Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
WHAT CLEXANE SYRINGES ARE
AND WHAT THEY ARE USED FOR Clexane Syringes contain the active substance called enoxaparin sodium. This belongs to
a group of medicines called 'low molecular weight heparin' or LMWH.
How Clexane Syringes work
Clexane Syringes work 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 Syringes are used for Clexane Syringes can be used to: * Treat blood clots that are in your blood * Stop blood clots from forming in your blood in the following situations: o before and after an operation o when you have a short-term illness and will not be able to move around for some time. o 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).
Do not use Clexane Syringes if:
* you are allergic to:
o enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6)
o 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:
with Eris needle guard safety system
o stomach ulcer, recent surgery of the brain or eyes, or recent bleeding stroke. * you are using Clexane Syringes to treat blood clots and are going to have within 24 hours: oa spinal or lumbar puncture © an operation with epidural or spinal anaesthesia. Do not use Clexane Syringes if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Clexane Syringes.
IN Warnings and precautions
Clexane Syringes 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 Syringes 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 Syringes')
* 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 Syringes.
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 Syringes
has not been evaluated in children or
adolescents.
No. Other medicines and Clexane Syringes
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
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Turn Over
Hy
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ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal antiinflammatory
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 Syringes.
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 breastfeed, you should ask your doctor for advice before taking this medicine.
Driving and using machines
Clexane Syringes do not affect the ability to drive and operate machinery.
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 SYRINGES
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 Syringes. This is because it needs to be given as an injection.
Clexane Syringes are usually given
by injection underneath the skin (subcutaneous).
Clexane Syringes can be given by injection into your vein (intravenous) after certain types of heart attack or operations.
Clexane Syringes can be added to the tube leaving the body (arterial line) at the start of a dialysis session.
Do not inject Clexane Syringes into a muscle.
How much will be given to you
* Your doctor will decide how much Clexane
Syringes 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
Syringes.
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 Syringes.
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 Syringes 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 Syringes each day.
Your doctor will decide how long you
should receive Clexane Syringes.
3) Stopping blood clots when you have unstable angina or after you have had a heart attack
* Clexane Syringes can be used for two different types of heart attack.
* The amount of Clexane Syringes 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 Syringes.
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 Syringes will be given as an injection into your vein.
* At the same time you will also be given Clexane Syringes 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 Syringes.
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 Syringes given for the first two injections is 7,500 IU (75 mg).
* Your doctor will decide how long you should receive Clexane Syringes.
For patients that have an operation
called percutaneous coronary
intervention (PCI):
* Depending on when you were last given Clexane Syringes, your doctor may decide to give an additional dose of Clexane Syringes before a PCI operation. This is by injection into your vein.
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 Syringes are 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 Syringes
If you are able to give Clexane Syringes 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 Syringes
* Collect together the items that you need: 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 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 stomach 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
Instructions on injecting yourself with Clexane Syringes: 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.
956961
* 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.
Selecting your dose 1) Carefully pull off the needle cap from the syringe. Throw away the cap.
* 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).
JZ
2)When the amount of medication in the syringe already matches your prescribed dose, there is no need to adjust the dose. You are now ready to inject.
3) When the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed dose. In that case, you can get rid of any extra medicine by holding the syringe pointing down (to keep the air bubble in the syringe) and ejecting the extra amount into a container.
4)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.
Injecting
1) 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.
2) 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.
3) 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.
4) Remove the needle from the injection site by pulling it straight out. A protective sleeve will automatically cover the needle. You can now let go of the skin fold. The safety system only releases the protective sleeve when the syringe has been emptied by pressing the plunger all the way down.
-3
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 medicine or waste material
should be disposed of in accordance with
local requirements.
Changing anticoagulant medicine
* Changing from Clexane Syringes 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 Syringes.
* Ch from blood thi s called
vitamin-K antagonists (such as warfarin)
to Clexane Syringes
Stop taking the vitamin-K antagonist.
Your doctor will ask you to have blood
tests called INR and tell you when to start
Clexane Syringes.
Changing from Clexane Syringes
to treatment with direct oral
anticoagulants
Stop taking Clexane Syringes. 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 Syringes Stop taking the direct oral anticoagulant. Do not start treatment with Clexane Syringes until 12 hours after the final dose of the direct oral anticoagulant.
If you use more Clexane Syringes than you should
If you think that you have used too much or too little Clexane Syringes, 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 Syringes, take them to a hospital casualty department straight away.
