CLEXANE FORTE SYRINGES
Active substance: ENOXAPARIN SODIUM
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PACKAGE LEAFLET: INFORMATION FOR THE USER
1. What Clexane Forte is and what it is used for
The name of your medicine is Clexane Forte 120mg or 150mg Pre-filled Syringes (called Clexane Forte in this leaflet). Clexane Forte contains a medicine called enoxaparin sodium. This belongs to a group of medicines called Low Molecular Weight Heparins. Clexane Forte 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 Forte 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 Forte Do not have this medicine and tell your doctor if:
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side-effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. In this leaflet: 1. hat Clexane Forte is and what it is used for W 2. efore you use Clexane Forte B 3. ow to use Clexane Forte H 4. ossible side-effects P 5. ow to store and dispose of Clexane Forte H 6. urther information F
You are allergic (hypersensitive) 519350 to enoxaparin sodium. Signs of 456732 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 are bleeding heavily 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 take this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Clexane Forte. Take special care with Clexane Forte Check with your doctor or pharmacist before having this medicine if: You have high blood pressure which is not controlled by medication 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
1 519350 456732
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
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NAME OF THE MEDICINAL PRODUCT QUALITATIVE AND QUANTITATIVE COMPOSITION
Clexane Forte Syringes
Pre-filled syringes: 120 mg InjectionE noxaparin sodium 120 mg (equivalent to 12,000 IU anti-Xa activity) in 0.8 mL Water for Injections 150 mg InjectionE noxaparin sodium 150 mg (equivalent to 15,000 IU anti-Xa activity) in 1.0 mL Water for Injections For full list of excipients, see section 6.1
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PHARMACEUTICAL FORM
Solution for injection. Clear, colourless to pale yellow solution. 4.2 Posology and method of administration Adults: Prophylaxis of venous thromboembolism: In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose administered approximately 12 hours before surgery. Prophylaxis of venous thromboembolism in medical patients: The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days. Treatment of venous thromboembolism: Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is established. 1
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
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, pharmacist or nurse before having Clexane Forte.
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 Forte can affect the way some other medicines work. Also some medicines can affect the way Clexane Forte works. In particular, do not take 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 - used to stop blood clots from forming. Aspirin may also be used for pain relief and in medicines for colds and flu
Dipyridamole, clopidogrel, or other medicines - used to stop blood clots forming Streptokinase, alteplase and reteplase - used to dissolve blood clots after a heart attack Dextran injection - used to replace blood volume Ibuprofen, diclofenac, ketorolac or other medicines used to treat pain and swelling in arthritis and other illnesses Prednisolone, dexamethasone or other steroid 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 Forte Your doctor may change one of your medicines or take regular blood tests to check that taking these medicines with Clexane Forte 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 Forte. Tell also your doctor if you have any problem with your spine or if you have ever had spinal surgery. Pregnancy and breast-feeding Talk to your doctor before you are given this medicine if you are pregnant, might become pregnant or think you may be
pregnant. You should not use this medicine if you are pregnant and have a mechanical heart valve as you may be at increased risk of developing blood clots. Your doctor should discuss this with you. You should not breast-feed whilst using Clexane Forte. If you are planning to breastfeed, talk to your doctor, pharmacist or nurse. Ask your doctor, pharmacist or nurse for advice before taking any medicine if you are pregnant or breast-feeding. 3. How to use Clexane Forte Having this medicine Before you have Clexane Forte your doctor or nurse may carry out a blood test While you are in hospital your doctor or nurse will normally give you Clexane Forte. This is because it needs to be given as an injection When you go home you may need to continue to use Clexane Forte and give it to yourself (see below instructions on how to do this) Clexane Forte is usually given by injection underneath the skin (subcutaneous) If you are not sure why you are receiving Clexane Forte or have any questions about how much Clexane Forte is being given to you, speak to your doctor, pharmacist or nurse.
