CLEXANE MULTIDOSE VIAL - patient leaflet, side effects, dosage

What is in this leaflet

• 1. What Clexane Multidose Vial is and what it is used for

• 2. What you need to know before you use

Clexane Multidose Vial

• 3. How to use Clexane Multidose Vial

• 4. Possible side effects

• 5. How to store Clexane Multidose Vial

• 6. Contents of the pack and other information

1. what clexane multidose vial is and what it is used for

Clexane Multidose Vial contains the active substance called enoxaparin sodium. This belongs to a group of medicines called ‘low molecular weight heparin’ or LMWH.

How Clexane Multidose Vial works

Clexane Multidose Vial works in two ways:

• 1 ) Stopping existing blood clots from getting any bigger. This helps your body to break them down and stops them from causing you harm.

• 2 ) Stopping new blood clots from forming in your blood.

What Clexane Multidose Vial is used for

Clexane Multidose Vial can be used to:

• Treat blood clots that are in your blood
• Stop blood clots from forming in your blood in the following situations:

° before and after an operation

° when you have a short-term illness and will not be able to move around for some time

° if you have experienced a blood clot due to cancer to prevent further clots from forming

• Stop blood clots from forming when you have unstable angina (where not enough blood gets to your heart) or after a heart attack
• Stop blood clots from forming in the tubes of your dialysis machine (used for people with severe kidney problems).

2. what you need to know before you use clexane multidose vial

This medicine contains 15 mg benzyl alcohol per 1 mL. Benzyl alcohol may cause allergic reactions.

Do not use Clexane Multidose Vial if:

• you are allergic to:

° enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6)

° heparin or other ‘low molecular weight heparins’ such as nadroparin, tinzaparin or dalteparin.

Signs of an allergic reaction include: rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, oral cavity, throat or eyes.

• you have had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets) within the last 100 days
• you have antibodies against enoxaparin in your blood
• you are bleeding heavily or have a condition with a high risk of bleeding, such as:

° stomach ulcer, recent surgery of the brain or eyes, or recent bleeding stroke.

• you are using Clexane Multidose Vial to treat blood clots and are going to have within 24 hours: ° a spinal or lumbar puncture

° an operation with epidural or spinal anaesthesia.

• the patient is a premature or newborn baby up to

1 month because of the risk of severe toxicity including abnormal respiration (“gasping syndrome”).

Do not use Clexane Multidose Vial if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Clexane Multidose Vial.

H Warnings and precautions

Clexane Multidose Vial should not be interchanged with other ‘low molecular weight heparins’ such as nadroparin, tinzaparin or dalteparin. This is because they are not exactly the same and do not have the same activity and instructions for use.

Talk to your doctor or pharmacist before using Clexane Multidose Vial if:

• you have ever had a reaction to heparin that caused a severe drop in the number of your clotting cells (platelets)
• you have had a heart valve fitted
• you have endocarditis (an infection of the inner lining of the heart)
• you have a history of gastric ulcer
• you have had a recent stroke
• you have high blood pressure
• you have diabetes or problems with blood vessels in the eye caused by diabetes (called diabetic retinopathy)
• you have had an operation recently on your eyes or brain
• you are elderly (over 65 years old) and especially if you are over 75 years old
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (this may be checked with a blood test)
• you are currently using medicines which affect bleeding (see section 2, ‘Other medicines and Clexane Multidose Vial)
• you have any problem with your spine or you have had spinal surgery.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using Clexane Multidose Vial.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). For patients receiving doses higher than 210 mg/day, this medicine contains more than 24 mg sodium (main component of cooking/table salt) in each dose. This is equivalent to 1.2% of the recommended maximum daily intake of sodium for an adult.

Tests and checks

You may have a blood test before you start using this medicine and at intervals while you are using it; this is to check the level of the clotting cells (platelets) and potassium in your blood.

Use in children and adolescents

The safety and efficacy of Clexane Multidose Vial has not been evaluated in children or adolescents.

