Clexane

Package leaflet: Information for the patient

CLEXANE 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringes, 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringes, T 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringes, T 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringes, T 10,000 IU (100 mg)/1 ml solution for injection in pre-filled syringes

enoxaparin sodium
Please read all of this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What CLEXANE/CLEXANE T is and what it is used for
2. What you need to know before using CLEXANE/CLEXANE T
3. How to use CLEXANE/CLEXANE T
4. Possible side effects
5. How to store CLEXANE/CLEXANE T
6. Contents of the pack and other information

1. What CLEXANE/CLEXANE T is and what it is used for

CLEXANE/CLEXANE T contains an active substance called enoxaparin sodium.
This belongs to a group of medicines known as 'low molecular weight heparins' or LMWH.
How CLEXANE/CLEXANE T works
CLEXANE/CLEXANE T works in two ways.

1. It prevents the growth of existing blood clots. This helps the body to break them down and prevents them from causing harm.
2. It prevents the formation of new blood clots.
   What CLEXANE/CLEXANE T is used for
   CLEXANE/CLEXANE T may be used to:

• Treat existing blood clots
• Prevent the formation of blood clots in the following situations:
  • before and after surgery
  • in case of a short-term illness requiring limited mobility for a period of time
• Prevent the formation of blood clots in unstable angina (when insufficient blood reaches the heart) or after a heart attack
• Prevent the formation of blood clots in the tubing of a dialysis machine (used by people with severe kidney problems).

2. What you need to know before using CLEXANE/CLEXANE T

Do not use CLEXANE/CLEXANE T if:

• you are allergic to:
• enoxaparin sodium or to any of the other ingredients of this medicine (listed in section 6).
• heparin or to other low molecular weight heparins such as for example nadroparin, tinzaparin or dalteparin. Signs of an allergic reaction include: rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat or eyes.
• you have previously had a reaction to heparin that caused a severe decrease in the number of blood clotting cells (platelets) within the last 100 days.
• you have antibodies against enoxaparin in your blood.
• you are actively bleeding or have a disease with a high risk of bleeding such as:
• stomach ulcer, recent brain or eye surgery, or recent hemorrhagic stroke.
• you are using CLEXANE/CLEXANE T to treat blood clots and you are scheduled to undergo within 24 hours:
• a lumbar or spinal puncture
• surgery with spinal or epidural anaesthesia. Do not use CLEXANE/CLEXANE T if you are in any of the above conditions. If you are unsure, contact your doctor or pharmacist before using CLEXANE/CLEXANE T.

Warnings and precautions
CLEXANE/CLEXANE T must not be substituted with other low molecular weight heparins such as
nadroparin, tinzaparin or dalteparin. These medicines are not identical and do not have the same
activity or usage instructions.
Consult your doctor or pharmacist before using CLEXANE/CLEXANE T if:

• you have ever had a reaction to heparin causing a significant reduction in blood clotting cells (platelets)
• you have had a heart valve implanted
• you suffer from endocarditis (an infection of the inner lining of the heart)
• you suffer from stomach ulcer
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or diabetes-related eye blood vessel problems (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if over 75
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (this can be checked with a blood test)
• you are currently taking medicines that may affect bleeding (see section 2, “Other medicines and CLEXANE/CLEXANE T”).
• you have any spinal problems or have undergone spinal surgery. If you are in any of the above conditions (or are unsure), contact your doctor or pharmacist before using CLEXANE/CLEXANE T.

For patients receiving doses higher than 210 mg/day, this medicine contains more than 24 mg of
sodium (the main component of table salt) per dose. This corresponds to 1.2%
of the maximum recommended daily intake of sodium for an adult.
Tests and monitoring
You may need to have a blood test before starting this medicine and regularly during treatment to monitor
your blood clotting cell levels (platelets) and your blood potassium levels.
Use in children and adolescents
The safety and efficacy of CLEXANE/CLEXANE T have not been established in children or adolescents.
Other medicines and CLEXANE/CLEXANE T
Inform your doctor or pharmacist if you are taking or might take any other medicines.

• warfarin – used to thin the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to prevent blood clots (see section 3, “Changing anticoagulant medicine”)
• dextran injection – used as a blood substitute
• ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) 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 that increase potassium levels in the blood such as potassium salts, diuretics and some medicines for heart conditions.

