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PACKAGE LEAFLET:

INFORMATION FOR THE USER

Clexane* 20mg, 40mg, 60mg, 80mg and 100mg Pre-Filled Syringes

enoxaparin sodium

SANOFI v>

1. What Clexane is and what it is used for

The name of your medicine is Clexane 20mg, 40mg, 60mg, 80mg and 100mg Pre-filled Syringes (called Clexane in this leaflet). Clexane contains a medicine called enoxaparin sodium. This belongs to a group of medicines called Low Molecular Weight Heparins.

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)

♦    Afteran 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 use Clexane

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

XYou are allergic (hypersensitive) 561483 to enoxaparin sodium or any of the other ingredients of Clexane (listed in Section 6: Further information)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling ofyour lips, face, throat ortongue XYou are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin or dalteparin XYou have a problem with bruising or bleeding too easily

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

XYou have had a stroke caused by bleeding in the brain

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

Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Clexane.

a Take special care with Clexane

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

kYou have high blood pressure AYou have kidney problems kYou have had a heart valve fitted

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

_ _ _ _ _ _1

521281

569423

Clexane*20mg, 40mg, 60mg, 80mg and 100mg Pre-Filled Syringes

enoxaparin sodium

The following information is extracted from the SPC

Technical information for the administration of Clexane Syringes

1    NAME OF THE MEDICINAL PRODUCT

Clexane® Syringes

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Pre-filled syringes:

20 mg    Injection    Enoxaparin    sodium 20    mg (equivalent to 2,000    IU anti-Xa    activity) in    0.2 mLWater for    Injections

40 mg    Injection    Enoxaparin    sodium 40    mg (equivalent to 4,000    IU anti-Xa    activity) in    0.4 mLWater for    Injections

60 mg    Injection    Enoxaparin    sodium 60    mg (equivalent to 6,000    IU anti-Xa    activity) in    0.6 mLWater for    Injections

80 mg    Injection    Enoxaparin    sodium 80    mg (equivalent to 8,000    IU anti-Xa    activity) in    0.8 mLWater for    Injections

100 mg Injection Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0 mLWaterfor Injections Forfull listof excipients, see section 6.1

3    PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless to pale yellow solution.

4.2 Posology and method of administration

Adults:

Prophylaxis ofvenous thromboembolism:

In patients with a low to moderate risk ofvenous 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.

Prophvlaxisofvenousthromboembolism 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 of14days.

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.

A You have ever had a stroke

A You have ever had a stomach ulcer

A You have recently had an operation on your eyes or brain

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

A You have any problems with your blood A You are underweight or overweight

A You are elderly (over 65 years old) and especially if you are aged over 75 years old If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or nurse before using Clexane.

Taking or using other medicines

Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Clexane can affect the way some other medicines work. Also some medicines can affect the way Clexane works.

In particular, do not have this medicine and tell your doctor if: xYou are using the medicine called heparin 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 as a blood replacer

♦    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 ortake regular blood tests to check that taking these medicines with Clexane is not causing you any harm.

Operations and anaesthetics If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are using Clexane. Tell also your doctor if you have any problem with your spine or if you have ever had spinal surgery.

Pregnancy and breast-feeding

Talk to your doctor before you use 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.

3. How to use Clexane

Having this medicine

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

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

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

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

If you are not sure why you are receiving

Clexane or have any questions about how

much Clexane is being given to you, speak to

your doctor, pharmacist or nurse.

How much will be given to you

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

♦    If you have problems with your kidneys, you may be given a smaller amount of Clexane

2

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both					Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)	Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
100mg/ml Solution for Injection CLEXANE syringes	40	60mg/ 0.6ml	60 od	0.60	150mg/ml Solution for Injection CLEXANE Forte syringes	70 75 80	120mg/0.8ml 120mg/0.8ml 120mg/0.8ml	105 od 112.5 od 120 od	0.70 0.76 0.80
	45 50	80mg/ 0.8ml 80mg/ 0.8ml	67.5 od 75 od	0.675 0.75
	55 60 65	100mg/ 1ml 100mg/ 1ml 100mg/ 1ml	82.5    od 90 od 97.5    od	0.825 0.90 0.975		85 90 95 100	150mg/ 1ml 150mg/ 1ml 150mg/ 1ml 150mg/ 1ml	127.5    od 135 od 142.5    od 150 od	0.86 0.90 0.96 1.00

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been rounded up to the nearest graduation.

Treatment of unstable angina and non-O-wave myocardial infarction

The recommended dose is1 mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325mg once daily). Treatment with Clexane in these patients should be prescribed fora minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is2to8 days.

