CLEXANE 40 MG / 0.4 ML SYRINGES - patient leaflet, side effects, dosage

Patient leaflet - CLEXANE 40 MG / 0.4 ML SYRINGES

1. What Clexane is and what it is used for

2. Before you use Clexane

3. How to use Clexane

4. Possible side-effects

5. How to store Clexane

6. Further information

1. what clexane is and what it is used for

Clexane contains a medicine called enoxaparin sodium. This belongs to a group of medicines called Low Molecular Weight Heparins.

Clexane works in two ways.

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

Clexane can be used to:

Treat blood clots that are in your blood
Stop blood clots forming in your blood in the following situations:
Unstable angina (where not enough blood gets to your heart)
After an operation or long periods of bed rest due to illness
After you have had a heart attack
Stop blood clots forming in the tubes of your dialysis machine (used for people with kidney problems)

2. before you use clexane

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

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

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

You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin or dalteparin
You have a problem with bruising or bleeding too easily
You have an ulcer in your stomach or gut (intestine)
You have had a stroke caused by bleeding in the brain
You have an infection in your heart
You are using 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.

Take special care with Clexane

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

You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your eyes or brain
You are a diabetic or have an illness known as ‘diabetic retinopathy’ (problems with the blood vessels in the eye caused by diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and especially if you are aged over 75 years old

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or nurse before 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:

You 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 or take regular blood tests to check that taking these medicines with Clexane is not causing you any harm.

Operations and anaesthetics

If you are going to have a spinal puncture or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are 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 breastfeeding.

3. how to use clexane

if clexane is used for a long period of time, it may increase the risk of you getting a condition called ‘osteoporosis’. this is when your bones are more likely to break.

5. how to store and dispose of clexane

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

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

The expiry date can be found on the syringe blister container and on the box. It is given as “EXP” followed by the month and year. Clexane should not be used after the end of that month. If you are not sure when this is check with your doctor, pharmacist or nurse.

If your doctor tells you to stop taking the medicine, please take them back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

If the medicine becomes discoloured or shows any signs of deterioration, you should seek the advice of your pharmacist.

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

The active ingredient in Clexane is enoxaparin sodium.

Each syringe contains 40mg enoxaparin sodium in water for injections as the active ingredient.

What Clexane looks like and the contents of the pack

Clexane comes in prefilled syringes which are packed in boxes of 10.

Manufacturer:

Manufactured by: Sanofi-Aventis, S.A., Avda de Leganes No 62, 28925 Alcorcon, Madrid, Spain.

Sanofi Winthrop Industrie, Boulevard Industriel, Zone Industrielle (Le Trait), 76580 France.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL No: 21828/0257 POM

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.

Leaflet revision date: 03.05.13

Clexane® is a registered trademark of May & Baker Limited.

If you stop using Clexane

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

Blood Tests

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

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Clexane can cause side-effects, although not everybody gets them.

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

Tell a nurse or doctor as soon as possible if you notice any of the following side-effects:

Common (affects 1 to 10 people in a 100)

You bruise more easily than usual. This could be because of a blood problem (thrombocytopenia).
You have pain, swelling or irritation in the area you have been injected with Clexane. This normally gets better after a few days.

Rare (affects less than 1 in a 1000 people)

If you have a mechanical heart valve, treatment with Clexane might not be sufficient to prevent blood clots. You may notice that you have difficulty breathing, tiredness or difficulty exercising, chest pain, numbness, feeling sick or loss of consciousness. This could be due to a blood clot on the heart valve.

Clexane ® 40mg/0.4ml Syringes (enoxaparin sodium)

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY

The following information is extracted from the SPC

Technical information for the administration of Clexane Syringes

1. NAME OF THE MEDICINAL PRODUCT

Clexane® 40mg/0.4ml Syringes

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Pre-filled syringes:

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

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

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

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

100mg Injection Enoxaparin sodium 100mg (equivalent to 10,000 IU anti-Xa activity) in 1.0ml Water for Injections

For full list of excipients, see section 6

3. PHARMACEUTICAL FORM

Solution for injection.

4. CLINICAL PARTICULARS

4.2 Posology and method of administration

Adults:

Prophylaxis of venous thromboembolism:

In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20mg (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 40mg (4,000 IU) daily by subcutaneous injection with the initial dose administered approximately 12 hours before surgery.

Prophylaxis of venous thromboembolism in medical patients:

The recommended dose of enoxaparin sodium is 40mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.

Treatment of venous thromboembolism:

Clexane should be administered subcutaneously as a single daily injection of 1.5mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is established.

