PACKAGE LEAFLET: Clexane can be used to: Take special care with Clexane

INFORMATION FOR THE USER Treat blood clots that are in your blood Check with your doctor or pharmacist or
® Stop blood clots forming in your blood in the nurse before using this medicine if:
Clexane 60mg/0.6ml Syringes following situations:
(enoxaparin sodium) Unstable angina (where not enough  You have high blood pressure
blood gets to your heart)  You have kidney problems
Read all of this leaflet carefully before you  You have had a heart valve fitted
start using this medicine After an operation or long periods of
bed rest due to illness  You have ever had bruising and bleeding
Keep this leaflet. You may need to read it caused by the medicine ‘heparin’
again After you have had a heart attack
 You have ever had a stroke
If you have any further questions, ask your Stop blood clots forming in the tubes of your
 You have ever had a stomach ulcer
doctor or pharmacist dialysis machine (used for people with
 You have recently had an operation on your
This medicine has been prescribed for you. kidney problems)
eyes or brain
Do not pass it on to others. It may harm  You are a diabetic or have an illness known
them, even if their symptoms are the same 2. Before you use Clexane
as ‘diabetic retinopathy’ (problems with the
as yours Do not have this medicine and tell your blood vessels in the eye caused by
If any of the side effects get serious, or if doctor, pharmacist or nurse if: diabetes)
you notice any side effects not listed in this
You are allergic (hypersensitive) to  You have any problems with your blood
leaflet, please tell your doctor or pharmacist
enoxaparin sodium or any of the other  You are underweight or overweight
Please note that the leaflet also contains ingredients of Clexane (listed in Section 6:  You are elderly (over 65 years old) and
information about other strengths, Clexane ‘Further information’) especially if you are aged over 75 years old
20mg, 40mg, 80mg and 100mg Syringes. Signs of an allergic reaction include: a rash, If you are not sure if any of the above applies to
In this leaflet: swallowing or breathing problems, swelling of you, talk to your doctor or pharmacist or nurse
1. What Clexane is and what it is used for your lips, face, throat or tongue before using Clexane.
2. Before you use Clexane You are allergic to heparin or other Low Taking or using other medicines
3. How to use Clexane Molecular Weight Heparins such as
Please tell your doctor, pharmacist or nurse if
4. Possible side effects tinzaparin or dalteparin
you are taking or have recently taken any other
5. How to store Clexane You have a problem with bruising or medicines. This includes medicines you buy
6. Further information bleeding too easily without a prescription, including herbal
You have an ulcer in your stomach or gut medicines. This is because Clexane can affect
1. What Clexane is and what it is (intestine) the way some other medicines work. Also some
used for You have had a stroke caused by bleeding medicines can affect the way Clexane works.
in the brain In particular, do not have this medicine
The name of your medicine is Clexane
You have an infection in your heart and tell your doctor if:
60mg/0.6ml Syringes but it will be referred as
You are using the medicine called heparin to You are using the medicine called
Clexane throughout this leaflet. Clexane
treat blood clots heparin to treat blood clots
contains a medicine called enoxaparin sodium.
This belongs to a group of medicines called Do not have this medicine if any of the above Tell your doctor if you are taking any of
Low Molecular Weight Heparins. apply to you. If you are not sure, talk to your the following medicines:
doctor, pharmacist or nurse before having Warfarin - used for thinning the blood
Clexane works in two ways.
Clexane. Aspirin, dipyridamole, clopidogrel or other
1) Stopping existing blood clots from getting
medicines – used to stop blood clots
any bigger. This helps your body to break
forming
them down and stop them causing you
harm.
2) Stopping blood clots forming in your blood.


1
7 THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
1 Clexane® 60mg0.6/ml Syringes
(enoxaparin sodium) Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
5 The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes Patient Injection
Kg Syringe label Dose (mg)
6 weight volume (ml)

6 1 NAME OF THE MEDICINAL PRODUCT

70 120mg / 0.8ml 105 od 0.70
Clexane® 60mg/0.6ml Syringes
0 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 150mg/ml 75 120mg / 0.8ml 112.5 od 0.76
Pre-filled syringes: Solution for
4 Injection 80 120mg / 0.8ml 120 od 0.80
60mg Injection Enoxaparin sodium 60mg (equivalent to 6,000IU anti-Xa activity) in 0.6ml Water for
Injections CLEXANE 85 150mg / 1ml 127.5 od 0.86
Forte
For full list of excipients, see section 6.1 syringes 90 150mg / 1ml 135 od 0.90
3 PHARMACEUTICAL FORM
Solution for injection. 95 150mg / 1ml 142.5 od 0.96
Clear, colourless to pale yellow solution. 100 150mg/ 1ml 150 od 1.00
4.2 Posology and method of administration
Adults: Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
Prophylaxis of venous thromboembolism: on the syringe and so some of the volumes recommended in this table have been rounded up to the
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is nearest graduation.
20mg (2,000IU) 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 Treatment of unstable angina and non-Q-wave myocardial infarction
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery, The recommended dose is 1mg/kg Clexane every 12 hours by subcutaneous injection, administered
the dosage should be 40mg (4,000IU) daily by subcutaneous injection with the initial dose concurrently with oral aspirin (100 to 325mg once daily). Treatment with Clexane in these patients
administered approximately 12 hours before surgery. should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual
In patients with a high-risk of venous thromboembolism who undergo abdominal or pelvic surgery for duration of treatment is 2 to 8 days.
cancer and are not otherwise at risk for major bleeding complications, the recommended dosage is
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery. Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued Patient Injection
Kg Syringe label Dose (mg)
weight volume (ml)
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 1.5mg/kg (150IU/kg). 40 40mg / 0.4ml 40 bd 0.40
Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is
established. 45 60mg / 0.6ml 45 bd 0.45

50 60mg / 0.6ml 50 bd 0.50

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
55 60mg / 0.6ml 55 bd 0.55
Patient Injection
Kg Syringe label Dose (mg) 60 60mg / 0.6ml 60 bd 0.60
weight volume (ml)
100mg/ml 65 80mg / 0.8ml 65 bd 0.65
40 60mg / 0.6ml 60 od 0.60 Solution for
Injection 70 80mg / 0.8ml 70 bd 0.70
45 80mg / 0.8ml 67.5 od 0.675 CLEXANE
100mg/ml syringes 75 80mg / 0.8ml 75 bd 0.75
Solution for 50 80mg / 0.8ml 75 od 0.75
Injection 80 80mg / 0.8ml 80 bd 0.80
CLEXANE 55 100mg / 1ml 82.5 od 0.825
syringes 85 100mg / 1ml 85 bd 0.85
60 100mg / 1ml 90 od 0.90
90 100mg / 1ml 90 bd 0.90
65 100mg / 1ml 97.5 od 0.975
95 100mg / 1ml 95 bd 0.95