If you forget to use Clexane Syringes
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 Syringes
It is important for you to keep having Clexane Syringes 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
Stop using Clexane Syringes 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).
Stop using Clexane Syringes and seek medical attention immediately if you notice any of the following symptoms:
* Ared, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalized exanthematous pustulosis).
Over
.
Like other similar medicines to reduce blood clotting, Clexane Syringes may
ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal antiinflammatory
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 Syringes.
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 breastfeed, you should ask your doctor for advice before taking this medicine.
Driving and using machines
Clexane Syringes do not affect the ability to drive and operate machinery.
It is advised that the trade name and batch number of the product you are using are recorded by your healthcare professional.
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 Syringes. This is because it needs to be given as an injection.
Clexane Syringes are usually given
by injection underneath the skin (subcutaneous).
Clexane Syringes can be given by injection into your vein (intravenous) after certain types of heart attack or operations.
Clexane Syringes can be added to the tube leaving the body (arterial line) at the start of a dialysis session.
Do not inject Clexane Syringes into a muscle.
How much will be given to you
* Your doctor will decide how much Clexane
Syringes 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
Syringes.
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 Syringes.
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 Syringes 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 Syringes each day.
Your doctor will decide how long you
should receive Clexane Syringes.
3) Stopping blood clots when you have unstable angina or after you have had a heart attack
* Clexane Syringes can be used for two different types of heart attack.
* The amount of Clexane Syringes 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 Syringes.
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 Syringes will be given as an injection into your vein.
* At the same time you will also be given Clexane Syringes 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 Syringes.
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 Syringes given for the first two injections is 7,500 IU (75 mg).
* Your doctor will decide how long you should receive Clexane Syringes.
For patients that have an operation
called percutaneous coronary
intervention (PCI):
* Depending on when you were last given Clexane Syringes, your doctor may decide to give an additional dose of Clexane Syringes before a PCI operation. This is by injection into your vein.
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 Syringes are 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 Syringes
If you are able to give Clexane Syringes 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 Syringes
* Collect together the items that you need: 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 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 stomach 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
Instructions on injecting yourself with Clexane Syringes: 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.
956961
* 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.
Selecting your dose 1) Carefully pull off the needle cap from the syringe. Throw away the cap.
* 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).
JZ
2)When the amount of medication in the syringe already matches your prescribed dose, there is no need to adjust the dose. You are now ready to inject.
3) When the dose depends on your body weight, you may need to adjust the dose in the syringe to match the prescribed dose. In that case, you can get rid of any extra medicine by holding the syringe pointing down (to keep the air bubble in the syringe) and ejecting the extra amount into a container.
4)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.
Injecting
1) 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.
2) 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.
3) 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.
4) Remove the needle from the injection site by pulling it straight out. A protective sleeve will automatically cover the needle. You can now let go of the skin fold. The safety system only releases the protective sleeve when the syringe has been emptied by pressing the plunger all the way down.
-3
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 medicine or waste material
should be disposed of in accordance with
local requirements.
Changing anticoagulant medicine
* Changing from Clexane Syringes 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 Syringes.
* Ch from blood thi s called
vitamin-K antagonists (such as warfarin)
to Clexane Syringes
Stop taking the vitamin-K antagonist.
Your doctor will ask you to have blood
tests called INR and tell you when to start
Clexane Syringes.
Changing from Clexane Syringes
to treatment with direct oral
anticoagulants
Stop taking Clexane Syringes. 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 Syringes Stop taking the direct oral anticoagulant. Do not start treatment with Clexane Syringes until 12 hours after the final dose of the direct oral anticoagulant.
If you use more Clexane Syringes than you should
If you think that you have used too much or too little Clexane Syringes, 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 Syringes, take them to a hospital casualty department straight away.
If you forget to use Clexane Syringes
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 Syringes
It is important for you to keep having Clexane Syringes 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop using Clexane Syringes 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).
Stop using Clexane Syringes and seek medical attention immediately if you notice any of the following symptoms:
* Ared, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalized exanthematous pustulosis).
Over
.
Like other similar medicines to reduce blood clotting, Clexane Syringes 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 o 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 Syringes
* 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
|f 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: www.mhra.gov.uk/yellowcard 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 SYRINGES
Do not store above 25°C. Do not freeze.