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI						Dosa	;e chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)		Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
	40	40mg/0.4ml	40 bd	0.40			105	120mg/ 0.8ml	105 bd	0.70
	45	60mg/0.6ml	45 bd	0.45			110	120mg/ 0.8ml	110 bd	0.74
	50	60mg/0.6ml	50 bd	0.50		150mg/ml	115	120mg/ 0.8ml	115 bd	0.78
	55	60mg/0.6ml	55 bd	0.55		Solution for	120	120mg/ 0.8ml	120 bd	0.80
100mg/ml	60	60mg/0.6ml	60 bd	0.60		Injection	125	150mg/ 1ml	125 bd	0.84
Solution for	65	80mg/0.8ml	65 bd	0.65		CLEXANE	130	150mg/ 1ml	130 bd	0.88
Injection	70	80mg/0.8ml	70 bd	0.70		Forte	135	150mg/ 1ml	135 bd	0.90
CLEXANE	75	80mg/0.8ml	75 bd	0.75		syringes	140	150mg/ 1ml	140 bd	0.94
syringes	80	80mg/0.8ml	80 bd	0.80			145	150mg/ 1ml	145 bd	0.98
	85	100mg/ 1ml	85 bd	0.85			150	150mg/ 1ml	150 bd	1.00
	90	100mg/ 1ml	90 bd	0.90
	95	100mg/ 1ml	95 bd	0.95
	100	100mg/ 1ml	100 bd	1.00

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been rounded up to the nearestgraduation.

1)    Treating blood clots that are in your blood

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

♦    Clexane will usually be given for at least 5 days

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

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 askyou 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 using Clexane Multidose Vial or 50, 80 or 100mg Pre-filled syringes)

*    At the same time, you will also be given Clexane as an injection under your skin (subcutaneous injection). The usual dose is 1mg for every kilogram of your weight.

*    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 521281 called Percutaneous Coronary ⁵⁶⁹⁴²³ 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 using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)

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

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

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

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

How to give yourself an injection of Clexane

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

Before injecting yourself with Clexane

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

■    Check the syringe is not damaged and the medicine in it is a clear solution. If not,

use another syringe

3

Dosage chart for 1mg/kg SC treatment of STEMI						Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)		Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
	40	40mg/0.4ml	40 bd	0.40			105	120mg/0.8ml (1)	105 bd (1)	0.70 (1)
	45	60mg/0.6ml	45 bd	0.45			110	120mg/0.8ml (1)	110 bd (1)	0.74 (1)
	50	60mg/0.6ml	50 bd	0.50		150mg/ml	115	120mg/0.8ml (1)	115 bd (1)	0.78 (1)
	55	60mg/0.6ml	55 bd	0.55		Solution for	120	120mg/0.8ml (1)	120 bd (1)	0.80 (1)
100mg/ml	60	60mg/0.6ml	60 bd	0.60		Injection	125	150mg/ 1ml (1)	125 bd (1)	0.84 (1)
Solution for	65	80mg/0.8ml	65 bd	0.65		CLEXANE	130	150mg/ 1ml (1)	130 bd (1)	0.88 (1)
Injection	70	80mg/0.8ml	70 bd	0.70		Forte	135	150mg/ 1ml (1)	135 bd (1)	0.90 (1)
CLEXANE	75	80mg/0.8ml	75 bd	0.75		syringes	140	150mg/ 1ml (1)	140 bd (1)	0.94 (1)
syringes	80	80mg/0.8ml	80 bd	0.80			145	150mg/ 1ml (1)	145 bd (1)	0.98 (1)
	85	100mg/ 1ml	85 bd	0.85			150	150mg/ 1ml (1)	150 bd (1)	1.00 (1)
	90	100mg/ 1ml	90 bd	0.90
	95	100mg/ 1ml	95 bd	0.95
	100	100mg/ 1ml	100 bd	1.00

(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only, followed bylmg/kgdosing for the remaining doses)

Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on tne syringe and so some of the volumes recommended in this table have been rounded up to the nearest graduation.

When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific) enoxaparin sodium should be given between 15 minutes before and 30 minutes after the start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as they are identified as having STEMI and maintained under (75 to 325mg once daily) unless contraindicated.

The recommended duration ofenoxaparin sodium treatment is 8 days or until hospital discharge, whichevercomes 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 of0.3mg/kg ofenoxaparin sodium should be administered.

Prevention ofextracorporeal thrombusformation duringhaemodialvsis:

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 ringsare found, such as aftera longerthan normal session, a furtherdose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients ata 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) Tor single vascular access. Elderlv:

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).