Other medicines and Clexane Multidose Vial

Tell your doctor or pharmacist if you are taking or might take any other medicines.

• warfarin – used for thinning the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to stop blood clots from forming (see section 3, ‘Changing anticoagulant medicine’)
• dextran injection – used as a blood replacer
• ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory medicines which are used to treat pain and swelling in arthritis and other conditions
• prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
• medicines which increase potassium levels in your blood such as potassium salts, water pills, and some medicines for heart problems.

Operations and anaesthetics

If you are going to have a spinal or lumbar puncture, or an operation where an epidural or spinal anaesthetic is used, tell your doctor that you are using Clexane Multidose Vial.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you are pregnant and have a mechanical heart valve, you may be at an increased risk of developing blood clots. Your doctor should discuss this with you. If you are breast-feeding or plan to breast-feed, you should ask your doctor for advice before taking this medicine.

Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Driving and using machines

Clexane Multidose Vial does not affect the ability to drive and operate machinery.

Multi-dose vial formulation of Clexane Multidose Vial contains benzyl alcohol

• Multi-dose vial formulation of Clexane Multidose Vial contains benzyl alcohol (15 mg/mL). This is a preservative. It may cause toxic and allergic reactions in infants up to 3 years old. It must not be used in premature babies or babies up to 1 month old due to the risk of severe toxicity including abnormal respiration.
• It is recommended to use the Clexane Multidose Vial formulation without benzyl alcohol in pregnant women.

It is advised that the trade name and batch number of the product you are using are recorded by your healthcare professional.

3. how to use clexane multidose vial

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Having this medicine

• Your doctor or nurse will normally give you Clexane Multidose Vial. This is because it needs to be given as an injection.
• Clexane Multidose Vial is usually given by injection underneath the skin (subcutaneous).
• Clexane Multidose Vial can be given by injection into your vein (intravenous) after certain types of heart attack or operations.
• Clexane Multidose Vial can be added to the tube leaving the body (arterial line) at the start of a dialysis session.
• Do not inject Clexane Multidose Vial into a muscle.

How much will be given to you

• Your doctor will decide how much Clexane Multidose Vial to give you. The amount 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 Multidose Vial.

1) Treating blood clots that are in your blood

• The usual dose is 150 IU (1.5 mg) for every kilogram of your bodyweight once a day or 100 IU (1 mg) for every kilogram of your bodyweight twice a day.
• Your doctor will decide how long you should receive Clexane Multidose Vial.

• 2) Stopping blood clots from forming in your blood during operations or periods of limited mobility due to an illness

• The dose will depend on how likely you are to develop a clot. You will be given 2,000 IU (20 mg) or 4,000 IU (40 mg) of Clexane Multidose Vial each day.
• If you are going to have an operation your first injection will be usually given 2 hours or 12 hours before your operation.
• If you have restricted mobility due to illness, you will normally be given 4,000 IU (40 mg) of Clexane Multidose Vial each day.
• Your doctor will decide how long you should receive Clexane Multidose Vial.

3) Stopping blood clots when you have unstable angina or after you have had a heart attack

• Clexane Multidose Vial can be used for two different types of heart attack.
• The amount of Clexane Multidose Vial given to you will depend on your age and the kind of heart attack you have had.

NSTEMI (Non-ST segment Elevation Myocardial Infarction) type of heart attack:

• The usual dose is 100 IU (1 mg) for every kilogram of your bodyweight every 12 hours.
• Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive Clexane Multidose Vial.

STEMI (ST segment Elevation Myocardial Infarction) type of heart attack if you are under 75 years old:

• An initial dose of 3,000 IU (30 mg) of Clexane Multidose Vial will be given as an injection into your vein.
• At the same time you will also be given Clexane Multidose Vial as an injection underneath your skin (subcutaneous injection). The usual dose is 100 IU (1 mg) for every kilogram of your bodyweight, every 12 hours.
• Your doctor will normally ask you to take aspirin (acetylsalicylic acid) as well.
• Your doctor will decide how long you should receive Clexane Multidose Vial.