Surgery and anaesthesia
If you are scheduled to undergo a spinal or lumbar puncture or surgery involving epidural or spinal
anaesthesia, inform your doctor that you are using CLEXANE/CLEXANE T.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, 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 increased risk of developing
blood clots. Your doctor will discuss this with you.
If you are breastfeeding or planning to breastfeed, ask your doctor for advice before taking this medicine.
Driving and using machines
CLEXANE/CLEXANE T does not affect the ability to drive or operate machinery.
It is recommended that the healthcare provider records the brand name and batch number of the product you are using.

3. How to use CLEXANE/CLEXANE T

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Administration of the medicine

• CLEXANE/CLEXANE T is usually administered by a doctor or nurse, as it must be given by injection.
• CLEXANE/CLEXANE T is usually administered by subcutaneous (under the skin) injection.
• CLEXANE/CLEXANE T may be administered by intravenous (into a vein) injection after certain types of heart attack or surgical procedures.
• CLEXANE/CLEXANE T may be added to the arterial line at the beginning of a dialysis session.
• Do not inject CLEXANE/CLEXANE T into a muscle.

Dosage

• Your doctor will decide how much CLEXANE/CLEXANE T you will receive. The dose depends on the reason for its use.
• If you have kidney problems, you may need to receive a lower dose of CLEXANE/CLEXANE T.

1. Treatment of blood clots

• The usual dose is 150 IU (1.5 mg) per kilogram of body weight once daily or 100 IU (1 mg) per kilogram of body weight twice daily.
• Your doctor will decide how long you should receive CLEXANE/CLEXANE T.

2. Prevention of blood clot formation during

surgical procedures or periods of reduced mobility due to illness

• The dose depends on how likely a clot is to develop. You may receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of CLEXANE/CLEXANE T daily.
• If undergoing a surgical procedure, the first injection is usually given 2 hours or 12 hours before surgery.
• For reduced mobility due to illness, 4,000 IU (40 mg) of CLEXANE/CLEXANE T is usually administered daily.
• Your doctor will decide how long you should receive CLEXANE/CLEXANE T.

3. Prevention of blood clots in cases of unstable angina or after a heart attack

• CLEXANE/CLEXANE T can be used for two different types of heart attack.
• The amount of CLEXANE/CLEXANE T administered depends on your age and the type of heart attack you have had.

Heart attack of the NSTEMI type (myocardial infarction without ST-segment elevation):

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also ask you to take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive CLEXANE/CLEXANE T.

Heart attack of the STEMI type (myocardial infarction with ST-segment elevation) if you are under 75 years of age:

• An initial dose of 3,000 IU (30 mg) of CLEXANE/CLEXANE T will be administered as an intravenous injection.
• At the same time, you will also receive CLEXANE/CLEXANE T as a subcutaneous injection. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also ask you to take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive CLEXANE/CLEXANE T.

Heart attack of the STEMI type if you are 75 years of age or older:

• The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum dose of CLEXANE/CLEXANE T for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should receive CLEXANE/CLEXANE T.

For patients undergoing a procedure called percutaneous coronary intervention:

• Depending on when CLEXANE/CLEXANE T was last administered, your doctor may decide to give an additional dose of CLEXANE/CLEXANE T before a percutaneous coronary intervention. The medicine will be injected into a vein.

4. Prevention of clot formation in the dialysis machine tubing

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• CLEXANE/CLEXANE T is added to the tube carrying blood away from the body (arterial line) at the beginning of a dialysis session. This amount is usually sufficient for a 4-hour session. However, your doctor may administer an additional dose of 50–100 IU (0.5–1 mg) per kilogram of body weight, if necessary.

How to self-administer a CLEXANE/CLEXANE T injection
If you are able to self-inject CLEXANE/CLEXANE T, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself unless you have been properly trained. If you are unsure what to do, contact your doctor or nurse immediately. Properly administering the subcutaneous ("under-the-skin") injection will help reduce pain and bruising at the injection site.