100 100mg / 1ml 100 bd 1.00

 Dextran injection - used as a blood replacer When you go home you may need to If you are bedridden due to illness, you will
Ibuprofen, diclofenac, ketorolac or other continue to use Clexane and give it to be normally be given 40mg of Clexane each
medicines – used to treat pain and swelling yourself (see below instructions on how to day for 6 to 14 days
in arthritis and other illnesses do this) c) After you have had a heart attack
Prednisolone, dexamethasone or other Clexane is usually given by injection Clexane can be used for two different types of
medicines – used to treat asthma, underneath the skin (subcutaneous) heart attack called NSTEMI or STEMI.
rheumatoid arthritis and other conditions Do not inject Clexane into a muscle The amount of Clexane given to you will
Water tablets (diuretics) such as (intramuscular) depend on your age and the kind of heart attack
spironolactone, triamterene or amiloride. If you are not sure why you are receiving you have had.
These may increase the levels of potassium Clexane or have any questions about how i) NSTEMI type of heart attack
in your blood when taken with Clexane much Clexane is being given to you, speak to The usual amount is 1mg for every kilogram
Your doctor may change one of your medicines your doctor, pharmacist or nurse. of weight, every 12 hours
or take regular blood tests to check that taking How much will be given to you Clexane will usually be given for 2 to 8 days.
these medicines with Clexane is not causing Your doctor will decide how much to give Your doctor will normally ask you to take
you any harm. you. The amount of Clexane given to you aspirin as well
Operations and anaesthetics will depend on the reason it is being used ii) STEMI type of heart attack
If you are going to have a spinal puncture or an If you have problems with your kidneys, you If you are under 75 years old
operation where an epidural or spinal may be given a smaller amount of Clexane 30mg of Clexane will be given as an
anaesthetic is used, tell your doctor that you are injection into your vein (intravenous injection
1) Treating blood clots that are in your blood
using Clexane. Tell also your doctor if you have using Clexane Multidose Vial or 60, 80 or
The usual dose is 1.5mg for every kilogram
any problem with your spine or if you have ever 100mg Pre-filled syringes)
of your weight, each day
had spinal surgery. At the same time, you will also be given
Clexane will usually be given for at least 5
Pregnancy and breast-feeding days Clexane as an injection under your skin
Talk to your doctor before you use this medicine 2) Stopping blood clots forming in your (subcutaneous injection). The usual dose is
if you are pregnant, might become pregnant, or blood in the following situations: 1mg for every kilogram of your weight.
think you may be pregnant. a) Unstable angina Then you will be given 1mg for every kilogram of
You should not use this medicine if you are pregnant The usual amount is 1mg for every kilogram your weight every 12 hours
and have a mechanical heart valve as you may be at of weight, every 12 hours The maximum amount of Clexane given for
increased risk of developing blood clots. Your doctor Clexane will usually be given for 2 to 8 days. the first two injections is 100mg
should discuss this with you. Your doctor will normally ask you to take The injections will normally be given for up
aspirin as well to 8 days
You should not breast-feed whilst using If you are aged 75 years or older
Clexane. If you are planning to breast-feed, talk b) After an operation or long periods of
bedrest due to illness Your doctor or nurse will give you injections
to your doctor, pharmacist or nurse.
The usual dose is 20mg or 40mg each day. of Clexane under your skin (subcutaneous
Ask your doctor or pharmacist for advice before injection)
The dose will depend on how likely you are
taking any medicine if you are pregnant or The usual dose is 0.75mg for every kilogram
to develop a clot
breast-feeding. of your weight, every 12 hours
If you have a low to medium risk of getting a
clot, you will be given 20mg of Clexane each The maximum amount of Clexane given for
3. How to use Clexane the first two injections is 75mg
day for 7 to 10 days. If you are going to have
Having this medicine an operation, your first injection will usually For patients having an operation called
Before you use Clexane your doctor or be given 2 hours before your operation Percutaneous Coronary Intervention (PCI)
nurse may carry out a blood test If you have a higher risk of getting a clot, Depending on when you were last given
While you are in hospital your doctor or you will be given 40mg each day for 7 to 28 Clexane, your doctor may decide to give an
nurse will normally give you Clexane. This is days. If you are going to have an operation, additional dose of Clexane before a PCI
because it needs to be given as an injection your first injection will usually be given 12 operation. This is by injection into your vein
hours before your operation (intravenous using Clexane Multidose Vial or
60, 80 or 100mg Pre-filled syringes)


1
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI Dosage chart for 1mg/kg SC treatment of STEMI
7
Patient Injection
1 weight
Kg Syringe label Dose (mg)
volume (ml)
Patient
Kg Syringe label Dose (mg)
Injection
weight volume (ml)
5
105 120mg / 0.8ml 105 bd 0.70
6 105 120mg / 0.8ml (1) 105 bd (1) 0.70 (1)
110 120mg / 0.8ml 110 bd 0.74
6 110 120mg / 0.8ml (1) 110 bd (1) 0.74 (1)
115 120mg / 0.8ml 115 bd 0.78
0 150mg/ml 115 120mg / 0.8ml (1) 115 bd (1) 0.78 (1)
Solution for 120 120mg / 0.8ml 120 bd 0.80
4 Injection 150mg/ml
120 120mg / 0.8ml (1) 120 bd (1) 0.80 (1)
CLEXANE 125 150mg / 1ml 125 bd 0.84 Solution for
Forte Injection
syringes 130 150mg / 1ml 130 bd 0.88 CLEXANE 125 150mg / 1ml (1) 125 bd (1) 0.84 (1)
Forte 150mg / 1ml (1) 130 bd (1) 0.88 (1)
135 150mg / 1ml 135 bd 0.90 130
syringes
140 150mg / 1ml 140 bd 0.94 135 150mg / 1ml (1) 135 bd (1) 0.90 (1)
145 150mg / 1ml 145 bd 0.98 140 150mg / 1ml (1) 140 bd (1) 0.94 (1)
150 150mg / 1ml 150 bd 1.00
145 150mg / 1ml (1) 145 bd (1) 0.98 (1)
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 150 150mg / 1ml (1) 150 bd (1) 1.00 (1)
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction (1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed by
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose 1mg/kg dosing for the remaining doses)
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2 on the syringe and so some of the volumes recommended in this table have been rounded up to the
‘Posology and method of administration: Elderly’. nearest graduation.

When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin
Dosage chart for 1mg/kg SC treatment of STEMI 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.
Injection
Patient Kg Syringe label Dose (mg)
volume (ml) The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
weight
whichever comes first.
40 40mg / 0.4ml 40 bd 0.40
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
45 60mg / 0.6ml 45 bd 0.45 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
50 60mg / 0.6ml 50 bd 0.50 0.3mg/kg of enoxaparin sodium should be administered.
55 60mg / 0.6ml 55 bd 0.55 Prevention of extracorporeal thrombus formation during haemodialysis:
100mg/ml A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis
60 60mg / 0.6ml 60 bd 0.60
Solution for session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than
Injection 65 80mg / 0.8ml 65 bd 0.65 normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a high
CLEXANE risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or
syringes 70 80mg / 0.8ml 70 bd 0.70 0.75 mg/kg (75 IU/kg) for single vascular access.