STEMI type of heart attack if you are 75 years old or older:

• The usual dose is 75 IU (0.75 mg) for every kilogram of your bodyweight, every 12 hours.
• The maximum amount of Clexane Multidose Vial given for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should receive Clexane Multidose Vial.

For patients that have an operation called percutaneous coronary intervention (PCI):

• Depending on when you were last given Clexane Multidose Vial, your doctor may decide to give an additional dose of Clexane Multidose Vial before a PCI operation. This is by injection into your vein.

P72

• 4) Stopping blood clots from forming in the tubes of your dialysis machine

• The usual dose is 100 IU (1 mg) for every kilogram of your bodyweight.
• Clexane Multidose Vial is added to the tube leaving the body (arterial line) at the start of a dialysis session.
• This amount is usually enough for a 4-hour session. However, your doctor may give you a futher dose of 50 IU to 100 IU (0.5 to 1 mg) for every kilogram of your bodyweight, if necessary.

Giving yourself an injection of Clexane Multidose Vial

If you are able to give Clexane Multidose Vial 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. Performing the injection properly under the skin (called “subcutaneous injection”) will help reduce pain and bruising at the injection site.

Before injecting yourself with Clexane Multidose Vial

• Collect together the items that you need: Clexane multi-dose vial, syringe, alcohol swab or soap and water, and sharps container
• Check the expiry date on the medicine. Do not use if the date has passed
• Check the vial is not damaged and the medicine in it is a clear solution. If not, use another vial
• Make sure you know how much you are going to inject
• Check your abdomen to see if the last injection caused any redness, change in skin colour, swelling, oozing or is still painful. If so talk to your doctor or nurse
• Clexane Multidose Vial should be injected just under the skin on your stomach, but not too near the belly button or any scar tissue (at least 5cm away from these). Decide where you are going to inject the medicine. Change the place where you inject each time from the right to the left side of your stomach.

Instructions on injecting yourself with Clexane Multidose Vial:

Preparing the injection site

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

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

• 2) Wash your hands. Cleanse (do not rub) the area that you will inject with an alcohol swab or soap and water.

• 3) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.

Injecting

• 1) Withdraw the correct dose from the vial with an appropriate syringe. A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by tapping on the syringe with the needle pointing down. You are now ready to inject.

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

• Make sure you hold the skin fold throughout the injection.

• 3) Hold the syringe so that the needle is pointing straight down (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

• 4) Press down on the plunger with your thumb. This will send the medication into the fatty tissue of the stomach. Complete the injection using all of the medicine in the syringe.

• 5) Remove the needle from the injection site by pulling it straight out. Orient the needle away from you and others. You can now let go of the skin fold.

When you have finished

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

• 2) Drop the used syringe into a sharps container. Close the container lid tightly and place the container out of reach of children. When the container is full, dispose of it as your doctor or pharmacist has instructed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Changing anticoagulant medicine

• Changing from Clexane Multidose Vial to blood thinners called vitamin-K antagonists (such as warfarin)

Your doctor will ask you to have blood tests called INR and tell you when to stop Clexane Multidose Vial.

• Changing from blood thinners called vitamin-K antagonists (such as warfarin) to Clexane Multidose Vial

Stop taking the vitamin-K antagonist. Your doctor will ask you to have blood tests called INR and tell you when to start Clexane Multidose Vial.

• Changing from Clexane Multidose Vial to treatment with direct oral anticoagulants Stop taking Clexane Multidose Vial. Start taking the direct oral anticoagulant 0 to 2 hours before the time you would have had the next injection, then continue as normal.
• Changing from treatment with direct oral anticoagulants to Clexane Multidose Vial Stop taking the direct oral anticoagulant. Do not start treatment with Clexane Multidose Vial until 12 hours after the final dose of the direct oral anticoagulant.

