CLEXANE MULTIDOSE VIAL

Active substance: 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.

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
Injection
Patient weight
Kg
Dose (mg) volume
(ml) (1)
300mg/3ml
Solution for Injection
Clexane Multidose Vial

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

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight
300mg/3ml
Solution for Injection
Clexane Multidose Vial

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).

PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

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.

100mg/ml multidose vial

enoxaparin sodium

Is this leaflet hard to see or read?
Phone 01483 505515 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)
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.

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

Dose (mg)
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 bd
0.55
Multidose Vial 55
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.

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 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 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)
• 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.

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

0.75mg/kg Injection
Dose (mg) 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)

Patient weight

Kg

0.75mg/kg
Injection
Dose (mg) volume (ml) (1)

115 86.25 bd (2)
120
90 bd (2)
125 93.75 bd (2)
130
97.5 bd (2)
135 101.25 bd (2)
140
105 bd (2)
145 108.75 bd (2)
150 112.5 bd (2)

0.8625 (2)
0.90 (2)
0.9375 (2)
0.975 (2)
1.0125 (2)
1.05 (2)
1.0875 (2)
1.125 (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
30mg-single IV bolus plus 30mg-single IV bolus plus a
a 1mg/kg SC dose followed 1mg/kg SC dose followed by
by 1mg/kg twice daily.
1mg/kg once daily.
(Max 100mg for each of
(Max 100mg for first SC dose
the 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
(Max 100mg for first SC
the first two SC doses)
dose only)

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. 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.
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 after that
• 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) 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
People with kidney problems
If you have problems with your kidneys, you may be given a smaller amount of Clexane.
If you have more Clexane than you should
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.

11502569-05

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.
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.

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
• If you have had a spinal puncture or a spinal anaesthetic and notice tingling, numbness and muscular weakness,
particularly in the lower part of your body. Also if you lose control over your bladder or bowel (so you cannot
control when you go to the toilet)
Tell a nurse or doctor as soon as possible if you notice any of the following side effects:
Common (affects 1 to 10 people in a 100)
• 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
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, it may increase the risk of you getting a condition called ‘osteoporosis’.
This is when your bones are more likely to break
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: 01483 505515 - Fax: 01483 535432
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 05/2012
© sanofi, 2012
11502569-05

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

11502569-05
11502569-04
02
19.06.2012
UK
MF. Alcorcón

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
10/2011

COLOURS
P. Reflex blue

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

269
269-1
360x390
906011
10

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.

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
Injection
Patient weight
Kg
Dose (mg) volume
(ml) (1)
300mg/3ml
Solution for Injection
Clexane Multidose Vial

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

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight
300mg/3ml
Solution for Injection
Clexane Multidose Vial

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).

PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

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.

100mg/ml multidose vial

enoxaparin sodium

Is this leaflet hard to see or read?
Phone 01483 505515 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)
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.

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

Dose (mg)
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 bd
0.55
Multidose Vial 55
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.

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 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 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)
• 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.
11502569-05

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

0.75mg/kg Injection
Dose (mg) 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)

Patient weight

Kg

0.75mg/kg
Injection
Dose (mg) volume (ml) (1)

115 86.25 bd (2)
120
90 bd (2)
125 93.75 bd (2)
130
97.5 bd (2)
135 101.25 bd (2)
140
105 bd (2)
145 108.75 bd (2)
150 112.5 bd (2)

0.8625 (2)
0.90 (2)
0.9375 (2)
0.975 (2)
1.0125 (2)
1.05 (2)
1.0875 (2)
1.125 (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
30mg-single IV bolus plus 30mg-single IV bolus plus a
a 1mg/kg SC dose followed 1mg/kg SC dose followed by
by 1mg/kg twice daily.
1mg/kg once daily.
(Max 100mg for each of
(Max 100mg for first SC dose
the 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
(Max 100mg for first SC
the first two SC doses)
dose only)

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. 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.
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 after that
• 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) 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
People with kidney problems
If you have problems with your kidneys, you may be given a smaller amount of Clexane.
If you have more Clexane than you should
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.

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.
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
10/2011

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
• If you have had a spinal puncture or a spinal anaesthetic and notice tingling, numbness and muscular weakness,
particularly in the lower part of your body. Also if you lose control over your bladder or bowel (so you cannot
control when you go to the toilet)
Tell a nurse or doctor as soon as possible if you notice any of the following side effects:
Common (affects 1 to 10 people in a 100)
• 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
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, it may increase the risk of you getting a condition called ‘osteoporosis’.
This is when your bones are more likely to break
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: 01483 505515 - Fax: 01483 535432
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 05/2012
© sanofi, 2012
11502569-05

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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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