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both Patient Injection Kg Syringe label Dose (mg) weight volume (ml) 100mg/ml Solution for Injection CLEXANE syringes
40 45 50 55 60 65 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 60 od 67.5 od 75 od 82.5 od 90 od 97.5 od 0.60 0.675 0.75 0.825 0.90 0.975
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Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both Patient Injection Kg Syringe label Dose (mg) weight volume (ml) 150mg/ml Solution for Injection CLEXANE syringes
70 75 80 85 90 95 100 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 105 od 112.5 od 120 od 127.5 od 135 od 142.5 od 150 od 0.70 0.76 0.80 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-Q-wave myocardial infarction The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days. Dosage chart for 1mg/kg SC treatment of UA or NSTEMI Patient Injection Kg Syringe label Dose (mg) weight volume (ml)
40 45 50 55 60 65 70 75 80 85 90 95 100 40mg / 0.4ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 40 bd 45 bd 50 bd 55 bd 60 bd 65 bd 70 bd 75 bd 80 bd 85 bd 90 bd 95 bd 100 bd 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI Patient Injection Kg Syringe label Dose (mg) weight volume (ml)
105 110 115 120 125 130 135 140 145 150 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 105 bd 110 bd 115 bd 120 bd 125 bd 130 bd 135 bd 140 bd 145 bd 150 bd 0.70 0.74 0.78 0.80 0.84 0.88 0.90 0.94 0.98 1.00
100mg/ml Solution for Injection CLEXANE syringes
150mg/ml Solution for Injection CLEXANE syringes
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. 2
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
How much will be given to you in hospital Your doctor will decide how much to give you. The amount of Clexane Forte 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 Forte Adults including the elderly 1)Treating blood clots that are in your blood The usual dose is 1.5mg for every kilogram of your weight, each day Clexane Forte 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 dose is 1mg for every kilogram of your weight, every 12 hours Clexane Forte will usually be given for 2 to 8 days. Your doctor will normally ask you to take aspirin as well b) After an operation or long periods of bed rest 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 Forte each day for 7 to 10 days. If you are going to have an operation, your first
injection will usually be given 2 hours before your operation If you have a higher risk of getting a clot, you will be given 40mg each day for 7 to 10 days. If you are going to have an operation, your first injection will usually be given 12 hours before your operation If you are bedridden due to illness, you will be normally be given 40mg of Clexane Forte 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) TEMI type of heart attack S 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 60, 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 519350 for every kilogram of your 456732 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 Forte under your skin (subcutaneous injection) The usual dose is 0.75mg for every kilogram of your weight, every 12 hours The maximum amount of Clexane given for the first two injections is 75mg For patients having an operation called Percutaneous Coronary Intervention (PCI) Depending on when you were last given Clexane Forte, 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 1mg for every kilogram of your weight Clexane Forte is added to the tube leaving the body (arterial line) at the start of the dialysis session
3 519350 Treatment of acute ST-segment Elevation Myocardial Infarction 456732 The recommended dose of enoxaparin sodium is a single IV bolus of 30mg (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes) 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.
Patient weight
Dosage chart for 1mg/kg SC treatment of STEMI Injection Kg Syringe label Dose (mg) volume (ml)
40 45 50 55 60 65 70 75 80 85 90 95 100 40mg / 0.4ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 40 bd 45 bd 50 bd 55 bd 60 bd 65 bd 70 bd 75 bd 80 bd 85 bd 90 bd 95 bd 100 bd 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00
Patient weight
Dosage chart for 1mg/kg SC treatment of STEMI Injection Kg Syringe label Dose (mg) volume (ml)
105 110 115 120 125 130 135 140 145 150 120mg / 0.8ml (1) 120mg / 0.8ml (1) 120mg / 0.8ml (1) 120mg / 0.8ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 105 bd (1) 110 bd (1) 115 bd (1) 120 bd (1) 125 bd (1) 130 bd (1) 135 bd (1) 140 bd (1) 145 bd (1) 150 bd (1) 0.70 (1) 0.74 (1) 0.78 (1) 0.80 (1) 0.84 (1) 0.88 (1) 0.90 (1) 0.94 (1) 0.98 (1) 1.00 (1)
100mg/ml Solution for Injection CLEXANE syringes
100mg/ml Solution for Injection CLEXANE syringes
(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) 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. 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 (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes). Prevention of extracorporeal thrombus formation during haemodialysis: A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1 mg/kg (50 to 100 IU/kg) may be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular access. Elderly: For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients 75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses). For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is impaired (see also section 4.2 Posology and method of administration: Renal impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment and Monitoring; section 5.2 Pharmacokinetic properties). 3
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
This amount is usually enough for a belly button or any scar tissue (at least 4 hour session. However, your doctor 5cm away from these) may give you a further dose of 0.5 to 1mg for every kilogram of your weight Instructions on injecting yourself with Clexane Forte: if necessary Children 1)Wash your hands and the area that you This medicine should not be given to will inject with soap and water. Dry children. them. How to give yourself an injection of Clexane Forte If you are able to give Clexane Forte to yourself, your doctor or nurse will show you how to 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. 2)Sit or lie in a comfortable position so you Before injecting yourself with Clexane are relaxed. Make sure you can see the Forte place you are going to inject. A lounge Check the expiry date on the medicine. chair, recliner, or bed propped up with Do not use if the date has passed pillows is ideal. Check the syringe is not damaged and the medicine in it is a clear solution. If not, use another syringe Make sure you know how much you are going to inject Check your abdomen to see if the last injection caused any redness, change 3)Choose an area on the right or left side in skin colour, swelling, oozing or is still of your stomach. This should be at least painful. If so talk to your doctor or nurse 5 centimetres away from your belly Decide where you are going to inject the button and out towards your sides. medicine. Change the place where you Remember: Do not inject yourself inject each time from the right to the within 5cm of your belly button or left side of your stomach. Clexane Forte around existing scars or bruises. Change should be injected just under the skin the place where you inject between the on your stomach, but not too near 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 Forte 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 needle stays 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 sure you hold the skin fold throughout the injection.