75 80mg / 0.8ml 75 bd 0.75 Elderly:

For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of
80 80mg / 0.8ml 80 bd 0.80 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).
85 100mg / 1ml 85 bd 0.85
For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is
90 100mg / 1ml 90 bd 0.90 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
95 100mg / 1ml 95 bd 0.95 Monitoring’, section 5.2 ‘Pharmacokinetic properties’).
100 100mg / 1ml 100 bd 1.00
 3) Stopping blood clots forming in the tubes 2) Sit or lie in a 6) Hold the syringe so that the needle is pointing
of your dialysis machine comfortable position downwards (vertically at a 90º angle). Insert the
The usual dose is 1mg for every kilogram of your so you are relaxed. full length of the needle into the skin fold.
weight Make sure you can 7) Press down on the plunger with your thumb.
Clexane is added to the tube leaving the see the place you are This will send the medication into the fatty
body (arterial line) at the start of the dialysis going to inject. A tissue of the stomach. Make sure you hold the
session lounge chair, recliner, skin fold throughout the injection.
This amount is usually enough for a 4 hour or bed propped up with pillows is ideal.
session. However, your doctor may give you a 3) Choose an area on the right or left side of
further dose of 0.5 to 1mg for every kilogram your stomach. This should be at least 5
of your weight if necessary centimetres away from your belly button and
How to give yourself an injection of Clexane out towards your sides.
If you are able to give Clexane to yourself, your Remember: Do not inject yourself within 5
doctor or nurse will show you how to do this. Do centimetres of your belly button or around 8) Remove the needle by pulling it straight out.
not try to inject yourself if you have not been existing scars or bruises. Change the place You can now let go of the skin fold. To avoid
trained how to do so. If you are not sure what to where you inject between the left and right bruising, do not rub the injection site after
do, talk to your doctor or nurse immediately. sides of your stomach, depending on the you have injected yourself.
Before injecting yourself with Clexane area you were last injected. 9) Drop the used syringe into the sharps bin
 Check the expiry date on the medicine. Do 4) Carefully pull off the needle cap from the provided. Close the container lid tightly and
not use if the date has passed Clexane syringe. Throw away the cap. The place the container out of reach of children.
 Check the syringe is not damaged and the syringe is pre-filled and ready to use. When the container is full, give it to your
medicine in it is a clear solution. If not, use doctor or home care nurse for disposal. Do
another syringe not put it in the household rubbish.
 Make sure you know how much you are
If you have too much or too little Clexane
going to inject
If you think that you have used too much or too
 Check your abdomen to see if the last
little Clexane, tell your doctor, nurse or
injection caused any redness, change in
pharmacist immediately, even if you have no
skin colour, swelling, oozing or is still painful,
signs of a problem. If a child accidentally injects
if so talk to your doctor or nurse Do not press on the plunger before injecting or swallows Clexane, take them to a hospital
 Decide where you are going to inject the yourself to get rid of air bubbles. This can lead casualty department straight away.
medicine. Change the place where you to a loss of the medicine. Once you have
inject each time from the right to the left side removed the cap, do not allow the needle to If you forget to use Clexane
of your stomach. Clexane should be injected touch anything. This is to make sure the needle If you forget to give yourself a dose, have it as
just under the skin on your stomach, but not stays clean (sterile). soon as you remember. Do not give yourself a
too near the belly button or any scar tissue double dose on the same day to make up for a
5) Hold the syringe in the hand you write with (like forgotten dose. Keeping a diary will help to
(at least 5 cm away from these)
a pencil) and with your other hand, gently pinch make sure you do not miss a dose
Instructions on injecting yourself with the cleaned area of your abdomen between
Clexane: your forefinger and thumb to make a fold in the If you stop using Clexane
skin It is important for you to keep having Clexane
1) Wash your hands and the area that you
injections until your doctor decides to stop
will inject with soap and water. Dry them.
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
Make sure you hold the skin fold throughout having Clexane.
the injection.

1
7 Dosage chart for 0.75mg/kg SC treatment of STEMI (elderly patients aged ≥75 years only) Dosage adjustments for therapeutic dosage range

1 Patient 0.75mg/kg Dose Adjusted Injection Standard dosing Severe renal impairment
Kg Syringe label
weight (mg) dosing (mg) volume (ml) 1mg/kg SC twice daily 1mg/kg SC once daily
5 1.5mg/kg SC once daily 1mg/kg SC once daily
40 60mg / 0.6ml 30 bd 30 bd 0.30
6 For treatment of acute STEMI in patients <75 years of age
45 60mg / 0.6ml 33.75 bd 35 bd 0.35
6 50 60mg / 0.6ml 37.5 bd 37.5 bd 0.375 30mg-single IV bolus plus a 1mg/kg SC dose
30mg-single IV bolus plus a
1mg/kg SC dose followed by
0 followed by 1mg/kg twice daily.
55 60mg / 0.6ml 41.25 bd 42.5 bd 0.425 1mg/kg once daily
(Max 100mg for first SC dose
4 60 60mg / 0.6ml 45 bd 45 bd 0.45
(Max 100mg for each of the first two SC doses)
only)
65 60mg / 0.6ml 48.75 bd 50 bd 0.5 For treatment of acute STEMI in elderly patients ≥75 years of age
1mg/kg SC once daily without
70 60mg / 0.6ml 52.5 bd 52.5 bd 0.525 0.75mg/kg SC twice daily without initial bolus.
initial bolus.
75 60mg / 0.6ml 56.25 bd 57.5 bd 0.575 (Max 100mg for first SC dose
(Max 75mg for each of the first two SC doses)
100mg/ml only)
Solution for 80 60mg / 0.6ml 60 bd 60 bd 0.60
Injection
85 80mg / 0.8ml 63.75 bd 65 bd 0.65
CLEXANE Dosage adjustments for prophylactic dosage ranges
syringes 90 80mg / 0.8ml 67.5 bd 67.5 bd 0.675
95 80mg / 0.8ml 71.25 bd 72.5 bd 0.725 Standard dosing Severe renal impairment