Before self-injecting CLEXANE/CLEXANE T

• Gather the necessary supplies: syringe, alcohol swab, soap and water, and a sharps container
• Check the medicine’s expiration date. Do not use if the date has passed
• Ensure the syringe is undamaged and the medicine inside is a clear solution. If not, use another syringe
• Make sure you know the correct amount of medicine to inject
• Examine the abdominal area to see if the previous injection caused redness, skin discoloration, swelling, discharge, or lingering pain. If so, contact your doctor or nurse.

Instructions for self-injecting CLEXANE/CLEXANE T
(Instructions for pre-filled syringes without safety system)

Preparing the injection site

1. Choose an area to the right or left of the abdomen. The site should be at least 5 centimeters away from the navel and toward the sides.

• Do not inject within 5 centimeters of the navel or near existing scars or bruises.
• Alternate injection sites between the left and right sides of the abdomen, depending on where the last injection was given.

2. Wash your hands. Clean (do not rub) the injection area with an alcohol swab or soap and water.
3. Sit or lie down in a comfortable, relaxed position. Make sure you can clearly see the injection site. A reclining chair, adjustable lounge chair, or bed with pillows is ideal.

Selecting the dose

1. Carefully remove the needle cap from the syringe. Discard the cap.

• Do not press the plunger before injecting to remove air bubbles. Doing so may cause loss of medicine.
• Once the cap is removed, avoid letting the needle touch anything to ensure it remains clean (sterile).

2. If the amount of medicine in the syringe already matches the prescribed dose, no dose adjustment is needed. You are now ready to inject.
3. If the dose is based on body weight, you may need to adjust the dose in the syringe to match the prescribed amount. In this case, remove the excess medicine by holding the syringe downward (to keep the air bubble in the syringe) and expel the excess into a container.
4. A drop may appear at the tip of the needle. If so, remove the drop before injecting by gently tapping the syringe with the needle pointing downward. You are now ready to inject.

Injection

1. Hold the syringe in your dominant hand (like a pencil). With your other hand, gently pinch the cleaned area of the abdomen between your thumb and index finger to create a skin fold.

• Make sure to keep the skin fold throughout the entire injection.

2. Hold the syringe so that the needle points downward (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with your thumb to deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all the medicine in the syringe.
4. Remove the needle straight out from the injection site. Move the needle away from yourself and others. You may now release the skin fold.

After the injection

1. To prevent bruising, do not rub the injection site.
2. Dispose of the used syringe in the appropriate sharps container. Securely close the container lid and keep it out of children’s reach. When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions.
   Any unused medicine or waste material derived from this medicine must be disposed of in accordance with local regulations.

(Instructions for pre-filled syringes with ERIS™-type safety system)

Injection site preparation
p1) Choose an area on the right or left side of the abdomen. This area must be at least 5 centimeters
away from the navel and toward the sides.
Do not inject within 5 centimeters of the navel or near scars or
existing bruises.
Change the injection site between the left and right sides of the abdomen,
depending on the area where the last injection was administered.

2) Wash your hands. Clean (do not rub) the area where you will give the injection with an alcohol wipe or
soap and water.
3) Sit or lie in a comfortable position so that you are relaxed. Make sure you can
see the area where you will give the injection. A reclining chair, lounge chair, or a bed with
cushions is ideal.
Dose selection
1) Carefully remove the needle cap from the syringe. Discard the cap.
Do not push the plunger before giving the injection to remove air bubbles.
Doing so may cause loss of medication.
Once the cap has been removed, avoid letting the needle touch anything to
ensure the needle remains clean (sterile).

2. When the amount of medicine in the syringe already corresponds to the prescribed dose, there is no need to adjust the dose. You are now ready for the injection.
3. When the dose depends on body weight, it may be necessary to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove the excess medicine by holding the syringe with the needle pointing downwards (to keep the air bubble in the syringe) and expel the excess amount into a container.
4. A drop may appear at the tip of the needle. If this happens, remove the drop before performing the injection by gently tapping the syringe with the needle pointing downwards. You are now ready for the injection.
   Injection
5. Hold the syringe in the hand you write with (like a pencil). With the other hand, gently pinch the cleaned area of the abdomen between your index finger and thumb to create a skin fold. Make sure to keep the skin fold throughout the entire injection.
6. Hold the syringe so that the needle points downward (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3) Press the plunger with your thumb. This will deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all 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 release the skin fold. The safety mechanism
releases the protective sleeve only when the syringe has been emptied by fully pressing
the plunger.