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Dosage chart for 0.75mg/kg SC treatment of STEMI (elderly patients aged 75 years only) Patient weight Kg
40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 135 140 145 150
Syringe label
60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml
0.75mg/kg Dose (mg)
30 bd 33.75 bd 37.5 bd 41.25 bd 45 bd 48.75 bd 52.5 bd 56.25 bd 60 bd 63.75 bd 67.5 bd 71.25 bd 75 bd 78.75 bd (1) 82.5 bd (1) 86.25 bd (1) 90 bd (1) 93.75 bd (1) 97.5 bd (1) 101.25 bd (1) 105 bd (1) 108.75 bd (1) 112.5 bd (1)
Adjusted dosing (mg)
30 bd 35 bd 37.5 bd 42.5 bd 45 bd 50 bd 52.5 bd 57.5 bd 60 bd 65 bd 67.5 bd 72.5 bd 75 bd 80 bd (1) 82.5 bd (1) 87.5 bd (1) 90 bd (1) 95 bd (1) 97.5 bd (1) 102 bd (1) 105 bd (1) 111 bd (1) 114 bd (1)
Injection volume (ml)
0.30 0.35 0.375 0.425 0.45 0.5 0.525 0.575 0.60 0.65 0.675 0.725 0.75 0.80 (1) 0.825 (1) 0.875 (1) 0.90 (1) 0.95 (1) 0.975 (1) 0.68 (1) 0.7 (1) 0.74 (1) 0.76 (1)
100mg/ml Solution for Injection CLEXANE syringes
150mg/ml Solution for Injection CLEXANE Forte syringes
(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: (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: Standard dosing
1 mg/kg SC twice daily 1.5 mg/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)
Dosage adjustments for therapeutic dosage range Severe renal impairment
1 mg/kg SC once daily 1 mg/kg SC once daily
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)
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Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
6)Hold the syringe so that the needle 9)Drop the used syringe with its protective 4. Possible side effects is pointing downwards (vertically at a sleeve into the sharps bin provided. Close 90 angle). Insert the full length of the the container lid tightly and place the Like all medicines, Clexane Forte can cause side-effects, although not everybody gets needle into the skin fold. container out of reach of children. them. 7)Press down on the plunger with your When the container is full, give it to finger. This will send the medication into your doctor or home care nurse for Tell a nurse or doctor or go to hospital the fatty tissue of the stomach. Make disposal. Do not put it in the household straight away if you notice any of the following side-effects: sure you hold the skin fold throughout rubbish. the injection. If you have too much or too little Very common (affects more than 1 in 10 people) Clexane Forte If you think that you have used too much Bleeding a lot from a wound. or too little Clexane Forte, tell your doctor, Common (affects 1 to 10 people in a 100) nurse or pharmacist immediately, even if A painful rash of dark red spots under the you have no signs of a problem. If a child skin which do not go away when you put accidentally injects or swallows Clexane pressure on them. You may also notice Forte, take them to a hospital casualty pink patches on your skin. These are department straight away. more likely to appear in the area you 8)Remove the needle by pulling it straight have been injected with Clexane Forte. out. A protective sleeve will automatically If you forget to use Clexane Forte Uncommon (affects 1 to 10 people in a cover the needle. You can now let go of If you forget to give yourself a dose, have it as soon as you remember. Do not give 1,000) the skin fold. yourself a double dose on the same day Sudden severe headache. This could be a sign of bleeding in the brain. to make up for a forgotten dose. Keeping a diary will help to make sure you do not A feeling of tenderness and swelling in your stomach. You may have bleeding miss a dose. inside your stomach. If you stop using Clexane Forte Rare (affects less than 1 in a 1000 people) It is important for you to keep having Clexane Forte injections until your doctor If you have an allergic reaction. The signs may include: a rash, swallowing decides to stop them. If you stop, you or breathing problems, swelling of your Note: the safety system allowing release could get a blood clot which can be very lips, face, throat or tongue. of the protective sleeve can only be dangerous. If you have had a spinal puncture or a activated when the syringe has been spinal anaesthetic and notice tingling, emptied by pressing the plunger all the Blood Tests Using Clexane Forte may affect the results numbness and muscular weakness, way down. of some blood tests. If you are going to particularly in the lower part of your To avoid bruising, do not rub the have a blood test, it is important to tell body. Also if you lose control over your injection site after you have injected your doctor you are having Clexane Forte. yourself.