100 80mg / 0.8ml 75 bd 75 bd 0.75 40mg SC once daily 20mg SC once daily
20mg SC once daily 20mg SC once daily
105 80mg / 0.8ml 78.75 bd (1) 80 bd (1) 0.80 (1)
110 100mg / 1ml 82.5 bd (1) 82.5 bd (1) 0.825 (1) The recommended dosage adjustments do not apply to the haemodialysis indication.
115 100mg / 1ml 86.25 bd (1) 87.5 bd (1) 0.875 (1)
Moderate and mild renal impairment:
120 100mg / 1ml 90 bd (1) 90 bd (1) 0.90 (1) 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),
125 100mg / 1ml 93.75 bd (1) 95 bd (1) 0.95 (1) careful clinical monitoring is advised.
130 100mg / 1ml 97.5 bd (1) 97.5 bd (1) 0.975 (1)
Spinal/epidural anaesthesia:
150mg/ml
Solution for
135 120mg / 0.8ml 101.25 bd (1) 102 bd (1) 0.68 (1) For patients receiving spinal/epidural anaesthesia see section 4.4 ‘Special warnings and
Injection 140 120mg / 0.8ml 105 bd (1) 105 bd (1) 0.7 (1) precautions for use:’ Spinal/epidural anaesthesia.
CLEXANE Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Forte 145 120mg / 0.8ml 108.75 bd (1) 111 bd (1) 0.74 (1)
Body weight:
syringes 150 120mg / 0.8ml 112.5 bd (1) 114 bd (1) 0.76 (1) 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’).
(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) Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave
on the syringe and so some of the volumes recommended in this table have been rounded up to the myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial
nearest graduation. line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation
Children: Not recommended, as dosage not established. during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for
Renal impairment: (See also section 4.4 ‘Special warnings and precautions for use: Renal impairment the initial dose of acute STEMI indication and before PCI when needed. It must not be
and Monitoring’, section 5.2 ‘Pharmacokinetic properties’). administered by the intramuscular route.
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. Possible side effects Rare (affects less than 1 in a 1000 people) 5. How to store Clexane
If you have a mechanical heart valve,
treatment with Clexane might not be Keep out of the sight and reach of children.
Like all medicines, Clexane can cause side
sufficient to prevent blood clots. You may Do not use Clexane after the expiry date which
effects, although not everybody gets them.
notice that you have difficulty breathing, is stated on the carton and blister label after
Tell a nurse or doctor or go to hospital
tiredness or difficulty exercising, chest pain, ‘Exp’. The expiry date refers to the last day of
straight away if you notice any of the
numbness, feeling sick or loss of that month.
following side effects:
consciousness. This could be due to a blood Do not store above 25°C.
Very common (affects more than 1 in 10 Do not refrigerate. Do not freeze.
clot on the heart valve
people) Medicines should not be disposed of via
Bleeding a lot from a wound. Frequency unknown wastewater or household waste. If you are
Feeling tired, faint, dizzy, having pale skin. using this medicine at home you will be given a
Common (affects 1 to 10 people in a 100)
These could be symptoms of anaemia. container (a sharps bin) to use for disposal.
A painful rash of dark red spots under the
You notice yellowing of your skin or eyes Return the sharps bin or any used or unused
skin which do not go away when you put
and your urine becomes darker in colour. syringes to your doctor or nurse or pharmacist
pressure on them. You may also notice pink
This could be a liver problem. for disposal. These measures will help to
patches on your skin. These are more likely
to appear in the area you have been injected Other side effects that you should discuss protect the environment.
with Clexane. with your nurse or doctor if you are
6. Further Information
concerned about them:
Uncommon (affects 1 to 10 people in a 1,000) What Clexane contains
Sudden severe headache. This could be a Very common (affects more than 1 in 10 The active ingredient in clexane is enoxaparin
sign of bleeding in the brain. people) sodium. Each pre-filled syringe contains 60mg
A feeling of tenderness and swelling in your Changes in the results of blood tests done to enoxaparin sodium (equivalent to 6,000 IU anti-
stomach. You may have bleeding inside check how your liver is working. These Xa activity) in 0.6ml water for injections.
your stomach. usually go back to normal after you stop The other inactive ingredient is water for
having Clexane. injections.
Rare (affects less than 1 in a 1000 people)
Rare (affects less than 1 in a 1000 people) What Clexane looks like and contents of the
If you have an allergic reaction. The signs
Changes in the potassium levels in your pack
may include: a rash, swallowing or breathing
blood. This is more likely to happen in Clexane clear, colourless to pale yellow solution
problems, swelling of your lips, face, throat
people with kidney problems or diabetes. for injection in a glass pre-filled syringe fitted
or tongue.
Your doctor will be able to check this by with an injection needle and needle cap. It is
Frequency unknown carrying out a blood test. supplied in packs of 10 syringes.
If you have had a spinal puncture or a spinal Frequency unknown
anaesthetic and notice tingling, numbness Manufactured by: Sanofi Winthrop Industrie,
If Clexane is used for a long period of time
and muscular weakness, particularly in the 180 rue Jean-Jaures, 94702 Maisons Alfort
(more than 3 months), it may increase the
lower part of your body. Also if you lose France. Or
risk of you getting a condition called
control over your bladder or bowel (so you Sanofi Winthrop Industrie, Boulevard Industriel,
‘osteoporosis’. This is when your bones are
cannot control when you go to the toilet). 76580 Le Trait, France.
more likely to break
Tell a nurse or doctor as soon as possible if Headache Procured from within the EU and
you notice any of the following side effects: Hair loss repackaged by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road,
Common (affects 1 to 10 people in a 100) Reporting of side effects Ruislip, Middlesex, HA4 0NU, UK.
You bruise more easily than usual. This If you get any side effects, talk to your doctor, ®
Clexane 60mg/0.6ml Syringes
could be because of a blood problem pharmacist or nurse. This includes any possible PL 18799/2375
(thrombocytopenia). side effects not listed in this leaflet. You can POM
Leaflet date: 12.02.2016
You have pain, swelling or irritation in the also report side effects directly via the Yellow
Clexane is a registered trade mark of
area you have been injected with Clexane. Card Scheme at: www.mhra.gov.uk/yellowcard.
sanofi-aventis.
This normally gets better after a few days. By reporting side effects, you can help provide
more information on the safety of this medicine.


1 Subcutaneous injection technique
7 The pre-filled disposable syringe is ready for immediate use. Clexane should be administered when Volume to inject Volume to inject
the patient is lying down by deep subcutaneous injection. The administration should be alternated Required when diluted to a when diluted to a
1 between the left and right anterolateral or posterolateral abdominal wall. The whole length of the Weight dose final Weight
Required dose
final
needle should be introduced vertically into a skin fold held between the thumb and index finger. The (0.3mg/kg)
5 (0.3mg/kg) concentration of concentration of
skin fold should not be released until the injection is complete. 3mg/ml 3mg/ml
6 Once the plunger is fully pressed down the safety device is activated automatically. This protects
(Kg) (mg) (ml) (Kg) (mg) (ml)
the used needle.
6 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. 45 13.5 4.5 100 30 10
0
50 15 5 105 31.5 10.5
4 Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg pre-filled syringes can 55 16.5 5.5 110 33 11
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 60 18 6 115 34.5 11.5
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 65 19.5 6.5 120 36 12
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. 70 21 7 125 37.5 12.5