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 syringe, particulate matters in the solution, or an abnormal colour of the solution (see "What Clexane Syringes look 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 Syringes contain
* The active substance is enoxaparin sodium * Each mL contains 100 mg enoxaparin sodium, equivalent to 10,000 IU of anti-Xa activity
Each pre-filled syringe of 0.2 mL contains 2,000 IU (20 mg) of enoxaparin sodium Each pre-filled syringe of 0.4 mL contains 4,000 IU (40 mg) of enoxaparin sodium Each pre-filled syringe of 0.6 mL contains 6,000 IU (60 mg) of enoxaparin sodium Each pre-filled syringe of 0.8 mL contains 8,000 IU (80 mg) of enoxaparin sodium Each pre-filled syringe of 1 mL contains 10,000 IU (100 mg) of enoxaparin sodium * The other ingredient is water for injections
What Clexane Syringes look like and contents of the pack
Clexane Syringes is a clear, colourless to yellowish solution for injection in a glass pre-filled syringe (with an automatic safety system).
It is supplied in packs of 2, 5, 6, 10, 12, 20, 24, 30, 50, 100 pre-filled syringes, and in multi-packs of 3 x 10, 9 x 10, 100 x 10, and 200 x 10 pre-filled syringes.
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: [email protected]
Manufacturer
Chinoin Pharmaceutical and Chemical Works Private Co. Ltd
Csanyikvolgy site
Miskolc, Csanyikvélgy
H-3510
Hungary
This leaflet was last revised in March 2026
Other sources of information
Detailed and recent information about this product is available by scanning the QR code which is present below, with a smartphone. The same information is also available at the following URL: www.clexanepatientsupport.co.uk
www.clexanepatientsupport.co.uk
956961
Clexane Pre-filled Syringes (Csanyikvölgy manufacturer) comes as medicine. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Clexane Pre-filled Syringes (Csanyikvölgy manufacturer) is enoxaparin sodium.
Medicines with the same active substance include: AROVI 10,000 IU (100mg/1ml) pre-filled syringe with safety device, AROVI 12,000 IU (120mg/0.8ml) pre-filled syringe with safety device, AROVI 15,000 IU (150mg/1ml) pre-filled syringe with safety device, AROVI 2,000 IU (20mg/0.2ml) pre-filled syringe with safety device, AROVI 4,000 IU (40mg/0.4ml) pre-filled syringe with safety device, AROVI 6,000 IU (60mg/0.6ml) pre-filled syringe with safety device. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Clexane Pre-filled Syringes (Csanyikvölgy manufacturer), as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Clexane Syringes is indicated in adults for:
• Prophylaxis of venous thromboembolic disease in moderate and high-risk surgical patients, in particular those undergoing orthopaedic or general surgery including cancer surgery.
• Prophylaxis of venous thromboembolic disease in medical patients with an acute illness (such as acute heart failure, respiratory insufficiency, severe infections or rheumatic diseases) and reduced mobility at increased risk of venous thromboembolism.
• Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), excluding PE likely to require thrombolytic therapy or surgery.
• Extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer.
• Prevention of thrombus formation in extracorporeal circulation during haemodialysis.
• Acute coronary syndrome:
- Treatment of unstable angina and Non ST-segment elevation myocardial infarction (NSTEMI), in combination with oral acetylsalicylic acid.
- Treatment of acute ST-segment elevation myocardial infarction (STEMI) including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).
Posology
Prophylaxis of venous thromboembolic disease in moderate and high-risk surgical patients
Individual thromboembolic risk for patients can be estimated using validated risk stratification model.
• In patients at moderate risk of thromboembolism, the recommended dose of enoxaparin sodium is 2,000 IU (20 mg) once daily by subcutaneous (SC) injection. Preoperative initiation (2 hours before surgery) of enoxaparin sodium 2,000 IU (20 mg) was proven effective and safe in moderate risk surgery.
• In moderate risk patients, enoxaparin sodium treatment should be maintained for a minimal period of 7 – 10 days whatever the recovery status (e.g. mobility). Prophylaxis should be continued until the patient no longer has significantly reduced mobility.