Dosage adjustments for prophylactic dosage ranges Standard dosing
40 mg SC once daily 20 mg SC once daily
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Severe renal impairment
20 mg SC once daily 20 mg SC once daily
The recommended dosage adjustments do not apply to the haemodialysis indication. *The Clexane 100mg/ml Multidose Vial or Clexane 60mg, 80mg or 100mg pre-filled syringes should be used to administer the IV dose. Moderate and mild renal impairment: Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring is advised. Hepatic impairment: In the absence of clinical studies, caution should be exercised. Body weight: No dosage adjustments are recommended in obesity or low body weight (see also section 4.4 Special warnings and precautions for use: Low body weight and Monitoring; section 5.2 Pharmacokinetic properties). Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic disease, 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 (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes). 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). 5
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
Your doctor will be able to check this by Each 150mg pre-filled syringe 519350 carrying out a blood test. contains 150mg (15,000 IU 456732 anti-Xa activity) of the active Tell a nurse or doctor as soon as possible Frequency unknown substance, enoxaparin sodium in 1.0ml if you notice any of the following side If Clexane Forte is used for a long period of time, it may increase the risk of you The other ingredient is water for effects: getting a condition called osteoporosis. injections Common (affects 1 to 10 people in a 100) This is when your bones are more likely You bruise more easily than usual. This What Clexane Forte looks like and to break. could be because of a blood problem contents of the pack (thrombocytopenia). Clexane Forte is a clear solution in a 5. How to store and dispose of Clexane Forte You have pain, swelling or irritation in Type I glass pre-filled syringe fitted with the area you have been injected with Keep this medicine in a safe place where an injection needle and needle cap. It is Clexane Forte. This normally gets better children cannot see or reach it. supplied in packs of 2, 10 and 20 syringes. after a few days. Do not use Clexane Forte after the expiry Not all pack sizes may be marketed. Rare (affects less than 1 in a 1000 people) date which is stated on the syringe label Marketing Authorisation If you have a mechanical heart valve, and on the box. The expiry date refers to Holder and Manufacturer treatment with Clexane Forte might the last day of that month. not be sufficient to prevent blood clots. Store below 25C. Do not store in a Marketing Authorisation Holder You may notice that you have difficulty refrigerator or freezer. Store in the original Sanofi, breathing, tiredness or difficulty container. One Onslow Street, Guildford, exercising, chest pain, numbness, feeling Medicines should not be disposed of via Surrey, GU1 4YS, UK sick or loss of consciousness. This could wastewater or household waste. If you are Tel: 01483 505515 - Fax: 01483 535432 be due to a blood clot on the heart valve using this medicine at home you will be email: Other side effects that you should given a container (a sharps bin) to use for uk-medicalinformation@sanofi.com discuss with your nurse or doctor if you disposal. Return the sharps bin or any used Manufacturer are concerned about them: or unused syringes to your doctor or nurse Very common (affects more than 1 in 10 or pharmacist for disposal. These measures Sanofi Winthrop Industrie, 180 Rue Jean Jaures, people) will help to protect the environment. B.P. 37, Changes in the results of blood tests done 94702 Maisons-Alfort Cedex, France. 6. Further information to check how your liver is working. These This leaflet does not contain all the usually go back to normal after you stop What Clexane Forte contains information about your medicine. If you having Clexane Forte. Rare (affects less than 1 in a 1000 people) Each 120mg pre-filled syringe contains have any questions or are not sure about 120mg (12,000 IU anti-Xa activity) of the anything, ask your doctor or pharmacist. Changes in the potassium levels in your active substance, enoxaparin sodium in This leaflet was last revised in 04/2012. blood. This is more likely to happen in 0.8ml people with kidney problems or diabetes. sanofi, 2012
6 519350 After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution 456732 (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
bladder or bowel (so you cannot control when you go to the toilet).
Weight
(Kg) 45 50 55 60 65 70 75 80 85 90 95
Required dose (0.3mg/kg)
(mg) 13.5 15 16.5 18 19.5 21 22.5 24 25.5 27 28.5
Volume to inject when diluted to a final concentration of 3mg/ml
(ml) 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5
Weight
(Kg) 100 105 110 115 120 125 130
Required dose (0.3mg/kg)
(mg) 30 31.5 33 34.5 36 37.5 39 40.5
Volume to inject when diluted to a final concentration of 3mg/ml
(ml) 10 10.5 11 11.5 12 12.5 13 13.5
135 140 145 150
42 43.5 45
14 14.5 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% dextrose in water. 6.3 Shelf life 24 months. 6.4 Special precautions for storage Do not store above 25C. Do not refrigerate or freeze. Clexane prefilled syringes are single dose containers - discard any unused product. 6.5 Nature and contents of container Solution for injection in Type I glass prefilled syringes fitted with injection needle and an automatic safety device in packs of 2, 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: 16 December 1999 Date of latest renewal: 4 February 2009 10 DATE OF REVISION OF THE TEXT 10/2011 6
1. What Clexane Forte is and what it is used for
The name of your medicine is Clexane Forte 120mg or 150mg Pre-filled Syringes (called Clexane Forte in this leaflet). Clexane Forte contains a medicine called enoxaparin sodium. This belongs to a group of medicines called Low Molecular Weight Heparins. Clexane Forte 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 Forte 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 Forte Do not have this medicine and tell your doctor if:
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start using this medicine Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side-effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse. In this leaflet: 1. hat Clexane Forte is and what it is used for W 2. efore you use Clexane Forte B 3. ow to use Clexane Forte H 4. ossible side-effects P 5. ow to store and dispose of Clexane Forte H 6. urther information F
You are allergic (hypersensitive) 519350 to enoxaparin sodium. Signs of 456732 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 are bleeding heavily 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 take this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Clexane Forte. Take special care with Clexane Forte Check with your doctor or pharmacist before having this medicine if: You have high blood pressure which is not controlled by medication 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
1 519350 456732
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 2
NAME OF THE MEDICINAL PRODUCT QUALITATIVE AND QUANTITATIVE COMPOSITION
Clexane Forte Syringes
Pre-filled syringes: 120 mg InjectionE noxaparin sodium 120 mg (equivalent to 12,000 IU anti-Xa activity) in 0.8 mL Water for Injections 150 mg InjectionE noxaparin sodium 150 mg (equivalent to 15,000 IU anti-Xa activity) in 1.0 mL Water for Injections For full list of 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 of venous thromboembolism: In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous injection with the initial dose administered approximately 12 hours before surgery. Prophylaxis of venous thromboembolism in medical patients: The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days. Treatment of venous thromboembolism: Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg (150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until adequate oral anticoagulation is established. 1
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
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, pharmacist or nurse before having Clexane Forte.
