaining doses).
For other indications, no dosage adjustments are necessary in
the elderly, unless kidney function is impaired (see also section
4.2 Posology and method of administration: Renal impairment;
section 4.4 Special warnings and precautions for use:
Haemorrhage in the elderly; Renal impairment and Monitoring;
section 5.2 Pharmacokinetic properties).
Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged ≥75 years only)
Patient weight

Kg

300mg/3ml
Solution for Injection
Clexane Multidose Vial

40
45
50
55
60
65
70
75
80
85
90
95
100
105
110

Injection
volume
(ml) (1)
30 bd
0.30
33.75 bd
0.3375
37.5 bd
0.375
41.25 bd
0.4125
45 bd
0.45
48.75 bd
0.4875
52.5 bd
0.525
56.25 bd
0.5625
60 bd
0.60
63.75 bd
0.6375
67.5 bd
0.675
71.25 bd
0.7125
75 bd
0.75
78.75 bd (2) 0.7875 (2)
82.5 bd (2) 0.825 (2)

0.75mg/kg
Dose (mg)

c) After you have had a heart attack
Clexane can be used for two different types of
heart attack called NSTEMI or STEMI. The amount
of Clexane given to you will depend on your age
and the kind of heart attack you have had.
i) NSTEMI type of heart attack
• The usual amount is 1mg for every kilogram
of weight, every 12 hours
• Clexane will usually be given for 2 to 8 days.
Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
• 30mg of Clexane will be given as an injection
into your vein (intravenous injection)
• At the same time, you will also be given
Clexane as an injection under your skin
(subcutaneous injection). The usual dose is
1mg for every kilogram of your weight.
• Then you will be given 1mg for every kilogram
of your weight every 12 hours
• The maximum amount of Clexane given for
the first two injections is 100mg
• The injections will normally be given for up
to 8 days
If you are aged 75 years or older
• Your doctor or nurse will give you injections
of Clexane under your skin (subcutaneous
injection)
• The usual dose is 0.75mg for every kilogram
of your weight, every 12 hours
• The maximum amount of Clexane given for
the first two injections is 75mg
For patients having an operation called
Percutaneous Coronary Intervention (PCI)
• Depending on when you were last given
Clexane, your doctor may decide to give an
additional dose of Clexane before a PCI
operation. This is by injection into your vein
(intravenous)
3) Stopping 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

0.75mg/kg
Injection
Dose (mg)
volume (ml) (1)
115
0.8625 (2)
86.25 bd (2)
120
0.90 (2)
90 bd (2)
125
0.9375 (2)
93.75 bd (2)
130
0.975 (2)
97.5 bd (2)
135
1.0125 (2)
101.25 bd (2)
140
1.05 (2)
105 bd (2)
145
1.0875 (2)
108.75 bd (2)
150
1.125 (2)
112.5 bd (2)
(1) the injection volumes are those needed to achieve the
required dose. However, rounding up dose adjustments may
need to be taken into consideration depending on the
graduations of the syringe used.
(2) 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)
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 ranges
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
Patient weight

Kg

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

People with kidney problems
If you have problems with your kidneys, you may be given
a smaller amount of Clexane.
If you have too much or too little Clexane
Your doctor will carefully calculate how much Clexane you
should get. Therefore it is unlikely your doctor, nurse or
pharmacist will give you too much of this medicine. But, if
you think that you have been given too much or too little
Clexane, tell your doctor, nurse or pharmacist.
If you stop using Clexane
It is important for you to keep having Clexane injections
until your doctor decides to stop them. If you stop, you
could get a blood clot which can be very dangerous.
Blood Tests
Using Clexane may affect the results of some blood tests.
If you are going to have a blood test, it is important to tell
your doctor you are having Clexane.
4. Possible side-effects
Like all medicines, Clexane can cause side-effects,
although not everybody gets them.
Tell a nurse or doctor straight away if you
notice any of the following side-effects:
Very common (affects more than 1 in 10 people)
• Bleeding a lot from a wound
Common (affects 1 to 10 people in a 100)
• A painful rash of dark red spots under the skin which do
not go away when you put pressure on them. You may also
notice pink patches on your skin. These are more likely to
appear in the area you have been injected with Clexane
Uncommon (affects 1 to 10 people in a 1,000)
• Sudden severe headache. This could be a sign of
bleeding in the brain
• A feeling of tenderness and swelling in your stomach.
You may have bleeding inside your stomach
Rare (affects less than 1 in a 1000 people)
• If you have an allergic reaction. The signs may include:
a rash, swallowing or breathing problems, swelling of
your lips, face, throat or tongue
Frequency unknown
• If you have had a spinal puncture or a spinal
anaesthetic and notice tingling, numbness and
muscular weakness, particularly in the lower part of
your body. Also if you lose control over your bladder or
bowel (so you cannot control when you go to the toilet)