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both

Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
100mg/ml	40	60mg / 0.6ml	60 od	0.60
100mg/ml	45	80mg / 0.8ml	67.5 od	0.675
Solution for Injection CLEXANE	50	80mg / 0.8ml	75 od	0.75
Solution for Injection CLEXANE	55 60	100mg / 1ml 100mg / 1ml	82.5 od 90 od	0.825 0.90
syringes	65	100mg / 1ml	97.5 od	0.975

Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
	70	120mg / 0.8ml	105 od	0.70
150mg/ml	75	120mg / 0.8ml	112.5 od	0.76
Solution for	80	120mg / 0.8ml	120 od	0.80
Injection	85	150mg / 1ml	127.5 od	0.86
CLEXANE	90	150mg / 1ml	135 od	0.90
syringes	95	150mg / 1ml	142.5 od	0.96
	100	150mg / 1ml	150 od	1.00

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

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

The recommended dose is 1mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325mg once daily).

Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days.

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
	40	40mg / 0.4ml	40 bd	0.40
	45	60mg / 0.6ml	45 bd	0.45
	50	60mg / 0.6ml	50 bd	0.50
100mg/ml	55	60mg / 0.6ml	55 bd	0.55
Solution for	60	60mg / 0.6ml	60 bd	0.60
Injection	65	80mg / 0.8ml	65 bd	0.65
CLEXANE	70	80mg / 0.8ml	70 bd	0.70
syringes	75	80mg / 0.8ml	75 bd	0.75
	80	80mg / 0.8ml	80 bd	0.80
	85	100mg / 1ml	85 bd	0.85
	90	100mg / 1ml	90 bd	0.90
	95	100mg / 1ml	95 bd	0.95
	100	100mg / 1ml	100 bd	1.00

Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
	105	120mg / 0.8ml	105 bd	0.70
	110	120mg / 0.8ml	110 bd	0.74
150mg/ml	115	120mg / 0.8ml	115 bd	0.78
Solution for	120	120mg / 0.8ml	120 bd	0.80
Injection	125	150mg / 1ml	125 bd	0.84
CLEXANE	130	150mg / 1ml	130 bd	0.88
syringes	135	150mg / 1ml	135 bd	0.90
	140	150mg / 1ml	140 bd	0.94
	145	150mg / 1ml	145 bd	0.98
	150	150mg / 1ml	150 bd	1.00

Treatment of acute ST-segment Elevation Myocardial Infarction

The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients >75 years of age, see section 4.2 Posology and method of administration: Elderly.

Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
	40	40mg / 0.4ml	40 bd	0.40
	45	60mg / 0.6ml	45 bd	0.45
	50	60mg / 0.6ml	50 bd	0.50
100mg/ml	55	60mg / 0.6ml	55 bd	0.55
Solution for	60	60mg / 0.6ml	60 bd	0.60
Injection	65	80mg / 0.8ml	65 bd	0.65
CLEXANE	70	80mg / 0.8ml	70 bd	0.70
syringes	75	80mg / 0.8ml	75 bd	0.75
	80	80mg / 0.8ml	80 bd	0.80
	85	100mg / 1ml	85 bd	0.85
	90	100mg / 1ml	90 bd	0.90
	95	100mg / 1ml	95 bd	0.95
	100	100mg / 1ml	100 bd	1.00

Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight	Kg	Syringe label	Dose (mg)	Injection volume (ml)
	105	120mg / 0.8ml (1)	105 bd (1)	0.70 (1)
	110	120mg / 0.8ml (1)	110 bd (1)	0.74 (1)
150mg/ml	115	120mg / 0.8ml (1)	115 bd (1)	0.78 (1)
Solution for	120	120mg / 0.8ml (1)	120 bd (1)	0.80 (1)
Injection	125	150mg / 1ml (1)	125 bd (1)	0.84 (1)
CLEXANE	130	150mg / 1ml (1)	130 bd (1)	0.88 (1)
syringes	135	150mg / 1ml (1)	135 bd (1)	0.90 (1)
	140	150mg / 1ml (1)	140 bd (1)	0.94 (1)
	145	150mg / 1ml (1)	145 bd (1)	0.98 (1)
	150	150mg / 1ml (1)	150 bd (1)	1.00 (1)

(1) Not to be given for the first two doses – (maximum 100mg for the first two doses only, followed by 1mg/kg dosing for the remaining doses)

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

The recommended duration of enoxaparin sodium treatment is 8 days or until hospital discharge, whichever comes first.