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 Forte can affect the way some other medicines work. Also some medicines can affect the way Clexane Forte works. In particular, do not take 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 - used to stop blood clots from forming. Aspirin may also be used for pain relief and in medicines for colds and flu
Dipyridamole, clopidogrel, or other medicines - used to stop blood clots forming Streptokinase, alteplase and reteplase - used to dissolve blood clots after a heart attack Dextran injection - used to replace blood volume Ibuprofen, diclofenac, ketorolac or other medicines used to treat pain and swelling in arthritis and other illnesses Prednisolone, dexamethasone or other steroid 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 Forte Your doctor may change one of your medicines or take regular blood tests to check that taking these medicines with Clexane Forte 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 Forte. Tell also your doctor if you have any problem with your spine or if you have ever had spinal surgery. Pregnancy and breast-feeding Talk to your doctor before you are given this medicine if you are pregnant, might become pregnant or think you may be
pregnant. You should not use this medicine if you are pregnant and have a mechanical heart valve as you may be at increased risk of developing blood clots. Your doctor should discuss this with you. You should not breast-feed whilst using Clexane Forte. If you are planning to breastfeed, talk to your doctor, pharmacist or nurse. Ask your doctor, pharmacist or nurse for advice before taking any medicine if you are pregnant or breast-feeding. 3. How to use Clexane Forte Having this medicine Before you have Clexane Forte your doctor or nurse may carry out a blood test While you are in hospital your doctor or nurse will normally give you Clexane Forte. This is because it needs to be given as an injection When you go home you may need to continue to use Clexane Forte and give it to yourself (see below instructions on how to do this) Clexane Forte is usually given by injection underneath the skin (subcutaneous) If you are not sure why you are receiving Clexane Forte or have any questions about how much Clexane Forte is being given to you, speak to your doctor, pharmacist or nurse.
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both Patient Injection Kg Syringe label Dose (mg) weight volume (ml) 100mg/ml Solution for Injection CLEXANE syringes
40 45 50 55 60 65 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 60 od 67.5 od 75 od 82.5 od 90 od 97.5 od 0.60 0.675 0.75 0.825 0.90 0.975
2
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both Patient Injection Kg Syringe label Dose (mg) weight volume (ml) 150mg/ml Solution for Injection CLEXANE syringes
70 75 80 85 90 95 100 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 105 od 112.5 od 120 od 127.5 od 135 od 142.5 od 150 od 0.70 0.76 0.80 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-Q-wave myocardial infarction The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection, administered concurrently with oral aspirin (100 to 325 mg once daily). Treatment with Clexane in these patients should be prescribed for a minimum of 2 days and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days. Dosage chart for 1mg/kg SC treatment of UA or NSTEMI Patient Injection Kg Syringe label Dose (mg) weight volume (ml)
40 45 50 55 60 65 70 75 80 85 90 95 100 40mg / 0.4ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 40 bd 45 bd 50 bd 55 bd 60 bd 65 bd 70 bd 75 bd 80 bd 85 bd 90 bd 95 bd 100 bd 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI Patient Injection Kg Syringe label Dose (mg) weight volume (ml)
105 110 115 120 125 130 135 140 145 150 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 150mg / 1ml 105 bd 110 bd 115 bd 120 bd 125 bd 130 bd 135 bd 140 bd 145 bd 150 bd 0.70 0.74 0.78 0.80 0.84 0.88 0.90 0.94 0.98 1.00
100mg/ml Solution for Injection CLEXANE syringes
150mg/ml Solution for Injection CLEXANE syringes
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. 2
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
How much will be given to you in hospital Your doctor will decide how much to give you. The amount of Clexane Forte 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 Forte Adults including the elderly 1)Treating blood clots that are in your blood The usual dose is 1.5mg for every kilogram of your weight, each day Clexane Forte 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 dose is 1mg for every kilogram of your weight, every 12 hours Clexane Forte will usually be given for 2 to 8 days. Your doctor will normally ask you to take aspirin as well b) After an operation or long periods of bed rest 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 Forte each day for 7 to 10 days. If you are going to have an operation, your first
injection will usually be given 2 hours before your operation If you have a higher risk of getting a clot, you will be given 40mg each day for 7 to 10 days. If you are going to have an operation, your first injection will usually be given 12 hours before your operation If you are bedridden due to illness, you will be normally be given 40mg of Clexane Forte 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) TEMI type of heart attack S 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 60, 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 519350 for every kilogram of your 456732 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 Forte under your skin (subcutaneous injection) The usual dose is 0.75mg for every kilogram of your weight, every 12 hours The maximum amount of Clexane given for the first two injections is 75mg For patients having an operation called Percutaneous Coronary Intervention (PCI) Depending on when you were last given Clexane Forte, 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 1mg for every kilogram of your weight Clexane Forte is added to the tube leaving the body (arterial line) at the start of the dialysis session
3 519350 Treatment of acute ST-segment Elevation Myocardial Infarction 456732 The recommended dose of enoxaparin sodium is a single IV bolus of 30mg (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes) 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.