• In patients at high risk of thromboembolism, the recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily given by SC injection preferably started 12 hours before surgery. If there is a need for earlier than 12 hours enoxaparin sodium preoperative prophylactic initiation (e.g. high risk patient waiting for a deferred orthopaedic surgery), the last injection should be administered no later than 12 hours prior to surgery and resumed 12 hours after surgery.
o For patients who undergo major orthopaedic surgery an extended thromboprophylaxis up to 5 weeks is recommended.
o For patients with a high venous thromboembolism (VTE) risk who undergo abdominal or pelvic surgery for cancer an extended thromboprophylaxis up to 4 weeks is recommended.
Prophylaxis of venous thromboembolism in medical patients
The recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily by SC injection.
Treatment with enoxaparin sodium is prescribed for at least 6 – 14 days whatever the recovery status (e.g. mobility). The benefit is not established for a treatment longer than 14 days.
Treatment of DVT and PE
Enoxaparin sodium can be administered SC either as a once daily injection of 150 IU/kg (1.5 mg/kg) or as twice daily injections of 100 IU/kg (1 mg/kg).
The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding. The dose regimen of 150 IU/kg (1.5 mg/kg) administered once daily should be used in uncomplicated patients with low risk of VTE recurrence. The dose regimen of 100 IU/kg (1 mg/kg) administered twice daily should be used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis.
Enoxaparin sodium treatment is prescribed for an average period of 10 days. Oral anticoagulant therapy should be initiated when appropriate (see “Switch between enoxaparin sodium and oral anticoagulants” at the end of section 4.2).
In the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of its recurrence in patients with active cancer, physicians should carefully assess the individual thromboembolic and bleeding risks of the patient.
The recommended dose is 100 IU/kg (1 mg/kg) administered twice daily by SC injections for 5 – 10 days, followed by a 150 IU/kg (1.5 mg/kg) once daily SC injection up to 6 months. The benefit of continuous anticoagulant therapy should be reassessed after 6 months of treatment.
Prevention of thrombus formation during haemodialysis
The recommended dose is 100 IU/kg (1 mg/kg) of enoxaparin sodium.
For patients with a high risk of haemorrhage, the dose should be reduced to 50 IU/kg (0.5 mg/kg) for double vascular access or 75 IU/kg (0.75 mg/kg) for single vascular access.
During haemodialysis, enoxaparin sodium should be introduced into the arterial line of the circuit at the beginning of the dialysis session. The effect of this dose is usually sufficient for a 4-hour session; however, if fibrin rings are found, for example after a longer than normal session, a further dose of 50 – 100 IU/kg (0.5 – 1 mg/kg) may be given.
No data are available in patients using enoxaparin sodium for prophylaxis or treatment and during haemodialysis sessions.
Acute coronary syndrome: treatment of unstable angina and NSTEMI and treatment of acute STEMI
For treatment of unstable angina and NSTEMI, the recommended dose of enoxaparin sodium is 100 IU/kg (1 mg/kg) every 12 hours by SC injection administered in combination with antiplatelet therapy. Treatment should be maintained for a minimum of 2 days and continued until clinical stabilization. The usual duration of treatment is 2 – 8 days.
Acetylsalicylic acid is recommended for all patients without contraindications at an initial oral loading dose of 150 – 300 mg (in acetylsalicylic acid-naive patients) and a maintenance dose of 75 – 325 mg/day long-term regardless of treatment strategy.
For treatment of acute STEMI, the recommended dose of enoxaparin sodium is a single intravenous (IV) bolus of 3,000 IU (30 mg) plus a 100 IU/kg (1 mg/kg) SC dose followed by 100 IU/kg (1 mg/kg) administered SC every 12 hours (maximum 10,000 IU (100 mg) for each of the first two SC doses). Appropriate antiplatelet therapy such as oral acetylsalicylic acid (75 – 325 mg once daily) should be administered concomitantly unless contraindicated. The recommended duration of treatment is 8 days or until hospital discharge, whichever comes first. 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.
• For dosage in patients ≥ 75 years of age, see paragraph “Elderly”.
• For patients managed with PCI, if the last dose of enoxaparin sodium SC 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 30 IU/kg (0.3 mg/kg) enoxaparin sodium should be administered.
Paediatric population
The safety and efficacy of enoxaparin sodium in the paediatric population have not been established.
Elderly
For all indications except STEMI, no dose reduction is necessary in the elderly patients, unless kidney function is impaired (see below “renal impairment” and section 4.4).