When finished
1) To avoid bruising, do not rub the injection site.
2) Dispose of the used syringe in an appropriate sharps container. Close
the container lid securely and keep the container out of the reach of children. When the
container is full, dispose of it according to your doctor’s or pharmacist’s instructions.

Unused medicinal product or waste material resulting from such medicinal product must be disposed of in accordance with local regulations.
Local regulations.

(Instructions for pre-filled syringes with PREVENTIS™ type safety system)

Preparing the injection site
p1) Choose an area on the right or left side of the abdomen. This area must be at least 5 centimeters
away from the navel and toward the sides.
Do not administer the injection within 5 centimeters of the navel or near scars or
existing bruises.
Alternate the injection site between the left and right side of the abdomen,
depending on the area used for the last injection.

2) Wash your hands. Clean (do not rub) the area where you will give the injection with an alcohol swab or
soap and water.
3) Sit or lie down in a comfortable position so you can relax. Make sure you can see the area where you will give the injection. A reclining chair, lounge chair, or a bed with
cushions is ideal.
Dose selection
1) Carefully remove the needle cap from the syringe. Discard the cap.
Do not press the plunger before giving the injection to remove air bubbles.
Doing so may result in loss of medication.
Once the cap is removed, avoid letting the needle touch anything to ensure
the needle remains clean (sterile).

2. When the amount of medicine in the syringe already corresponds to the prescribed dose, it is not necessary to adjust the dose. You are now ready for the injection.
3. When the dose depends on body weight, it may be necessary to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove the excess medicine by holding the syringe with the needle pointing downwards (to keep the air bubble in the syringe) and expelling the excess amount into a container.
4. A drop may appear at the tip of the needle. If this happens, remove the drop before performing the injection by gently tapping the syringe with the needle pointing downwards. You are now ready for the injection.

Injection

1. Hold the syringe in your writing hand (like a pencil). With the other hand, gently pinch the cleaned area of the abdomen between your index finger and thumb to create a skin fold. Make sure to maintain the skin fold throughout the entire injection.
2. Hold the syringe so that the needle points downward (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with your thumb. This will deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all the medicine in the syringe.
4. Remove the needle from the injection site by pulling it straight out while keeping your fingers on the plunger. Move the needle away from yourself and others, then firmly push the plunger to activate the safety mechanism. The protective sleeve will automatically cover the needle. You will hear an audible "click" confirming activation of the protective sleeve. You may now release the skin fold.

When finished
1) To avoid bruising, do not rub the injection site immediately after administering the injection.
2) Dispose of the used syringe in an appropriate sharps container. Close the container lid securely
and place the container out of reach of children. When the container is full, dispose of it according to the instructions provided by your doctor or pharmacist.

Unused medicine or waste material from this medicine must be disposed of in accordance with local regulations.
Local regulations apply.

Switching from one anticoagulant medicine to another

• Switching from CLEXANE/CLEXANE T to anticoagulants known as vitamin K antagonists (such as warfarin)
  Your doctor will ask you to have a blood test called INR and will tell you when to stop treatment with CLEXANE/CLEXANE T.

• Switching from anticoagulants known as vitamin K antagonists (such as warfarin) to CLEXANE/CLEXANE T
  Stop treatment with vitamin K antagonists. Your doctor will ask you to have a blood test called INR and will tell you when to start treatment with CLEXANE/CLEXANE T.

• Switching from CLEXANE/CLEXANE T to direct oral anticoagulants
  Stop treatment with CLEXANE/CLEXANE T. Start taking the direct oral anticoagulant 0 to 2 hours before the time when your next injection would have been administered, then continue as usual.

• Switching from treatment with direct oral anticoagulants to CLEXANE/CLEXANE T
  Stop treatment with the direct oral anticoagulant. Start treatment with CLEXANE/CLEXANE T only 12 hours after the last dose of the direct oral anticoagulant.

If you use more CLEXANE/CLEXANE T than you should
If you think you have used too much or too little CLEXANE/CLEXANE T, inform your doctor, nurse, or pharmacist immediately, even if you do not have any signs of problems. If a child accidentally injects or swallows CLEXANE/CLEXANE T, take them immediately to the emergency room.