Initial 30mg bolus 75 22.5 7.5 130 39 13

For the initial 30mg bolus, using an enoxaparin sodium graduated pre-filled syringe (60, 80 or
100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The 30mg dose can 80 24 8 135 40.5 13.5
then be directly injected into an injection site in the intravenous line.
85 25.5 8.5 140 42 14
Additional bolus for PCI when last SC administration was given more than 8 hours 90 27 9 145 43.5 14.5
before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus 95 28.5 9.5 150 45 15
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’).
6 PHARMACEUTICAL PARTICULARS
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the
6.1 List of excipients
drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium pre-filled syringe, it is recommended Water for Injections
to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) 6.2 Incompatibilities
as follows: Subcutaneous Injection
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete Clexane should not be mixed with any other injections or infusions.
contents of the 60mg enoxaparin sodium pre-filled syringe into the 20ml remaining in the bag. Intravenous (Bolus) Injection for acute STEMI indication only
Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose in
for administration into the intravenous line (using an appropriate injection site or port). water.
After dilution is completed, the volume to be injected can be calculated using the following formula
6.3 Shelf life
[Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is
36 months
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 6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
Clexane pre-filled syringes are single dose containers - discard any unused product
6.5 Nature and contents of container
Solution for injection in Type I glass pre-filled syringe in pack of 10.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
7 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8 DATE OF REVISION OF THE TEXT: 12.02.2016
 PACKAGE LEAFLET: Enoxaparin sodium can be used to: Take special care with Enoxaparin
INFORMATION FOR THE USER Treat blood clots that are in your blood sodium
Stop blood clots forming in your blood in the Check with your doctor or pharmacist or
Enoxaparin sodium 60mg/0.6ml following situations: nurse before using this medicine if:
Syringes Unstable angina (where not enough
 You have high blood pressure
blood gets to your heart)
Read all of this leaflet carefully before you  You have kidney problems
After an operation or long periods of
start using this medicine
bed rest due to illness  You have had a heart valve fitted
Keep this leaflet. You may need to read it  You have ever had bruising and bleeding
After you have had a heart attack
again caused by the medicine ‘heparin’
Stop blood clots forming in the tubes of your
If you have any further questions, ask your  You have ever had a stroke
dialysis machine (used for people with
doctor or pharmacist  You have ever had a stomach ulcer
kidney problems)
This medicine has been prescribed for you.  You have recently had an operation on your
Do not pass it on to others. It may harm 2. Before you use Enoxaparin sodium eyes or brain
them, even if their symptoms are the same  You are a diabetic or have an illness known
as yours Do not have this medicine and tell your as ‘diabetic retinopathy’ (problems with the
If any of the side effects get serious, or if doctor, pharmacist or nurse if: blood vessels in the eye caused by
you notice any side effects not listed in this You are allergic (hypersensitive) to diabetes)
leaflet, please tell your doctor or pharmacist enoxaparin sodium or any of the other  You have any problems with your blood
ingredients of Enoxaparin sodium (listed in  You are underweight or overweight
Please note that the leaflet also contains
Section 6: ‘Further information’)  You are elderly (over 65 years old) and
information about other strengths, Enoxaparin
Signs of an allergic reaction include: a rash, especially if you are aged over 75 years old
sodium 20mg, 40mg and 80mg and 100mg
swallowing or breathing problems, swelling of If you are not sure if any of the above applies to
Syringes.
your lips, face, throat or tongue you, talk to your doctor or pharmacist or nurse
In this leaflet: before using Enoxaparin sodium.
1. What Enoxaparin sodium is and what it is You are allergic to heparin or other Low
used for Molecular Weight Heparins such as Taking or using other medicines
2. Before you use Enoxaparin sodium tinzaparin or dalteparin
Please tell your doctor, pharmacist or nurse if
3. How to use Enoxaparin sodium You have a problem with bruising or you are taking or have recently taken any other
4. Possible side effects bleeding too easily medicines. This includes medicines you buy
5. How to store Enoxaparin sodium You have an ulcer in your stomach or gut without a prescription, including herbal
6. Further information (intestine) medicines. This is because Enoxaparin sodium
You have had a stroke caused by bleeding can affect the way some other medicines work.
1. What Enoxaparin sodium is in the brain Also some medicines can affect the way
You have an infection in your heart Enoxaparin sodium works.
and what it is used for
You are using the medicine called heparin to In particular, do not have this medicine
The name of your medicine is Enoxaparin treat blood clots and tell your doctor if:
sodium 60mg/0.6ml Syringes but it will be Do not have this medicine if any of the above You are using the medicine called
referred as Enoxaparin sodium throughout this apply to you. If you are not sure, talk to your heparin to treat blood clots
leaflet. Enoxaparin sodium contains a medicine doctor, pharmacist or nurse before having Tell your doctor if you are taking any of
called enoxaparin sodium. This belongs to a Enoxaparin sodium. the following medicines:
group of medicines called Low Molecular Warfarin - used for thinning the blood
Weight Heparins.
Aspirin, dipyridamole, clopidogrel or other
Enoxaparin sodium works in two ways. medicines – used to stop blood clots
1) Stopping existing blood clots from getting forming
any bigger. This helps your body to break
them down and stop them causing you
harm.
2) Stopping blood clots forming in your blood.


1
7 THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY
Enoxaparin sodium 60mg/0.6ml Syringes Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
1
5 The following information is extracted from the SPC Patient Injection
Kg Syringe label Dose (mg)
weight volume (ml)
Technical information for the administration of Enoxaparin sodium Syringes
6
70 120mg / 0.8ml 105 od 0.70
6 1 NAME OF THE MEDICINAL PRODUCT
Enoxaparin sodium 60mg/0.6ml Syringes 150mg/ml 75 120mg / 0.8ml 112.5 od 0.76
Solution for
0 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Injection 80 120mg / 0.8ml 120 od 0.80
4 Pre-filled syringes: ENOXAPARIN
60mg Injection Enoxaparin sodium 60mg (equivalent to 6,000 IU anti-Xa activity) in 0.6ml Water for SODIUM 85 150mg / 1ml 127.5 od 0.86
Injections Forte
syringes 90 150mg / 1ml 135 od 0.90
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM 95 150mg / 1ml 142.5 od 0.96
Solution for injection. 100 150mg/ 1ml 150 od 1.00
Clear, colourless to pale yellow solution.
4.2 Posology and method of administration Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
Adults: on the syringe and so some of the volumes recommended in this table have been rounded up to the
Prophylaxis of venous thromboembolism: nearest graduation.
In patients with a low to moderate risk of venous thromboembolism the recommended dosage is