■    Make sure you know how much you are going to inject

■    Check your abdomen to see if the last injection caused any redness, change in skin colour, swelling, oozing or is still painful, if so talk to your doctor or nurse

■    Decide where you are going to inject the medicine. Change the place where you inject each time from the right to the left side of your stomach. Clexane should be injected just under the skin on your stomach, but not too near the belly button or any scar tissue (at least 5 cm away from these)

Instructions on injecting yourself with

Clexane:

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

2)Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place you aregoingto inject. A lounge chair, recliner, or bed

3)    Choose an area on the right or left side of your stomach. This should be at least 5 centimetres away from your belly button and out towards your sides.

Remember: Do not inject yourself within 5 centimetres of your belly button or around existing scars or bruises. Change the place where you inject between the left and right sides of your stomach, depending on the area you were last injected.

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

Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead to a loss of the medicine. Once you have removed the cap, do not allow the needle to touch anything. This is to make sure the needlestays clean (sterile).

5) Hold the syringe in the hand you write with (like a pencil) and with your other hand, gently pinch the cleaned area of your abdomen between your forefinger and thumb to make a fold in the skin

Make sureyou hold the skin fold throughout the injection.

6)    Hold the syringe so that the needle is pointing downwards (vertically at a 90° angle). Insertthefull length oftheneedleinto the skin fold

7)    Press down on the plunger with your finger. This will send the medication into the fatty tissue of the stomach. Make sure you hold the skin fold throughout the injection

8) Remove the needle by pulling it straight out. A protective sleeve will automatically cover the needle. You can now let go of the skin fold.

Dosage chart for 0.75mg/kg SC treatment of STEMI    (elderly patients aged >75 years only)

Patient weight	Kg	Syringe label	0.75mg/kg Dose (mg)	Adjusted dosing (mg)	Injection volume (ml)
100mg/ml Solution for Injection CLEXANE syringes	40 45 50 55 60 65 70 75 80	EEEEEEEEE X' X) X) X) X) X) X) X) X) o o o o o o o o o DO DO DO DO DO DO DO DO DC EEEEEEEEE ooooooooo XT1 CD CD CD CD CD CD CD CD	30 bd 33.75    bd 37.5    bd 41.25    bd 45 bd 48.75    bd 52.5    bd 56.25    bd 60 bd	30 bd 35 bd 37.5    bd 42.5    bd 45 bd 50 bd 52.5    bd 57.5    bd 60 bd	0.30 0.35 0.375 0.425 0.45 0.5 0.525 0.575 0.60
	85 90 95 100 105	E E E E E CO CO CO CO CO o o o o o DO OO OO DO DO E E E E E o o o o o CO CO CO CO CO	63.75 bd 67.5 bd 71.25 bd 75 bd 78.75 bd (1)	65 bd 67.5    bd 72.5    bd 75 bd 80 bd (1)	0.65 0.675 0.725 0.75 0.80 (1)
	110 115 120 125 130	E E E E E DO DO DO DO DC E E E E E o o o o o o o o o o	82.5    bd (1) 86.25 bd (1) 90 bd (1) 93.75 bd (1) 97.5    bd (1)	82.5    bd (1) 87.5    bd (1) 90 bd (1) 95 bd (1) 97.5    bd (1)	0.825(1) 0.875 (1) 0.90(1) 0.95(1) 0.975 (1)
150mg/ml Solution for Injection CLEXANE Forte syringes	135 140 145 150	E E E E cq cq cq cq o o o o DO DO DO DC E E E E o o o o	101.25 bd (1) 105 bd (1) 108.75 bd (1) 112.5 bd (1)	102 bd (1) 105 bd (1) 111 bd (1) 114 bd (1)	0.68 (1) 0.7(1) 0.74 (1) 0.76 (1)

(1) not to be given for the first two doses - (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses) Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe and so some of the volumes recommended in this table have been rounded up to the nearest graduation.

Children: Not recommended, as dosage not established.

Renal impairment: (Seealso section 4.4 Special warningsand precautionsforuse: Renal impairment and Monitoring; section 5.2 Pharmacokinetic properties). Severe renal impairment:

A dosage adjustment is required for patients with severe renal impairment (creatinine clearance < 30 ml/min), according to the following tables, since enoxaparin sodium exposure is significantly increased in this patient population:

Dosage adjustments for therapeutic dosage range

Standard dosing	Severe renal impairment
1 mg/kgSCtwicedaily	1 mg/kg SC once daily
1.5 mg/kg SC once daily	1 mg/kg SC once daily
Fortreatment ofacute STEMI in patients<75years ofage
30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kgtwice daily. (Max 100mgfor each ofthe first two SC doses)	30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg once daily. (Max 100mgforfirst SC dose only)
Fortreatment of acute STEMI in elderly patients >75years of age
0.75mg/kg SCtwicedailywithout initial bolus. (Max 75mgfor each ofthe first two SC doses)	1mg/kg SC once daily without initial bolus. (Max 100mgforfirst SC dose only)

Note: the safety system allowing release of the protective sleeve, can only be activated when the syringe has been emptied by pressing the plungerall theway down.