If you forget to use CLEXANE/CLEXANE T
If you forget to take a dose, take it as soon as you remember. Do not take a double dose on the same day to make up for the missed dose. Keeping a diary may help you avoid missing doses.

If you stop using CLEXANE/CLEXANE T
It is important that you continue to receive CLEXANE/CLEXANE T injections until your doctor decides to stop them. Stopping treatment on your own may be dangerous, as a blood clot could form.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Serious side effects

Stop using CLEXANE/CLEXANE T and contact your doctor or nurse immediately if you develop any signs of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth cavity, throat or eyes).

Stop using enoxaparin and contact a doctor immediately if you notice any of the following symptoms:

• A widespread red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis).

Like other similar medicines (medicines to reduce blood clotting), CLEXANE/CLEXANE T can cause bleeding, which may potentially be life-threatening. In some cases, bleeding may not be obvious.

Contact your doctor immediately:

• If you experience any bleeding events that do not stop on their own.
• If you experience signs of excessive bleeding (severe weakness, fatigue, paleness, dizziness, headache, or unexplained swelling). Your doctor may decide to monitor you closely or change your medication.

You must inform your doctor immediately:

• If you experience signs of a blood vessel blockage caused by a clot, such as:
  • Painful cramps, redness, warmth, or swelling in one of the legs – symptoms of deep vein thrombosis.
  • Shortness of breath, chest pain, fainting, or coughing up blood – symptoms of pulmonary embolism.
• If you develop a painful rash of dark red spots under the skin that do not fade when pressed. Your doctor may ask you to have a blood test to check your platelet count.

Other side effects

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

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Bruising more easily than usual. This may be due to a blood disorder with low platelet count.
• Pink spots on the skin. These are more likely to appear at the site where CLEXANE/CLEXANE T was injected.
• Skin rash (urticaria).
• Red, itchy skin.
• Bruising or pain at the injection site.
• Decrease in red blood cells.
• High number of platelets in the blood.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache which could be a sign of bleeding in the brain.
• Pain and swelling in the abdomen. This could be a sign of bleeding in the stomach.
• Large, irregularly shaped red lesions on the skin, with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and darkening of the urine. This could indicate a liver problem.

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

• Severe allergic reaction. Signs of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Increased potassium levels in the blood. This is more likely in people with kidney problems or diabetes. Your doctor may monitor levels through a blood test.
• Increased number of eosinophils in the blood. Your doctor may monitor levels through a blood test.
• Hair loss.
• Osteoporosis (a condition that makes bones more fragile) after prolonged use.
• Tingling, numbness, and muscle weakness (particularly in the lower part of the body) if you undergo spinal puncture or receive spinal anaesthesia.
• Loss of bladder or bowel control (inability to control when to go to the bathroom).
• Hard mass or nodule at the injection site.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at:
http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CLEXANE/CLEXANE T

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 stated on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any breakage in the syringe, particles in the solution, or an abnormal colour of the solution (see "Description of the appearance of CLEXANE/CLEXANE T and contents of the pack").
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What CLEXANE/CLEXANE T contains

• The active substance is enoxaparin sodium.
• Each ml contains 100 mg of enoxaparin sodium, equivalent to 10,000 IU of anti-Xa activity. Each 0.2 ml pre-filled syringe contains 2,000 IU (20 mg) of enoxaparin sodium. Each 0.4 ml pre-filled syringe contains 4,000 IU (40 mg) of enoxaparin sodium. Each 0.6 ml pre-filled syringe contains 6,000 IU (60 mg) of enoxaparin sodium. Each 0.8 ml pre-filled syringe contains 8,000 IU (80 mg) of enoxaparin sodium. Each 1.0 ml pre-filled syringe contains 10,000 IU (100 mg) of enoxaparin sodium.
• The other component is water for injections.