Dosage adjustments for prophylactic dosage ranges
Standard dosing
Severe renal impairment
40 mg once daily
20 mg once daily
20 mg once daily
20 mg once daily
The recommended dosage adjustments do not apply to the
haemodialysis indication.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients
with moderate renal impairment (creatinine clearance
30-50 ml/min) or mild renal impairment (creatinine clearance
50-80 ml/min), careful clinical monitoring is advised.
Spinal/epidural anaesthesia:
For patients receiving spinal/epidural anaesthesia see section
4.4 Special warnings and precautions for use: Spinal/epidural
anaesthesia.
Hepatic impairment: In the absence of clinical studies, caution
should be exercised.
Body weight: No dosage adjustments are recommended in
obesity or low body weight (see also section 4.4 Special warnings
and precautions for use: Low body weight and Monitoring;
section 5.2 Pharmacokinetic properties).
Clexane is administered by subcutaneous injection for the
prevention of venous thromboembolic disease, the treatment of
deep vein thrombosis or for the treatment of unstable angina,
non-Q-wave myocardial infarction and acute ST elevation
myocardial infarction (STEMI); through the arterial line of a
dialysis circuit for the prevention of thrombus formation in the
extra-corporeal circulation during haemodialysis; and via
intravenous (bolus) injection through an intravenous line only for
the initial dose of acute STEMI indication and before PCI when
needed. It must not be administered by the intramuscular route.
Subcutaneous Injection Technique
When using vials of enoxaparin sodium, the volume to be
injected should be measured precisely with a graduated syringe
fitted with an appropriate needle for subcutaneous injection.
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. 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 the drug. Enoxaparin
sodium may be safely administered with normal saline solution
(0.9%) or 5% dextrose in water.
6
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl alcohol (45mg/3ml)
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
2 years
6.4 Special precautions for storage
Store below 25°C.
The contents of the multidose vial should be used within
28 days of opening.
6.5 Nature and contents of container
Boxes containing a single 3 ml multidose glass vial for
single patient use.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 18 August 1997
Date of latest renewal: 06 September 2002
10 DATE OF REVISION OF THE TEXT
06/2015
11502569-08

Tell a nurse or doctor as soon as possible if you notice
any of the following side effects:
Common (affects 1 to 10 people in a 100)
• You bruise more easily than usual. This could be
because of a blood problem (thrombocytopenia)
• You have pain, swelling or irritation in the area you
have been injected with Clexane. This normally gets
better after a few days
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
Frequency unknown
• Feeling tired, faint, dizzy, having pale skin. These could
be symptoms of anaemia.
• You notice yellowing or your skin or eyes and your urine
becomes darker in colour. This could be a liver problem.
Other side effects that you should discuss with your
doctor if you are concerned about them:
Very common (affects more than 1 in 10 people)
• Changes in the results of blood tests done to check how
your liver is working. These usually go back to normal
after you stop having Clexane
Rare (affects less than 1 in a 1000 people)
• Changes in the potassium levels in your blood. This is
more likely to happen in people with kidney problems
or diabetes. Your doctor will be able to check this by
carrying out a blood test
Frequency unknown
• If Clexane is used for a long period of time (more than
3 months), it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones
are more likely to break
• Headache
• Hair loss
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet.

5. How to store Clexane
Keep this medicine in a safe place where children cannot
see or reach it.
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.
Store below 25°C. The contents of the vial should not be
used for more than 28 days after opening.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. Further Information
What Clexane contains
• Each multidose vial contains 300mg (30 000 IU) of the
active substance, enoxaparin sodium in 3ml
• The other ingredients are benzyl alcohol (45mg/3ml)
and water for injections
What Clexane looks like and contents of the pack
Clexane Multidose Vial contains a clear, colourless to
slightly yellow solution, it is available as single glass vials
only.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62, Alcorcón 28923 (Madrid) Spain
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 06/2015
© Sanofi, 1997 - 2015

United Kingdom
You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
Malta
You can also report side effects directly via ADR Reporting
www.medicinesauthority.gov.mt/adrportal
By reporting side effects you can help provide more
information on the safety of this medicine.
11502569-08

Artworks Department. Madrid. Spain
Product Description: Clexane MDV
SAP-/ID number:
Replace:
Version number:
Date:
Country:
Designer:

11502569-08
11502569-07
02
02.06.2015
UK
MLP

COLOURS
P. Reflex blue

Technical plans St:
Zt:
Dimensions:
Laetus number:
Folder nº:
Minimum point size:

269
269-1
360x390
1397200
10

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Source: Medicines and Healthcare Products Regulatory Agency

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

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