20mg (2,000IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of Treatment of unstable angina and non-Q-wave myocardial infarction
thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given The recommended dose is 1mg/kg Enoxaparin sodium every 12 hours by subcutaneous injection,
approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery, administered concurrently with oral aspirin (100 to 325mg once daily). Treatment with Enoxaparin
the dosage should be 40mg (4,000IU) daily by subcutaneous injection with the initial dose sodium in these patients should be prescribed for a minimum of 2 days and continued until clinical
administered approximately 12 hours before surgery. stabilisation. The usual duration of treatment is 2 to 8 days.
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 Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
40mg (4,000IU) once daily by subcutaneous injection for 4 weeks with the initial dose administered
approximately 12 hours before surgery. Patient Injection
Prophylaxis of venous thromboembolism in medical patients: Kg Syringe label Dose (mg)
weight volume (ml)
The recommended dose of enoxaparin sodium is 40mg (4,000 IU) once daily by subcutaneous
injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued 40 40mg / 0.4ml 40 bd 0.40
until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism: 45 60mg / 0.6ml 45 bd 0.45
Enoxaparin sodium should be administered subcutaneously as a single daily injection of 1.5mg/kg
(150IU/kg). Enoxaparin sodium treatment is usually prescribed for at least 5 days and until adequate 50 60mg / 0.6ml 50 bd 0.50
oral anticoagulation is established.
55 60mg / 0.6ml 55 bd 0.55
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
60 60mg / 0.6ml 60 bd 0.60
Patient Injection 100mg/ml
Kg Syringe label Dose (mg) 65 80mg / 0.8ml 65 bd 0.65
weight volume (ml) Solution for
Injection
ENOXAPARIN 70 80mg / 0.8ml 70 bd 0.70
40 60mg / 0.6ml 60 od 0.60
SODIUM
75 80mg / 0.8ml 75 bd 0.75
syringes
45 80mg / 0.8ml 67.5 od 0.675
100mg/ml 80 80mg / 0.8ml 80 bd 0.80
Solution for 50 80mg / 0.8ml 75 od 0.75
Injection 85 100mg / 1ml 85 bd 0.85
ENOXAPARIN SODIUM 55 100mg / 1ml 82.5 od 0.825
syringes 90 100mg / 1ml 90 bd 0.90
60 100mg / 1ml 90 od 0.90
95 100mg / 1ml 95 bd 0.95
65 100mg / 1ml 97.5 od 0.975
100 100mg / 1ml 100 bd 1.00
 Dextran injection - used as a blood replacer When you go home you may need to If you are bedridden due to illness, you will
Ibuprofen, diclofenac, ketorolac or other continue to use Enoxaparin sodium and give be normally be given 40mg of Enoxaparin
medicines – used to treat pain and swelling it to yourself (see below instructions on how sodium each day for 6 to 14 days
in arthritis and other illnesses to do this) c) After you have had a heart attack
Prednisolone, dexamethasone or other Enoxaparin sodium is usually given by Enoxaparin sodium can be used for two
medicines – used to treat asthma, injection underneath the skin different types of heart attack called NSTEMI or
rheumatoid arthritis and other conditions (subcutaneous) STEMI.
Water tablets (diuretics) such as Do not inject Enoxaparin sodium into a The amount of Enoxaparin sodium given to you
spironolactone, triamterene or amiloride. muscle (intramuscular) will depend on your age and the kind of heart
These may increase the levels of potassium If you are not sure why you are receiving attack you have had.
in your blood when taken with Enoxaparin Enoxaparin sodium or have any questions i) NSTEMI type of heart attack
sodium about how much Enoxaparin sodium is being The usual amount is 1mg for every kilogram
Your doctor may change one of your medicines given to you, speak to your doctor, pharmacist of weight, every 12 hours
or take regular blood tests to check that taking or nurse. Enoxaparin sodium will usually be given for
these medicines with Enoxaparin sodium is not How much will be given to you 2 to 8 days. Your doctor will normally ask
causing you any harm. Your doctor will decide how much to give you to take aspirin as well
Operations and anaesthetics you. The amount of Enoxaparin sodium ii) STEMI type of heart attack
If you are going to have a spinal puncture or an given to you will depend on the reason it is If you are under 75 years old
operation where an epidural or spinal being used 30mg of Enoxaparin sodium will be given as
anaesthetic is used, tell your doctor that you are an injection into your vein (intravenous
If you have problems with your kidneys, you
using Enoxaparin sodium. Tell also your doctor injection using Enoxaparin sodium Multidose
may be given a smaller amount of
if you have any problem with your spine or if Vial or 60, 80 or 100mg Pre-filled syringes)
Enoxaparin sodium
you have ever had spinal surgery. At the same time, you will also be given
1) Treating blood clots that are in your blood Enoxaparin sodium as an injection under
Pregnancy and breast-feeding The usual dose is 1.5mg for every kilogram your skin (subcutaneous injection). The
Talk to your doctor before you use this medicine of your weight, each day usual dose is 1mg for every kilogram of your
if you are pregnant, might become pregnant, or Enoxaparin sodium will usually be given for weight.
think you may be pregnant. at least 5 days Then you will be given 1mg for every kilogram of
You should not use this medicine if you are pregnant 2) Stopping blood clots forming in your your weight every 12 hours
and have a mechanical heart valve as you may be at blood in the following situations: The maximum amount of Enoxaparin
increased risk of developing blood clots. Your doctor a) Unstable angina sodium given for the first two injections is
should discuss this with you. The usual amount is 1mg for every kilogram 100mg
You should not breast-feed whilst using of weight, every 12 hours The injections will normally be given for up
Enoxaparin sodium. If you are planning to Enoxaparin sodium will usually be given for to 8 days
breast-feed, talk to your doctor, pharmacist or 2 to 8 days. Your doctor will normally ask If you are aged 75 years or older
nurse. you to take aspirin as well Your doctor or nurse will give you injections
b) After an operation or long periods of of Enoxaparin sodium under your skin
Ask your doctor or pharmacist for advice before
bedrest due to illness (subcutaneous injection)
taking any medicine if you are pregnant or
The usual dose is 20mg or 40mg each day. The usual dose is 0.75mg for every kilogram
breast-feeding.
The dose will depend on how likely you are of your weight, every 12 hours
3. How to use Enoxaparin sodium to develop a clot The maximum amount of Enoxaparin
If you have a low to medium risk of getting a sodium given for the first two injections is
Having this medicine clot, you will be given 20mg of Enoxaparin 75mg
Before you use Enoxaparin sodium your sodium each day for 7 to 10 days. If you are For patients having an operation called
doctor or nurse may carry out a blood test going to have an operation, your first Percutaneous Coronary Intervention (PCI)
While you are in hospital your doctor or injection will usually be given 2 hours before Depending on when you were last given
nurse will normally give you Enoxaparin your operation Enoxaparin sodium, your doctor may decide
sodium. This is because it needs to be given If you have a higher risk of getting a clot, to give an additional dose of Enoxaparin
as an injection you will be given 40mg each day for 7 to 28 sodium before a PCI operation. This is by
days. If you are going to have an operation, injection into your vein (intravenous using
your first injection will usually be given 12 Enoxaparin sodium Multidose Vial or 60, 80
hours before your operation or 100mg Pre-filled syringes)