For patients managed with Percutaneous Coronary Intervention (PCI): If the last enoxaparin sodium SC administration was given less than 8 hours before balloon inflation, no additional dosing is needed. If the last SC administration was given more than 8 hours before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin sodium should be administered.

Prevention of extracorporeal thrombus formation during haemodialysis:

A dose equivalent to 1mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5mg/kg (50 IU/kg) for double vascular access or 0.75mg/kg (75 IU/kg) for single vascular access.

Elderly:

For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients >75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses).

For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is impaired (see also section 4.2 Posology and method of administration: Renal impairment ; section 4.4 Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment, and Monitoring; section 5.2 Pharmacokinetic properties).

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

Patient weight	Kg	Syringe label	0.75mg/kg Dose (mg)	Adjusted dosing (mg)	Injection volume (ml)
	40	60mg / 0.6ml	30 bd	30 bd	0.30
	45	60mg / 0.6ml	33.75 bd	35 bd	0.35
	50	60mg / 0.6ml	37.5 bd	37.5 bd	0.375
	55	60mg / 0.6ml	41.25 bd	42.5 bd	0.425
	60	60mg / 0.6ml	45 bd	45 bd	0.45
	65	60mg / 0.6ml	48.75 bd	50 bd	0.5
	70	60mg / 0.6ml	52.5 bd	52.5 bd	0.525
100mg/ml	75	60mg / 0.6ml	56.25 bd	57.5 bd	0.575
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	90	80mg / 0.8ml	67.5 bd	67.5 bd	0.675
syringes	95	80mg / 0.8ml	71.25 bd	72.5 bd	0.725
	100	80mg / 0.8ml	75 bd	75 bd	0.75
	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)
	115	100mg / 1ml	86.25 bd (1)	87.5 bd (1)	0.875 (1)
	120	100mg / 1ml	90 bd (1)	90 bd (1)	0.90 (1)
	125	100mg / 1ml	93.75 bd (1)	95 bd (1)	0.95 (1)
	130	100mg / 1ml	97.5 bd (1)	97.5 bd (1)	0.975 (1)
150mg/ml	135	120mg / 0.8ml	101.25 bd (1)	102 bd (1)	0.68 (1)
Solution for	140	120mg / 0.8ml	105 bd (1)	105 bd (1)	0.7 (1)
Injection	145	120mg / 0.8ml	108.75 bd (1)	111 bd (1)	0.74 (1)
CLEXANE Forte syringes	150	120mg / 0.8ml	112.5 bd (1)	114 bd (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).

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 < 30ml/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
1mg/kg SC twice daily	1mg/kg SC once daily
1.5mg/kg SC once daily	1mg/kg SC once daily
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg twice daily. (Max 100mg for each of the first two SC doses)	30mg-single IV bolus plus a 1mg/kg SC dose followed by 1mg/kg once daily. (Max 100mg for first SC dose only)
For treatment of acute STEMI in elderly patients >75 years of age
0.75mg/kg SC twice daily without initial bolus. (Max 75mg for each of the first two SC doses)	1mg/kg SC once daily without initial bolus. (Max 100mg for first SC dose only)

Dosage adjustments for prophylactic dosage ranges

Standard dosing	Severe renal impairment
40mg SC once daily	20mg SC once daily
20mg SC once daily	20mg 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 30–50ml/min) or mild renal impairment (creatinine clearance 50–80ml/min), careful clinical monitoring is advised.

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

Body weight:

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

Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic disease, treatment of deep vein thrombosis or for the treatment of unstable angina, non-Q-wave myocardial infarction and acute ST elevation myocardial infarction (STEMI); through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extra-corporeal circulation during haemodialysis; and via intravenous (bolus) injection through an intravenous line only for the initial dose of acute 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 (for acute STEMI indication only):

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

Initial 30mg bolus

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

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

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

In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 3mg/ml.

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

Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml remaining in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted solution with a syringe for administration into the intravenous line (using an appropriate injection site or port).

After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is recommended to prepare the dilution immediately before use and to discard any remaining solution immediately after use.

Volume to be injected through intravenous line after dilution is completed

Weight	Required dose (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	9	145	43.5	14.5
95	28.5	9.5	150	45	15

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for injections.

6.2 Incompatibilities

Subcutaneous Injection

Clexane should not be mixed with any other injections or infusions.

Intravenous (Bolus) Injection for acute STEMI indication only

Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in dextrose in water.

6.3 Shelf life

36 months

6.4 Special precautions for storage