Patient weight
Dosage chart for 1mg/kg SC treatment of STEMI Injection Kg Syringe label Dose (mg) volume (ml)
40 45 50 55 60 65 70 75 80 85 90 95 100 40mg / 0.4ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 40 bd 45 bd 50 bd 55 bd 60 bd 65 bd 70 bd 75 bd 80 bd 85 bd 90 bd 95 bd 100 bd 0.40 0.45 0.50 0.55 0.60 0.65 0.70 0.75 0.80 0.85 0.90 0.95 1.00
Patient weight
Dosage chart for 1mg/kg SC treatment of STEMI Injection Kg Syringe label Dose (mg) volume (ml)
105 110 115 120 125 130 135 140 145 150 120mg / 0.8ml (1) 120mg / 0.8ml (1) 120mg / 0.8ml (1) 120mg / 0.8ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 150mg / 1ml (1) 105 bd (1) 110 bd (1) 115 bd (1) 120 bd (1) 125 bd (1) 130 bd (1) 135 bd (1) 140 bd (1) 145 bd (1) 150 bd (1) 0.70 (1) 0.74 (1) 0.78 (1) 0.80 (1) 0.84 (1) 0.88 (1) 0.90 (1) 0.94 (1) 0.98 (1) 1.00 (1)
100mg/ml Solution for Injection CLEXANE syringes
100mg/ml Solution for Injection CLEXANE syringes
(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) 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. 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 (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes). Prevention of extracorporeal thrombus formation during haemodialysis: A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1 mg/kg (50 to 100 IU/kg) may be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5 mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular access. Elderly: For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients 75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12 hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the remaining doses). For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is impaired (see also section 4.2 Posology and method of administration: Renal impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the elderly; Renal impairment and Monitoring; section 5.2 Pharmacokinetic properties). 3
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
This amount is usually enough for a belly button or any scar tissue (at least 4 hour session. However, your doctor 5cm away from these) may give you a further dose of 0.5 to 1mg for every kilogram of your weight Instructions on injecting yourself with Clexane Forte: if necessary Children 1)Wash your hands and the area that you This medicine should not be given to will inject with soap and water. Dry children. them. How to give yourself an injection of Clexane Forte If you are able to give Clexane Forte to yourself, your doctor or nurse will show you how to 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. 2)Sit or lie in a comfortable position so you Before injecting yourself with Clexane are relaxed. Make sure you can see the Forte place you are going to inject. A lounge Check the expiry date on the medicine. chair, recliner, or bed propped up with Do not use if the date has passed pillows is ideal. Check the syringe is not damaged and the medicine in it is a clear solution. If not, use another syringe Make sure you know how much you are going to inject Check your abdomen to see if the last injection caused any redness, change 3)Choose an area on the right or left side in skin colour, swelling, oozing or is still of your stomach. This should be at least painful. If so talk to your doctor or nurse 5 centimetres away from your belly Decide where you are going to inject the button and out towards your sides. medicine. Change the place where you Remember: Do not inject yourself inject each time from the right to the within 5cm of your belly button or left side of your stomach. Clexane Forte around existing scars or bruises. Change should be injected just under the skin the place where you inject between the on your stomach, but not too near 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 Forte 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 needle stays 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 sure you hold the skin fold throughout the injection.