For treatment of acute STEMI in elderly patients ≥75 years of age, an initial IV bolus must not be used. Initiate dosing with 75 IU/kg (0.75 mg/kg) SC every 12 hours (maximum 7,500 IU (75 mg) for each of the first two SC doses only, followed by 75 IU/kg (0.75 mg/kg) SC dosing for the remaining doses). For dosage in elderly patients with impaired kidney function, see below “renal impairment” and section 4.4.
Hepatic impairment
Limited data are available in patients with hepatic impairment (see sections 5.1 and 5.2) and caution should be used in these patients (see section 4.4).
Renal impairment (see sections 4.4 and 5.2)
Severe renal impairment
Enoxaparin sodium is not recommended for patients with end stage renal disease (creatinine clearance <15 ml/min) due to lack of data in this population outside the prevention of thrombus formation in extracorporeal circulation during haemodialysis.
Dosage table for patients with severe renal impairment (creatinine clearance [15 – 30] ml/min):
| Indication | Dosing regimen |
| Prophylaxis of venous thromboembolic disease | 2,000 IU (20 mg) SC once daily |
| Treatment of DVT and PE | 100 IU/kg (1 mg/kg) body weight SC once daily |
| Extended treatment of DVT and PE in patients with active cancer | 100 IU/kg (1 mg/kg) body weight SC once daily |
| Treatment of unstable angina and NSTEMI | 100 IU/kg (1 mg/kg) body weight SC once daily |
| Treatment of acute STEMI (patients under 75)
Treatment of acute STEMI (patients over 75) | 1 x 3,000 IU (30 mg) IV bolus plus 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours No IV initial bolus, 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours |
The recommended dosage adjustments do not apply to the haemodialysis indication.
Moderate and mild renal impairment
Although no dose adjustment is recommended in patients with moderate (creatinine clearance 30 – 50 ml/min) and mild (creatinine clearance 50 – 80 ml/min) renal impairment, careful clinical monitoring is advised.
Method of administration
Clexane Syringes should not be administered by the intramuscular route.
For the prophylaxis of venous thrombo-embolic disease following surgery, treatment of DVT and PE, extended treatment of DVT and PE in patients with active cancer, treatment of unstable angina and NSTEMI, enoxaparin sodium should be administered by SC injection.
For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by a SC injection.
For the prevention of thrombus formation in the extracorporeal circulation during haemodialysis, it is administered through the arterial line of a dialysis circuit.
The pre-filled disposable syringe is ready for immediate use.
SC injection technique:
Injection should be made preferably when the patient is lying down. Enoxaparin sodium is administered by deep SC injection.
Do not expel the air bubble from the syringe before the injection to avoid the loss of drug when using pre-filled syringes. When the quantity of drug to be injected requires to be adjusted based on the patient's body weight, use the graduated pre-filled syringes to reach the required volume by discarding the excess before injection. Please be aware that in some cases it is not possible to achieve an exact dose due to the graduations on the syringe, and in such case the volume shall be rounded up to the nearest graduation.
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 gently held between the thumb and index finger. The skin fold should not be released until the injection is complete. Do not rub the injection site after administration.
The safety system is triggered at the end of the injection.
In case of self-administration, patient should be advised to follow instructions provided in the patient information leaflet included in the pack of this medicine.
IV (bolus) injection (for acute STEMI indication only):
For acute STEMI, treatment is to be initiated with a single IV bolus injection immediately followed by a SC injection.
For IV injection, either the multidose vial or pre-filled syringe can be used.
Enoxaparin sodium should be administered through an IV line. It should not be mixed or co-administered with other medications. To avoid the possible mixture of enoxaparin sodium with other drugs, the IV access chosen should be flushed with a sufficient amount of saline or dextrose solution prior to and following the IV 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 3,000 IU (30 mg) bolus:
For the initial 3,000 IU (30 mg) bolus, using an enoxaparin sodium graduated pre-filled syringe, expel the excessive volume to retain only 3,000 IU (30 mg) in the syringe. The 3,000 IU (30 mg) dose can then be directly injected into the IV line.
• Additional bolus for PCI when last SC administration was given more than 8 hours before balloon inflation:
For patients being managed with PCI, an additional IV bolus of 30 IU/kg (0.3 mg/kg) is to be administered if last SC administration was given more than 8 hours before balloon inflation.
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 IU/ml (3 mg/ml).