1
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI Dosage chart for 1mg/kg SC treatment of STEMI
7
Patient Injection
1 weight
Kg Syringe label Dose (mg)
volume (ml)
Patient
Kg Syringe label Dose (mg)
Injection
weight volume (ml)
5 105 120mg / 0.8ml 105 bd 0.70
6 105 120mg / 0.8ml (1) 105 bd (1) 0.70 (1)
110 120mg / 0.8ml 110 bd 0.74
6 115 120mg / 0.8ml 115 bd 0.78
110 120mg / 0.8ml (1) 110 bd (1) 0.74 (1)
150mg/ml
0 Solution for 120 120mg / 0.8ml 120 bd 0.80 150mg/ml
115 120mg / 0.8ml (1) 115 bd (1) 0.78 (1)
Injection
4 ENOXAPARIN
Solution for 120 120mg / 0.8ml (1) 120 bd (1) 0.80 (1)
125 150mg / 1ml 125 bd 0.84 Injection
SODIUM
Forte ENOXAPARIN 125 150mg / 1ml (1) 125 bd (1) 0.84 (1)
130 150mg / 1ml 130 bd 0.88
syringes SODIUM
135 150mg / 1ml 135 bd 0.90 Forte 130 150mg / 1ml (1) 130 bd (1) 0.88 (1)
syringes
140 150mg / 1ml 140 bd 0.94 135 150mg / 1ml (1) 135 bd (1) 0.90 (1)
145 150mg / 1ml 145 bd 0.98 140 150mg / 1ml (1) 140 bd (1) 0.94 (1)
150 150mg / 1ml 150 bd 1.00 145 150mg / 1ml (1) 145 bd (1) 0.98 (1)
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations 150 150mg / 1ml (1) 150 bd (1) 1.00 (1)
on the syringe and so some of the volumes recommended in this table have been rounded up to the
nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose (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)
followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations
by 1mg/kg dosing for the remaining doses). For dosage in patients ≥75 years of age, see section 4.2 on the syringe and so some of the volumes recommended in this table have been rounded up to the
‘Posology and method of administration: Elderly’. nearest graduation.
Dosage chart for 1mg/kg SC treatment of STEMI 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
Injection STEMI and maintained under (75 to 325mg once daily) unless contraindicated.
Patient Kg Syringe label Dose (mg)
volume (ml)
weight The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge,
40 40mg / 0.4ml 40 bd 0.40 whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium
45 60mg / 0.6ml 45 bd 0.45 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
50 60mg / 0.6ml 50 bd 0.50
0.3mg/kg of enoxaparin sodium should be administered.
55 60mg / 0.6ml 55 bd 0.55 Prevention of extracorporeal thrombus formation during haemodialysis:
100mg/ml A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis
Solution for 60 60mg / 0.6ml 60 bd 0.60 session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than
Injection normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a high
ENOXAPARIN 65 80mg / 0.8ml 65 bd 0.65
risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or
SODIUM 70 80mg / 0.8ml 70 bd 0.70 0.75 mg/kg (75 IU/kg) for single vascular access.
syringes
75 80mg / 0.8ml 75 bd 0.75 Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75 years of
80 80mg / 0.8ml 80 bd 0.80 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).
85 100mg / 1ml 85 bd 0.85 For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is
90 100mg / 1ml 90 bd 0.90 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
95 100mg / 1ml 95 bd 0.95 Monitoring’, section 5.2 ‘Pharmacokinetic properties’).
100 100mg / 1ml 100 bd 1.00
 3) Stopping blood clots forming in the tubes 2) Sit or lie in a 6) Hold the syringe so that the needle is pointing
of your dialysis machine comfortable position downwards (vertically at a 90º angle). Insert the
The usual dose is 1mg for every kilogram of your so you are relaxed. full length of the needle into the skin fold.
weight Make sure you can 7) Press down on the plunger with your thumb.
Enoxaparin sodium is added to the tube see the place you are This will send the medication into the fatty
leaving the body (arterial line) at the start of going to inject. A tissue of the stomach. Make sure you hold the
the dialysis session lounge chair, recliner, skin fold throughout the injection.
This amount is usually enough for a 4 hour or bed propped up with pillows is ideal.
session. However, your doctor may give you a 3) Choose an area on the right or left side of
further dose of 0.5 to 1mg for every kilogram your stomach. This should be at least 5
of your weight if necessary centimetres away from your belly button and
How to give yourself an injection of out towards your sides.
Enoxaparin sodium Remember: Do not inject yourself within 5
If you are able to give Enoxaparin sodium to centimetres of your belly button or around 8) Remove the needle by pulling it straight out.
yourself, your doctor or nurse will show you existing scars or bruises. Change the place You can now let go of the skin fold. To avoid
how to do this. Do not try to inject yourself if you where you inject between the left and right bruising, do not rub the injection site after
have not been trained how to do so. If you are sides of your stomach, depending on the you have injected yourself.
not sure what to do, talk to your doctor or nurse area you were last injected. 9) Drop the used syringe into the sharps bin
immediately. 4) Carefully pull off the needle cap from the provided. Close the container lid tightly and
Before injecting yourself with Enoxaparin Enoxaparin sodium syringe. Throw away the place the container out of reach of children.
sodium cap. The syringe is pre-filled and ready to When the container is full, give it to your
 Check the expiry date on the medicine. Do use. doctor or home care nurse for disposal. Do
not use if the date has passed not put it in the household rubbish.
 Check the syringe is not damaged and the
If you have too much or too little Enoxaparin
medicine in it is a clear solution. If not, use
sodium
another syringe
If you think that you have used too much or too
 Make sure you know how much you are
little Enoxaparin sodium, tell your doctor, nurse
going to inject
or pharmacist immediately, even if you have no
 Check your abdomen to see if the last
signs of a problem. If a child accidentally injects
injection caused any redness, change in Do not press on the plunger before injecting or swallows Enoxaparin sodium, take them to a
skin colour, swelling, oozing or is still painful, yourself to get rid of air bubbles. This can lead hospital casualty department straight away.
if so talk to your doctor or nurse to a loss of the medicine. Once you have
 Decide where you are going to inject the removed the cap, do not allow the needle to If you forget to use Enoxaparin sodium
medicine. Change the place where you touch anything. This is to make sure the needle If you forget to give yourself a dose, have it as
inject each time from the right to the left side stays clean (sterile). soon as you remember. Do not give yourself a
of your stomach. Enoxaparin sodium should double dose on the same day to make up for a
5) Hold the syringe in the hand you write with (like forgotten dose. Keeping a diary will help to
be injected just under the skin on your
a pencil) and with your other hand, gently pinch make sure you do not miss a dose
stomach, but not too near the belly button or
the cleaned area of your abdomen between
any scar tissue (at least 5 cm away from If you stop using Enoxaparin sodium
your forefinger and thumb to make a fold in the
these) It is important for you to keep having
skin
Instructions on injecting yourself with Enoxaparin sodium injections until your doctor
Enoxaparin sodium: decides to stop them. If you stop, you could get
a blood clot which can be very dangerous.
1) Wash your hands and the area that you
Blood Tests
will inject with soap and water. Dry them.
Using Enoxaparin sodium 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
Make sure you hold the skin fold throughout are having Enoxaparin sodium.
the injection.