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Dosage chart for 0.75mg/kg SC treatment of STEMI (elderly patients aged 75 years only) Patient weight Kg
40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 125 130 135 140 145 150
Syringe label
60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 60mg / 0.6ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 80mg / 0.8ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 100mg / 1ml 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml 120mg / 0.8ml
0.75mg/kg Dose (mg)
30 bd 33.75 bd 37.5 bd 41.25 bd 45 bd 48.75 bd 52.5 bd 56.25 bd 60 bd 63.75 bd 67.5 bd 71.25 bd 75 bd 78.75 bd (1) 82.5 bd (1) 86.25 bd (1) 90 bd (1) 93.75 bd (1) 97.5 bd (1) 101.25 bd (1) 105 bd (1) 108.75 bd (1) 112.5 bd (1)
Adjusted dosing (mg)
30 bd 35 bd 37.5 bd 42.5 bd 45 bd 50 bd 52.5 bd 57.5 bd 60 bd 65 bd 67.5 bd 72.5 bd 75 bd 80 bd (1) 82.5 bd (1) 87.5 bd (1) 90 bd (1) 95 bd (1) 97.5 bd (1) 102 bd (1) 105 bd (1) 111 bd (1) 114 bd (1)
Injection volume (ml)
0.30 0.35 0.375 0.425 0.45 0.5 0.525 0.575 0.60 0.65 0.675 0.725 0.75 0.80 (1) 0.825 (1) 0.875 (1) 0.90 (1) 0.95 (1) 0.975 (1) 0.68 (1) 0.7 (1) 0.74 (1) 0.76 (1)
100mg/ml Solution for Injection CLEXANE syringes
150mg/ml Solution for Injection CLEXANE Forte syringes
(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: (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: Standard dosing
1 mg/kg SC twice daily 1.5 mg/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)
Dosage adjustments for therapeutic dosage range Severe renal impairment
1 mg/kg SC once daily 1 mg/kg SC once daily
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)
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Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
6)Hold the syringe so that the needle 9)Drop the used syringe with its protective 4. Possible side effects is pointing downwards (vertically at a sleeve into the sharps bin provided. Close 90 angle). Insert the full length of the the container lid tightly and place the Like all medicines, Clexane Forte can cause side-effects, although not everybody gets needle into the skin fold. container out of reach of children. them. 7)Press down on the plunger with your When the container is full, give it to finger. This will send the medication into your doctor or home care nurse for Tell a nurse or doctor or go to hospital the fatty tissue of the stomach. Make disposal. Do not put it in the household straight away if you notice any of the following side-effects: sure you hold the skin fold throughout rubbish. the injection. If you have too much or too little Very common (affects more than 1 in 10 people) Clexane Forte If you think that you have used too much Bleeding a lot from a wound. or too little Clexane Forte, tell your doctor, Common (affects 1 to 10 people in a 100) nurse or pharmacist immediately, even if A painful rash of dark red spots under the you have no signs of a problem. If a child skin which do not go away when you put accidentally injects or swallows Clexane pressure on them. You may also notice Forte, take them to a hospital casualty pink patches on your skin. These are department straight away. more likely to appear in the area you 8)Remove the needle by pulling it straight have been injected with Clexane Forte. out. A protective sleeve will automatically If you forget to use Clexane Forte Uncommon (affects 1 to 10 people in a cover the needle. You can now let go of If you forget to give yourself a dose, have it as soon as you remember. Do not give 1,000) the skin fold. yourself a double dose on the same day Sudden severe headache. This could be a sign of bleeding in the brain. to make up for a forgotten dose. Keeping a diary will help to make sure you do not A feeling of tenderness and swelling in your stomach. You may have bleeding miss a dose. inside your stomach. If you stop using Clexane Forte Rare (affects less than 1 in a 1000 people) It is important for you to keep having Clexane Forte injections until your doctor If you have an allergic reaction. The signs may include: a rash, swallowing decides to stop them. If you stop, you or breathing problems, swelling of your Note: the safety system allowing release could get a blood clot which can be very lips, face, throat or tongue. of the protective sleeve can only be dangerous. If you have had a spinal puncture or a activated when the syringe has been spinal anaesthetic and notice tingling, emptied by pressing the plunger all the Blood Tests Using Clexane Forte may affect the results numbness and muscular weakness, way down. of some blood tests. If you are going to particularly in the lower part of your To avoid bruising, do not rub the have a blood test, it is important to tell body. Also if you lose control over your injection site after you have injected your doctor you are having Clexane Forte. yourself.