To avoid bruising, do not rub the injection site after you have injected yourself.

9)Drop the used syringe with its protective sleeve into the sharps bin provided. Close the container lid tightly and place the container out of reach of children.

When the container is full, give it to your doctor or home care nurse for disposal. Do not put it in the household rubbish.

If you have more Clexane than you should

If you think that you have used too much or too little Clexane, tell your doctor, nurse or pharmacist immediately, even if you have no signs of a problem. If a child accidentally injects or swallows Clexane, take them to a hospital casualty department straight away. If you forget to use Clexane Ifyou forget to give yourself a dose, have it as soon as you remember. Do not give yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary will help to make sureyou do not miss a dose If you stop using Clexane It is important foryou to keep having Clexane injections until your doctor decides to stop them. If you stop, you could get a blood clot which can bevery dangerous.

Blood Tests

Using Clexane may affect the results of some blood tests. If you are going to have a blood test, it is important to tell your doctor you are having Clexane.

4. Possible side-effects

Like all medicines, Clexane can cause side-effects, although not everybody gets them. Tell a nurse or doctor or go to hospital straight away if you notice any of the following side-effects:

Very common (affects more than 1 in 10 people)

♦    Bleeding a lot from a wound.

Common (affects 1 to 10 people in a 100)

♦    A painful rash of dark red spots under the skin which do not go away when you put pressure on them. You may also notice pink patches on your skin. These are more likely to appear in the area you have been injected with Clexane.

Uncommon (affects 1 to 10 people in a 1,000)

♦    Sudden severe headache. This could be a sign of bleeding in the brain.

♦    A feeling of tenderness and swelling in your stomach. You may have bleeding inside your stomach.

Rare (affects less than 1 in a 1000 people)

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

Frequency unknown

♦    If you have had a spinal puncture or a spinal anaesthetic and notice tingling, numbness and muscular weakness, particularly in the lower part of your body. Also if you lose control over your bladder or bowel (so you cannot control when you go to the toilet).

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 thatyou have difficulty breathing, tiredness or difficulty exercising, chest pain, numbness, feeling sick or loss of consciousness. This could be due to a blood clot on the heart valve

Frequency unknown

♦    Feelingtired, faint, dizzy, having pale skin. These could be symptoms of anaemia.

♦    You notice yellowing of your skin or eyes and your urine becomes darker in colour. This could be a liver problem. mm

Dosage adjustments for prophylactic dosage ranges

Standard dosing	Severe renal impairment
40 mg SC once dailv	20 mg SC once daily
20 mg SC once daily	20 mg SC once daily

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

Moderate and mild renal impairment:

Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring is advised.

Spinal/epidural anaesthesia:

For patients receiving spinal/epidural anaesthesia see section 4.4 Special warnings and precautions for use: Spinal/epidural anaesthesia.

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

Bodvweight:

No dosage adjustments are recommended in obesity or low body weight (see also section 4.4 Special warnings and precautions for use: Low body weight and Monitoring; section 5.2 Pharmacokinetic properties).

Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for the initial dose of acute STEMI indication and before PCI when needed. It must not be administered by the intramuscular route.

To avoid accidental needle stick after injection, the prefilled syringes are fitted with an automatic safety device Subcutaneous injection technique

The prefilled disposable syringe is ready for immediate use. Clexane should be administered when the patient is lying down by deep subcutaneous injection. The administration should be alternated between the left and right anterolateral or posterolateral abdominal wall. The whole length of the needle should be introduced vertically into a skin fold held between the thumb and index finger. The skin fold should not be released until the injection is complete.

Once the plunger is fully pressed down the safety device is activated automatically. This protects the used needle.

Note: The plunger has to be pressed down all the way for the safety device to be activated.

Do not rub the injection site after administration.

Intravenous (Bolus) Injection Technique (foracute STEMI indication only):

For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes can be used. Enoxaparin sodium should be administered through an intravenous line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with all other drugs, the intravenous access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the intravenous bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% dextrose in water.

•    Initial 30mg bolus

For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60,80 or 100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The 30mgdose can then be directly injected into an injection site in the intravenous line.