Description of the appearance of CLEXANE/CLEXANE T and pack contents
CLEXANE/CLEXANE T is a clear, colourless or slightly yellowish injectable solution in a glass pre-filled syringe (with or without automatic safety system).
It is available in packs of 2, 5, 6, 10, 12, 20, 24, 30, 50, 100 pre-filled syringes and in multiple 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 Authorization Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milano

Manufacturer
Sanofi Winthrop Industrie
Boulevard Industriel
76580 Le Trait - France
or
Sanofi Winthrop Industrie
180, rue Jean Jaurès
94700 Maisons-Alfort - France
or
Chinoin Pharmaceutical and Chemical Works Private Co. Ltd
Csanyikvölgy site
Miskolc, Csanyikvölgy
H-3510 - Hungary
or
Sanofi-Aventis Private Co. Ltd
Budapest Logistics and Distribution Platform
Bdg. DC5, Campona utca 1.
Budapest, 1225 - Hungary
or
Sanofi-Aventis GmbH
Turm A, 29. OG, Wienerbergstraße 11
1100 Vienna - Austria
or
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst-Brüningstraße 50
65926 Frankfurt am Main
Germany

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, France, Portugal: Lovenox.
Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, United Kingdom: Clexane.
Italy: Clexane T.
Denmark, Finland, Iceland, Norway, Sweden: Klexane.

Other sources of information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/it .

Patient Information Leaflet

CLEXANE T 12,000 IU (120 mg)/0.8 ml solution for injection in pre-filled syringe, T 15,000 IU (150 mg)/1 ml solution for injection in pre-filled syringe

enoxaparin sodium
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What CLEXANE T is and what it is used for
2. What you need to know before using CLEXANE T
3. How to use CLEXANE T
4. Possible side effects
5. How to store CLEXANE T
6. Contents of the pack and other information

1. What CLEXANE T is and what it is used for

CLEXANE T contains an active substance called enoxaparin sodium. This belongs to a group of medicines called 'low molecular weight heparins' or LMWH.
How CLEXANE T works
CLEXANE T works in two ways.
3) It blocks the growth of existing blood clots. This helps the body to break them down and prevents them from causing harm.
4) It blocks the formation of new blood clots.
What CLEXANE T is used for
CLEXANE T may be used for:

• Treating blood clots that are already present
• Preventing the formation of blood clots in the following situations:
• before and after surgery
• in case of a short-term illness requiring limited mobility for a period of time
• Preventing the formation of blood clots in unstable angina (when insufficient blood reaches the heart) or after a heart attack
• Preventing the formation of blood clots in the dialysis machine tubing (used by people with severe kidney problems).

2. What you need to know before using CLEXANE T

Do not use CLEXANE T if:

• you are allergic to:
• enoxaparin sodium or to any of the other ingredients of this medicine (listed in section 6)
• heparin or to 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 previously had a reaction to heparin that caused a severe decrease in the number of blood clotting cells (platelets) within the last 100 days
• you have antibodies against enoxaparin in your blood
• you are currently bleeding heavily or have a disease with a high risk of bleeding such as:
• stomach ulcer, recent brain or eye surgery, or recent haemorrhagic stroke
• you are using CLEXANE T to treat blood clots and you will undergo within 24 hours:
• a lumbar or spinal puncture
• surgery under spinal or epidural anaesthesia.
  Do not use CLEXANE T if you are in any of the above conditions. If you are unsure, contact your doctor or pharmacist before using CLEXANE T.

Warnings and precautions
CLEXANE T must not be substituted with other low molecular weight heparins such as nadroparin,
tinzaparin or dalteparin. These medicines are not identical and do not have the same
activity or the same instructions for use.
Consult your doctor or pharmacist before using CLEXANE T if:

• you have ever had a reaction to heparin that caused a significant reduction in the number of blood clotting cells (platelets)
• you have had a heart valve implanted
• you suffer from endocarditis (an infection of the inner lining of the heart)
• you suffer from a stomach ulcer
• you have recently had a stroke
• you have high blood pressure
• you have diabetes or diabetes-related eye blood vessel problems (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if over 75
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (levels can be checked with a blood test)
• you are currently taking medicines that affect bleeding (see section 2, “Other medicines and CLEXANE T”)
• you have any spinal problems or have undergone spinal surgery.
  If you are in any of the above conditions (or are unsure), contact your doctor or pharmacist before using CLEXANE T.

For patients receiving doses higher than 210 mg/day, this medicine contains more than 24 mg of
sodium (the main component of table salt) per dose. This corresponds to 1.2%
of the maximum daily sodium intake recommended for an adult.