Dosage adjustments for prophylactic dosage ranges Standard dosing
40 mg SC once daily 20 mg SC once daily
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Severe renal impairment
20 mg SC once daily 20 mg SC once daily
The recommended dosage adjustments do not apply to the haemodialysis indication. *The Clexane 100mg/ml Multidose Vial or Clexane 60mg, 80mg or 100mg pre-filled syringes should be used to administer the IV dose. Moderate and mild renal impairment: Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring is advised. Hepatic impairment: In the absence of clinical studies, caution should be exercised. Body weight: No dosage adjustments are recommended in obesity or low body weight (see also section 4.4 Special warnings and precautions for use: Low body weight and Monitoring; section 5.2 Pharmacokinetic properties). Clexane is administered by subcutaneous injection for the prevention of venous thromboembolic disease, 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 (using the Clexane 100mg/ml Multidose Vial or 60mg, 80mg or 100mg prefilled syringes). 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). 5
Packaging Administration Sanofi Winthrop Industrie - Le Trait - France
Brand name Clexane Eris Article Leaflet Dosage 120/150mg Item code 519350 Quantity 10 SRG Based on 518573 Manuf. site Maisons Alfort GMID code 456732 Country UK (Sale) This artwork proof indicates colour position only. Please refer to Pantone Colour Formula Guide 1000 for exact references Date of creation 31/05/2012 By F Bourgeaux Date of modification By Proof n 1 Pantone Colours used: 1 Reflex Blue PAD Tech. specif. Tech. area Size (mm) N/A TRA-P015644j TRA-P015644-2a 210x315 TC Datamatrix Brandmark/name Country example Font size 519350 A1 - 13.03.2006 CRGB - V1 - 05/2012 9 pt Plan
Your doctor will be able to check this by Each 150mg pre-filled syringe 519350 carrying out a blood test. contains 150mg (15,000 IU 456732 anti-Xa activity) of the active Tell a nurse or doctor as soon as possible Frequency unknown substance, enoxaparin sodium in 1.0ml if you notice any of the following side If Clexane Forte is used for a long period of time, it may increase the risk of you The other ingredient is water for effects: getting a condition called osteoporosis. injections Common (affects 1 to 10 people in a 100) This is when your bones are more likely You bruise more easily than usual. This What Clexane Forte looks like and to break. could be because of a blood problem contents of the pack (thrombocytopenia). Clexane Forte is a clear solution in a 5. How to store and dispose of Clexane Forte You have pain, swelling or irritation in Type I glass pre-filled syringe fitted with the area you have been injected with Keep this medicine in a safe place where an injection needle and needle cap. It is Clexane Forte. This normally gets better children cannot see or reach it. supplied in packs of 2, 10 and 20 syringes. after a few days. Do not use Clexane Forte after the expiry Not all pack sizes may be marketed. Rare (affects less than 1 in a 1000 people) date which is stated on the syringe label Marketing Authorisation If you have a mechanical heart valve, and on the box. The expiry date refers to Holder and Manufacturer treatment with Clexane Forte might the last day of that month. not be sufficient to prevent blood clots. Store below 25C. Do not store in a Marketing Authorisation Holder You may notice that you have difficulty refrigerator or freezer. Store in the original Sanofi, breathing, tiredness or difficulty container. One Onslow Street, Guildford, exercising, chest pain, numbness, feeling Medicines should not be disposed of via Surrey, GU1 4YS, UK sick or loss of consciousness. This could wastewater or household waste. If you are Tel: 01483 505515 - Fax: 01483 535432 be due to a blood clot on the heart valve using this medicine at home you will be email: Other side effects that you should given a container (a sharps bin) to use for uk-medicalinformation@sanofi.com discuss with your nurse or doctor if you disposal. Return the sharps bin or any used Manufacturer are concerned about them: or unused syringes to your doctor or nurse Very common (affects more than 1 in 10 or pharmacist for disposal. These measures Sanofi Winthrop Industrie, 180 Rue Jean Jaures, people) will help to protect the environment. B.P. 37, Changes in the results of blood tests done 94702 Maisons-Alfort Cedex, France. 6. Further information to check how your liver is working. These This leaflet does not contain all the usually go back to normal after you stop What Clexane Forte contains information about your medicine. If you having Clexane Forte. Rare (affects less than 1 in a 1000 people) Each 120mg pre-filled syringe contains have any questions or are not sure about 120mg (12,000 IU anti-Xa activity) of the anything, ask your doctor or pharmacist. Changes in the potassium levels in your active substance, enoxaparin sodium in This leaflet was last revised in 04/2012. blood. This is more likely to happen in 0.8ml people with kidney problems or diabetes. sanofi, 2012
6 519350 After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution 456732 (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
bladder or bowel (so you cannot control when you go to the toilet).
Weight
(Kg) 45 50 55 60 65 70 75 80 85 90 95
Required dose (0.3mg/kg)
(mg) 13.5 15 16.5 18 19.5 21 22.5 24 25.5 27 28.5
Volume to inject when diluted to a final concentration of 3mg/ml
(ml) 4.5 5 5.5 6 6.5 7 7.5 8 8.5 9 9.5
Weight
(Kg) 100 105 110 115 120 125 130
Required dose (0.3mg/kg)
(mg) 30 31.5 33 34.5 36 37.5 39 40.5
Volume to inject when diluted to a final concentration of 3mg/ml
(ml) 10 10.5 11 11.5 12 12.5 13 13.5
135 140 145 150
42 43.5 45
14 14.5 15
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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% dextrose in water. 6.3 Shelf life 24 months. 6.4 Special precautions for storage Do not store above 25C. Do not refrigerate or freeze. Clexane prefilled syringes are single dose containers - discard any unused product. 6.5 Nature and contents of container Solution for injection in Type I glass prefilled syringes fitted with injection needle and an automatic safety device in packs of 2, 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: 16 December 1999 Date of latest renewal: 4 February 2009 10 DATE OF REVISION OF THE TEXT 10/2011 6
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