1
7 Dosage chart for 0.75mg/kg SC treatment of STEMI (elderly patients aged ≥75 years only) Dosage adjustments for therapeutic dosage range

1 Patient 0.75mg/kg Dose Adjusted Injection Standard dosing Severe renal impairment
Kg Syringe label
weight (mg) dosing (mg) volume (ml) 1mg/kg SC twice daily 1mg/kg SC once daily
5 1.5mg/kg SC once daily 1mg/kg SC once daily
40 60mg / 0.6ml 30 bd 30 bd 0.30
6 45 60mg / 0.6ml 33.75 bd 35 bd 0.35 For treatment of acute STEMI in patients <75 years of age
6 50 60mg / 0.6ml 37.5 bd 37.5 bd 0.375
30mg-single IV bolus plus a 1mg/kg SC dose 30mg-single IV bolus plus a 1mg/kg SC
followed by 1mg/kg twice daily. dose followed by 1mg/kg once daily
0 55 60mg / 0.6ml 41.25 bd 42.5 bd 0.425 (Max 100mg for each of the first two SC doses) (Max 100mg for first SC dose only)
4 60 60mg / 0.6ml 45 bd 45 bd 0.45 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.
65 60mg / 0.6ml 48.75 bd 50 bd 0.5
(Max 75mg for each of the first two SC doses) (Max 100mg for first SC dose only)
70 60mg / 0.6ml 52.5 bd 52.5 bd 0.525
75 60mg / 0.6ml 56.25 bd 57.5 bd 0.575 Dosage adjustments for prophylactic dosage ranges
100mg/ml
Solution for 80 60mg / 0.6ml 60 bd 60 bd 0.60
Injection Standard dosing Severe renal impairment
ENOXAPARIN 85 80mg / 0.8ml 63.75 bd 65 bd 0.65
SODIUM 40mg SC once daily 20mg SC once daily
syringes 90 80mg / 0.8ml 67.5 bd 67.5 bd 0.675 20mg SC once daily 20mg SC once daily
95 80mg / 0.8ml 71.25 bd 72.5 bd 0.725
The recommended dosage adjustments do not apply to the haemodialysis indication.
100 80mg / 0.8ml 75 bd 75 bd 0.75
Moderate and mild renal impairment:
105 80mg / 0.8ml 78.75 bd (1) 80 bd (1) 0.80 (1) Although no dosage adjustments are recommended in patients with moderate renal impairment
110 100mg / 1ml 82.5 bd (1) 82.5 bd (1) 0.825 (1) (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min),
careful clinical monitoring is advised.
115 100mg / 1ml 86.25 bd (1) 87.5 bd (1) 0.875 (1)
Spinal/epidural anaesthesia:
120 100mg / 1ml 90 bd (1) 90 bd (1) 0.90 (1)
For patients receiving spinal/epidural anaesthesia see section 4.4 ‘Special warnings and
125 100mg / 1ml 93.75 bd (1) 95 bd (1) 0.95 (1) precautions for use:’ Spinal/epidural anaesthesia.
130 100mg / 1ml 97.5 bd (1) 97.5 bd (1) 0.975 (1) Hepatic impairment: In the absence of clinical studies, caution should be exercised.
150mg/ml Body weight:
Solution for 135 120mg / 0.8ml 101.25 bd (1) 102 bd (1) 0.68 (1) No dosage adjustments are recommended in obesity or low body weight (see also section 4.4
Injection ‘Special warnings and precautions for use: ‘Low body weight and Monitoring’, section 5.2
140 120mg / 0.8ml 105 bd (1) 105 bd (1) 0.7 (1)
ENOXAPARIN ‘Pharmacokinetic properties’).
SODIUM 145 120mg / 0.8ml 108.75 bd (1) 111 bd (1) 0.74 (1)
Forte Enoxaparin sodium is administered by subcutaneous injection for the prevention of venous
syringes 150 120mg / 0.8ml 112.5 bd (1) 114 bd (1) 0.76 (1)
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);
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-
0.75mg/kg dosing for the remaining doses) corporeal circulation during haemodialysis; and via intravenous (bolus) injection through an
Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations intravenous line only for the initial dose of acute STEMI indication and before PCI when needed.
on the syringe and so some of the volumes recommended in this table have been rounded up to the It must not be administered by the intramuscular route.
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. Possible side effects Rare (affects less than 1 in a 1000 people) 5. How to store Enoxaparin sodium
If you have a mechanical heart valve,
Like all medicines, Enoxaparin sodium can treatment with Enoxaparin sodium might not Keep out of the sight and reach of children.
cause side effects, although not everybody gets be sufficient to prevent blood clots. You may Do not use Enoxaparin sodium after the expiry
them. notice that you have difficulty breathing, date which is stated on the carton and blister
Tell a nurse or doctor or go to hospital tiredness or difficulty exercising, chest pain, label after ‘Exp’. The expiry date refers to the
straight away if you notice any of the numbness, feeling sick or loss of last day of that month.
following side effects: consciousness. This could be due to a blood Do not store above 25°C. Do not refrigerate or
clot on the heart valve freeze.
Very common (affects more than 1 in 10 Medicines should not be disposed of via
people) Frequency unknown
wastewater or household waste. If you are
Bleeding a lot from a wound. Feeling tired, faint, dizzy, having pale skin.
using this medicine at home you will be given a
These could be symptoms of anaemia.
Common (affects 1 to 10 people in a 100) container (a sharps bin) to use for disposal.
You notice yellowing of your skin or eyes Return the sharps bin or any used or unused
A painful rash of dark red spots under the
and your urine becomes darker in colour. syringes to your doctor or nurse or pharmacist
skin which do not go away when you put
This could be a liver problem. for disposal. These measures will help to
pressure on them. You may also notice pink
patches on your skin. These are more likely Other side effects that you should discuss protect the environment.
to appear in the area you have been injected with your nurse or doctor if you are
with Enoxaparin sodium. concerned about them: 6. Further Information
Uncommon (affects 1 to 10 people in a 1,000) Very common (affects more than 1 in 10 What Enoxaparin sodium contains
Sudden severe headache. This could be a people) The active ingredient in clexane is enoxaparin
sign of bleeding in the brain. Changes in the results of blood tests done to sodium. Each pre-filled syringe contains 60mg
check how your liver is working. These enoxaparin sodium (equivalent to 6,000 IU anti-
A feeling of tenderness and swelling in your
usually go back to normal after you stop Xa activity) in 0.6ml water for injections.
stomach. You may have bleeding inside
having Enoxaparin sodium. The other inactive ingredient is water for
your stomach.
Rare (affects less than 1 in a 1000 people) injections.
Rare (affects less than 1 in a 1000 people)
Changes in the potassium levels in your What Enoxaparin sodium looks like and
If you have an allergic reaction. The signs
blood. This is more likely to happen in contents of the pack
may include: a rash, swallowing or breathing
people with kidney problems or diabetes. Enoxaparin sodium is a clear, colourless to pale
problems, swelling of your lips, face, throat
Your doctor will be able to check this by yellow solution for injection in a glass prefilled
or tongue.
carrying out a blood test. syringe fitted with an injection needle and
Frequency unknown Frequency unknown needle cap. It is supplied in packs of 10
If you have had a spinal puncture or a spinal If Enoxaparin sodium is used for a long syringes.
anaesthetic and notice tingling, numbness period of time (more than 3 months), it may
and muscular weakness, particularly in the increase the risk of you getting a condition Manufactured by: Sanofi Winthrop Industrie,
lower part of your body. Also if you lose called ‘osteoporosis’. This is when your 180 rue Jean-Jaures, 94702 Maisons Alfort
control over your bladder or bowel (so you bones are more likely to break France. Or
cannot control when you go to the toilet). Headache Sanofi Winthrop Industrie, Boulevard Industriel,
Tell a nurse or doctor as soon as possible if Hair loss 76580 Le Trait, France.
you notice any of the following side effects: Reporting of side effects Procured from within the EU and
Common (affects 1 to 10 people in a 100) If you get any side effects, talk to your doctor, repackaged by the Product Licence holder:
You bruise more easily than usual. This pharmacist or nurse. This includes any possible B&S Healthcare, Unit 4, Bradfield Road,
could be because of a blood problem side effects not listed in this leaflet. You can Ruislip, Middlesex, HA4 0NU, UK.
(thrombocytopenia). also report side effects directly via the Yellow Enoxaparin sodium 60mg/0.6ml Syringes
You have pain, swelling or irritation in the Card Scheme at: www.mhra.gov.uk/yellowcard. PL 18799/2375
POM
area you have been injected with By reporting side effects, you can help provide Leaflet date: 12.02.2016
Enoxaparin sodium. This normally gets more information on the safety of this medicine.
better after a few days.


1 Subcutaneous injection technique
7 The prefilled disposable syringe is ready for immediate use. Enoxaparin sodium should be Volume to inject Volume to inject
administered when the patient is lying down by deep subcutaneous injection. The administration Required when diluted to a when diluted to a
1 Weight Required dose
should be alternated between the left and right anterolateral or posterolateral abdominal wall. The dose final Weight final
(0.3mg/kg)
whole length of the needle should be introduced vertically into a skin fold held between the thumb (0.3mg/kg) concentration of concentration of
5 and index finger. The skin fold should not be released until the injection is complete. 3mg/ml 3mg/ml
6 Once the plunger is fully pressed down the safety device is activated automatically. This protects
(Kg) (mg) (ml) (Kg) (mg) (ml)
the used needle.
6 Note: The plunger has to be pressed down all the way for the safety device to be activated. 45 13.5 4.5 100 30 10
Do not rub the injection site after administration.
0
50 15 5 105 31.5 10.5
4 Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can 55 16.5 5.5 110 33 11
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 60 18 6 115 34.5 11.5
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 65 19.5 6.5 120 36 12
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. 70 21 7 125 37.5 12.5

75 22.5 7.5 130 39 13

Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80 or 80 24 8 135 40.5 13.5
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. 85 25.5 8.5 140 42 14

Additional bolus for PCI when last SC administration was given more than 8 hours 90 27 9 145 43.5 14.5
before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus 95 28.5 9.5 150 45 15
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’). 6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the Water for Injections
drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended 6.2 Incompatibilities
to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) Subcutaneous Injection
as follows: Enoxaparin sodium should not be mixed with any other injections or infusions.
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete Intravenous (Bolus) Injection for acute STEMI indication only
contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml remaining in the bag. Gently Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose in
mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for water.
administration into the intravenous line (using an appropriate injection site or port). 6.3 Shelf life
After dilution is completed, the volume to be injected can be calculated using the following formula 36 months
[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 6.4 Special precautions for storage
immediately after use. Volume to be injected through intravenous line after dilution is completed Do not store above 25°C. Do not refrigerate or freeze.
Enoxaparin sodium pre-filled syringes are single dose containers - discard any unused product
6.5 Nature and contents of container
Solution for injection in Type I glass pre-filled syringe in pack of 10.
6.6 Special precautions for disposal
See section 4.2 ‘Posology and method of administration’.
7 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8 DATE OF REVISION OF THE TEXT: 12.02.2016