If you use more Clexane Multidose Vial than you should

If you think that you have used too much or too little Clexane Multidose Vial, tell your doctor or pharmacist or nurse immediately, even if you have no signs of a problem. If a child accidentally injects or swallows Clexane Multidose Vial, take them to a hospital causualty department straight away.

If you forget to use Clexane Multidose Vial

If you forget to give yourself a dose, have it as soon as you remember. Do not give yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary will help to make sure you do not miss a dose.

If you stop using Clexane Multidose Vial

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

fjl Stop using Clexane Multidose Vial and talk to a doctor or nurse straight away if you get any signs of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, oral cavity, throat or eyes).

Like other similar medicines to reduce blood clotting, Clexane Multidose Vial may cause bleeding. This may be life-threatening. In some cases the bleeding may not be obvious.

Talk to your doctor straight away if:

• you have any bleeding that does not stop by itself
• you have signs of too much bleeding – such as being very weak, tired, pale or dizzy with headache or unexplained swelling.

Your doctor may decide to keep you under closer observation or change your medicine.

You should tell your doctor straight away:

• if you have any sign of blockage of a blood vessel by a blood clot such as:

° cramping pain, redness, warmth, or swelling in one of your legs – these are symptoms of deep vein thrombosis

° breathlessness, chest pain, fainting or coughing up blood – these are symptoms of a pulmonary embolism

• if you have a painful rash of dark red spots under the skin which do not go away when you put pressure on them.

Your doctor may request you perform a blood test to check your platelet count.

Other side effects

Very common (may affect more than 1 in 10 people):

• Bleeding
• increases in liver enzymes.

Common (may affect up to 1 in 10 people):

• you bruise more easily than usual – this could be because of a blood problem with low platelet counts
• pink patches on your skin – these are more likely to appear in the area you have been injected with Clexane Multidose Vial
• skin rash (hives, urticaria)
• itchy red skin
• bruising or pain at the injection site
• decreased red blood cell count
• high platelet counts in the blood
• headache.

Uncommon (may affect up to 1 in 100 people):

• 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 in your stomach
• large red irregularly shaped skin lesions with or without blisters
• skin irritation (local irritation)
• yellowing of your skin or eyes and your urine becomes darker in colour – this could be a liver problem.

Rare (may affect up to 1 in 1,000 people):

• severe allergic reaction – the signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• increased potassium in your blood – this is more likely to happen in people with kidney problems or diabetes. Your doctor will be able to check this by carrying out a blood test
• an increase in the number of eosinophils in your blood – your doctor will be able to check this by carrying out a blood test
• hair loss
• osteoporosis (a condition where your bones are more likely to break) after long term use
• tingling, numbness and muscular weakness (particularly in the lower part of your body) when you have had a spinal puncture or a spinal anaesthetic
• loss of control over your bladder or bowel (so you cannot control when you go to the toilet)
• hard mass or lump at the injection site.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store clexane multidose vial

Do not store above 25°C. Use within 28 days after opening.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not use this medicine if you notice a breach in the vial, particulate matters in the solution, or an abnormal colour of the solution (see “What Clexane Multidose Vial looks like and contents of the pack”). Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

These measures will help protect the environment.

6. contents of the pack and other information

What Clexane Multidose Vial contains

• The active substance is enoxaparin sodium
• Each mL contains 100 mg enoxaparin sodium, equivalent to 10,000 IU of anti-Xa activity
• Each multi-dose vial of 3 mL contains 30,000 IU (300 mg) of enoxaparin sodium
• The other ingredients are benzyl alcohol and water for injections

What Clexane Multidose Vial looks like and contents of the pack

Clexane multi-dose vial contains a clear, colourless to yellowish solution for injection in a glass vial.

It is supplied in packs of 1, 5, and 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi

410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK.

Tel: 0800 035 2525

email:

Manufacturer

Sanofi-Aventis

Deutschland GmbH

Bruningstrafie 50 /

Industriepark Hochst

65926 Frankfurt am Main

Germany

This leaflet was last revised in September 2021

© Sanofi, 1997 – 2021