•    Additional bolus for PCI when last SC administration was given more than 8 hours before balloon insertion

For patients being managed with Percutaneous Coronary Intervention (PCI), an additional IV bolus of 0.3mg/kg is to be administered if last SC administration was given more than 8 hours before balloon inflation (see section 4.2 Posology and method ot administration: Treatment of acute ST-segment Elevation Myocardial Infarction).

In orderto assure the accuracyofthe small volume to be injected, it is recommended to dilute the drug to 3mg/ml.

To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is recommended to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as follows:

Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60mg enoxaparin sodium prefilled

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

Very common (affects more than 1 in 10 people)

♦    Changes in the results of blood tests done to check how your liver is working. These usually go back to normal after you stop having Clexane.

Rare (affects less than 1 in a 1000 people)

♦    Changes in the potassium levels in your blood. This is more likely to happen in people with kidney problems or diabetes. Your doctor will be able to check this by carrying out a blood test.

Frequency unknown

♦    If Clexane is used for a long period of time (more than 3 months), it may increase the risk of you getting a condition called ‘osteoporosis’. This is when your bones are more likely to break

♦    Headache

♦    Hair loss

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store and dispose of 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.

Do not store above 25⁰C. Do not store in a refrigerator or freezer.

Medicines should not be disposed of via wastewater or household waste. If you are using this medicine at home you will be given a container (a sharps bin) to use for disposal. Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist for disposal. These measures will help to protect the environment.

6. Further Information

What Clexane contains

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

♦    Each 40mg pre-filled syringe contains40mg (4,000 IU anti-Xa activity) of the active substance, enoxaparin sodium in 0.4ml

♦    Each 60mg pre-filled syringe contains 60mg (6,000 IU anti-Xa activity ) of the active substance, enoxaparin sodium in 0.6ml

♦    Each 80mg pre-filled syringe contains 80mg (8,000 IU anti-Xa activity) of the active substance, enoxaparin sodium in 0.8ml

♦    Each 100mg pre-filled syringe 521281 contains 100mg (10,000 IU anti-Xa ⁵⁶⁹⁴²³ activity) of the active substance, enoxaparin sodium in 1ml

♦    The other ingredient is water for injections

What Clexane Pre-filled Syringes looks like and contents of the pack

Clexane is a clear, colourless to pale yellow solution for injection in a Type I glass prefilled syringe fitted with an injection needle, needle cap and an automatic safety device, it is supplied in packs of 2,10 and 20 syringes.

Not all packsizes may be marketed.

Marketing Authorisation Holder and Manufacturer

MarketineAuthorisation Holder Sanofi,

One Onslow Street, Guildford,

Surrey, GU1 4YS, UK Tel: 0845 372 7101

email: uk-medicalinformation@sanofi.com

Manufacturer

Sanofi Winthrop Industrie,

Boulevard Industriel,

76580 Le Trait, Seine Maritime, France.

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 12/2013 ©Sanofi, 1990 - 2013

syringe into the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a ⁵²¹²⁸¹ syringe for administration into the intravenous line (usingan appropriate injection site or port).    ⁵⁶⁹⁴²³

Alter dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (ml) = Patientweight(kg)x0.1j or using the table below. Itisrecommended to prepare the dilution immediately before useand to discard any remaining solution immediatelyafter use.

Volume to be injected through intravenous line after dilution is completed

Weight	Required dose (0.3mg/kg)	Volume to inject when diluted to a final concentration of 3mg/ml	Weight	Required dose (0.3mg/kg)	Volume to inject when diluted to a final concentration of 3mg/ml
(Kg)	(mg)	(ml)	(Kg)	(mg)	(ml)
45	13.5	4.5	100	30	10
50	15	5	105	31.5	10.5
55	16.5	5.5	110	33	11
60	18	6	115	34.5	11.5
65	19.5	6.5	120	36	12
70	21	7	125	37.5	12.5
75	22.5	7.5	130	39	13
80	24	8	135	40.5	13.5
85	25.5	8.5	140	42	14
90	27		145	43.5	14.5
95	28.5	9.5	150	45	15

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Waterfor Injections

6.2    Incompatibilities Subcutaneous Injection

Clexane should not be mixed with anyother 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% in dextrose in water.

6.3    Shelf life

36 months

6.4    Special precautions for storage

Do not store above 25°C. Do not refrigerate or freeze.

Clexane pre-filled syringes are single dose containers - discard any unused product

6.5    Nature and contents of container

Solution for injection in Type I glass pre-filled syringes fitted with injection needle and an automatic safety device in packs of2,10 and 20.

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: 22 October 1990 Date of latest renewal: 8 August 2002

10    DATE OF REVISION OF THE TEXT

10/2014

6