To obtain a 300 IU/ml (3 mg/ml) solution, it is recommended to use a 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe, and a 50 ml infusion bag (i.e. using either normal saline solution (0.9%) or 5% dextrose in water) as follows:
• Withdraw 30 ml from the infusion bag with a syringe and discard the liquid. Inject the complete contents of the 6,000 IU (60 mg) enoxaparin sodium pre-filled syringe into the 20 ml 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 IV line.
• After dilution is completed, the volume to be injected can be calculated using the following formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table below. It is recommended to prepare the dilution immediately before use.
Volume to be injected through IV line after dilution is completed at a concentration of 300 IU (3 mg)/ml.
| Weight | Required dose 30 IU/kg (0.3 mg/kg) | Volume to inject when diluted to a final concentration of 300 IU (3 mg)/ml | |
| [Kg] | IU | [mg] | [ml] |
| 45 | 1350 | 13.5 | 4.5 |
| 50 | 1500 | 15 | 5 |
| 55 | 1650 | 16.5 | 5.5 |
| 60 | 1800 | 18 | 6 |
| 65 | 1950 | 19.5 | 6.5 |
| 70 | 2100 | 21 | 7 |
| 75 | 2250 | 22.5 | 7.5 |
| 80 | 2400 | 24 | 8 |
| 85 | 2550 | 25.5 | 8.5 |
| 90 | 2700 | 27 | 9 |
| 95 | 2850 | 28.5 | 9.5 |
| 100 | 3000 | 30 | 10 |
| 105 | 3150 | 31.5 | 10.5 |
| 110 | 3300 | 33 | 11 |
| 115 | 3450 | 34.5 | 11.5 |
| 120 | 3600 | 36 | 12 |
| 125 | 3750 | 37.5 | 12.5 |
| 130 | 3900 | 39 | 13 |
| 135 | 4050 | 40.5 | 13.5 |
| 140 | 4200 | 42 | 14 |
| 145 | 4350 | 43.5 | 14.5 |
| 150 | 4500 | 45 | 15 |
Arterial line injection:
It is administered through the arterial line of a dialysis circuit for the prevention of thrombus formation in the extracorporeal circulation during haemodialysis.
Switch between enoxaparin sodium and oral anticoagulants
Switch between enoxaparin sodium and vitamin K antagonists (VKA)
Clinical monitoring and laboratory tests [prothrombin time expressed as the International Normalized Ratio (INR)] must be intensified to monitor the effect of VKA.
As there is an interval before the VKA reaches its maximum effect, enoxaparin sodium therapy should be continued at a constant dose for as long as necessary in order to maintain the INR within the desired therapeutic range for the indication in two successive tests.
For patients currently receiving a VKA, the VKA should be discontinued, and the first dose of enoxaparin sodium should be given when the INR has dropped below the therapeutic range.
Switch between enoxaparin sodium and direct oral anticoagulants (DOAC)
For patients currently receiving enoxaparin sodium, discontinue enoxaparin sodium and start the DOAC 0 – 2 hours before the time that the next scheduled administration of enoxaparin sodium would be due as per DOAC label.
For patients currently receiving a DOAC, the first dose of enoxaparin sodium should be given at the time the next DOAC dose would be taken.
Administration in spinal/epidural anaesthesia or lumbar puncture
Should the physician decide to administer anticoagulation in the context of epidural or spinal anaesthesia/analgesia or lumbar puncture, careful neurological monitoring is recommended due to the risk of neuraxial haematomas (see section 4.4).
At doses used for prophylaxis
• A puncture-free interval of at least 12 hours shall be kept between the last injection of enoxaparin sodium at prophylactic doses and the needle or catheter placement.
• For continuous techniques, a similar delay of at least 12 hours should be observed before removing the catheter.
• For patients with creatinine clearance [15 – 30] ml/min, consider doubling the timing of puncture/catheter placement or removal to at least 24 hours.
• The 2 hours preoperative initiation of enoxaparin sodium 2,000 IU (20 mg) is not compatible with neuraxial anaesthesia.
At doses used for treatment
• A puncture-free interval of at least 24 hours shall be kept between the last injection of enoxaparin sodium at curative doses and the needle or catheter placement (see also section 4.3).
• For continuous techniques, a similar delay of 24 hours should be observed before removing the catheter.
• For patients with creatinine clearance [15 – 30] ml/min, consider doubling the timing of puncture/catheter placement or removal to at least 48 hours.
• Patients receiving the twice daily doses (i.e. 75 IU/kg (0.75 mg/kg) twice daily or 100 IU/kg (1 mg/kg) twice-daily) should omit the second enoxaparin sodium dose to allow a sufficient delay before catheter placement or removal.
Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided.
Likewise, consider not using enoxaparin sodium until at least 4 hours after the spinal/epidural puncture or after the catheter has been removed. The delay must be based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.
Enoxaparin sodium is contraindicated in patients with:
• Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWH) or to any of the excipients listed in section 6.1;
• History of immune mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4);
• Active clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities;
• Spinal or epidural anaesthesia or loco-regional anaesthesia when enoxaparin sodium is used for treatment in the previous 24 hours (see section 4.4).
Concomitant use not recommended:
• Medicinal products affecting haemostasis (see section 4.4)
It is recommended that some agents which affect haemostasis should be discontinued prior to enoxaparin sodium therapy unless strictly indicated. If the combination is indicated, enoxaparin sodium should be used with careful clinical and laboratory monitoring when appropriate. These agents include medicinal products such as:
- Systemic salicylates, acetylsalicylic acid at anti-inflammatory doses, and NSAIDs including ketorolac,
- Other thrombolytics (e.g. alteplase, reteplase, streptokinase, tenecteplase, urokinase) and anticoagulants (see section 4.2).
Concomitant use with caution:
The following medicinal products may be administered with caution concomitantly with enoxaparin sodium:
• Other medicinal products affecting haemostasis such as:
- Platelet aggregation inhibitors including acetylsalicylic acid used at antiaggregant dose (cardioprotection), clopidogrel, ticlopidine, and glycoprotein IIb/IIIa antagonists indicated in acute coronary syndrome due to the risk of bleeding,
- Dextran 40,
- Systemic glucocorticoids.
• Medicinal products increasing potassium levels:
Medicinal products that increase serum potassium levels may be administered concurrently with enoxaparin sodium under careful clinical and laboratory monitoring (see sections 4.4 and 4.8).
Pregnancy
In humans, there is no evidence that enoxaparin crosses the placental barrier during the second and third trimester of pregnancy. There is no information available concerning the first trimester.
Animal studies have not shown any evidence of fetotoxicity or teratogenicity (see section 5.3). Animal data have shown that enoxaparin passage through the placenta is minimal.
Enoxaparin sodium should be used during pregnancy only if the physician has established a clear need.
Pregnant women receiving enoxaparin sodium should be carefully monitored for evidence of bleeding or excessive anticoagulation and should be warned of the haemorrhagic risk. Overall, the data suggest that there is no evidence for an increased risk of haemorrhage, thrombocytopenia or osteoporosis with respect to the risk observed in non-pregnant women, other than that observed in pregnant women with prosthetic heart valves (see section 4.4).
If an epidural anaesthesia is planned, it is recommended to withdraw enoxaparin sodium treatment before (see section 4.4).
Breast-feeding
It is not known whether unchanged enoxaparin is excreted in human breast milk. In lactating rats, the passage of enoxaparin or its metabolites in milk is very low. The oral absorption of enoxaparin sodium is unlikely. Clexane Syringes can be used during breast-feeding.
Fertility
There are no clinical data for enoxaparin sodium in fertility. Animal studies did not show any effect on fertility (see section 5.3).
Enoxaparin sodium has no or negligible influence on the ability to drive and use machines.
Signs and symptoms
Accidental overdose with enoxaparin sodium after IV, extracorporeal or SC administration may lead to haemorrhagic complications. Following oral administration of even large doses, it is unlikely that enoxaparin sodium will be absorbed.
Management
The anticoagulant effects can be largely neutralized by the slow IV injection of protamine. The dose of protamine depends on the dose of enoxaparin sodium injected; 1 mg protamine neutralizes the anticoagulant effect of 100 IU (1 mg) of enoxaparin sodium, if enoxaparin sodium was administered in the previous 8 hours. An infusion of 0.5 mg protamine per 100 IU (1 mg) of enoxaparin sodium may be administered if enoxaparin sodium was administered greater than 8 hours previous to the protamine administration, or if it has been determined that a second dose of protamine is required. After 12 hours of the enoxaparin sodium injection, protamine administration may not be required. However, even with high doses of protamine, the anti-Xa activity of enoxaparin sodium is never completely neutralized (maximum about 60%) (see the prescribing information for protamine salts).
Ask anything about Clexane Pre-filled Syringes (Csanyikvölgy manufacturer). The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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