Tests and monitoring
You may need to have a blood test before starting this medicine and regularly during treatment
to monitor the levels of blood clotting cells (platelets) and the level of potassium in your blood.

Use in children and adolescents
The safety and efficacy of CLEXANE T have not been established in children or adolescents.

Other medicines and CLEXANE T
Inform your doctor or pharmacist if you are taking or might take any other medicine.

• warfarin – used to thin the blood
• aspirin (also known as acetylsalicylic acid or ASA), clopidogrel or other medicines used to prevent clot formation (see section 3, “Changing anticoagulant medicine”)
• dextran injection – used as a blood substitute
• ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) 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 that increase potassium levels in the blood such as potassium salts, diuretics and certain medicines for heart problems.

Surgery and anaesthesia
If you are scheduled for a spinal or lumbar puncture or for surgery involving epidural or spinal anaesthesia, inform your doctor that you are using CLEXANE T.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning a pregnancy, 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 increased risk of developing blood clots. Your doctor will discuss this with you.
If you are breastfeeding or planning to breastfeed, ask your doctor for advice before taking this medicine.

Driving and using machines
CLEXANE T does not affect the ability to drive or operate machinery.
It is recommended that the healthcare provider records the brand name and batch number of the product you are using.

3. How to use CLEXANE T

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Administration of the medicine

• CLEXANE T is normally administered to you by a doctor or nurse, as it must be given by injection.
• CLEXANE T is usually administered by subcutaneous injection (under the skin).
• CLEXANE T may be administered by intravenous injection (into a vein) after certain types of heart attack or surgical procedures.
• CLEXANE T may be added to the tube draining from the body (arterial line) at the beginning of a dialysis session.
• Do not inject CLEXANE T into a muscle.

Dosage

• Your doctor will decide how much CLEXANE T you will be given. The dose depends on the reason for its use.
• If you have kidney problems, you may need to receive a lower dose of CLEXANE T.

1. Treatment of blood clots present in the blood

• The usual dose is 150 IU (1.5 mg) per kilogram of body weight once daily or 100 IU (1 mg) per kilogram of body weight twice daily.
• Your doctor will decide how long you should receive CLEXANE T.

2. Prevention of blood clot formation during surgical procedures or

periods of reduced mobility due to illness

• The dose depends on how likely it is for a clot to develop. You may receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of CLEXANE T daily.
• If you are undergoing surgery, the first injection is usually given 2 hours or 12 hours before the operation.
• If you have reduced mobility due to illness, you will usually be given 4,000 IU (40 mg) of CLEXANE T daily.
• Your doctor will decide how long you should receive CLEXANE T.

3. Prevention of blood clots in unstable angina or after a heart attack

• CLEXANE T can be used for two different types of heart attack.
• The amount of CLEXANE T administered depends on your age and the type of heart attack you have had.

Heart attack of type NSTEMI (myocardial infarction without ST-segment elevation):

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also ask you to take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive CLEXANE T.

Heart attack of type STEMI (myocardial infarction with ST-segment elevation) if you are less than 75 years old:

• An initial dose of 3,000 IU (30 mg) of CLEXANE T will be administered as an intravenous injection.
• At the same time, you will also receive CLEXANE T as a subcutaneous injection. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also ask you to take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive CLEXANE T.

Heart attack of type STEMI if you are 75 years of age or older:

• The usual dose is 75 IU (0.75 mg) per kilogram of body weight every 12 hours.
• The maximum amount of CLEXANE T administered for the first two injections is 7,500 IU (75 mg).
• Your doctor will decide how long you should receive CLEXANE T.

For patients undergoing a procedure called percutaneous coronary intervention:

• Depending on when CLEXANE T was last administered, your doctor may decide to give an additional dose of CLEXANE T before percutaneous coronary intervention. The medicine will be injected into a vein.

4. Prevention of clot formation in the dialysis machine tubing

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• CLEXANE T is added to the tube carrying blood away from the body (arterial line) at the beginning of a dialysis session. This amount is usually sufficient for a 4-hour session. However, the doctor may administer an additional dose of 50–100 IU (0.5–1 mg) per kilogram of body weight, if necessary.

How to self-inject CLEXANE T
If you are able to self-administer CLEXANE T, your doctor or nurse will show you how to do it. Do not attempt to give the injection yourself unless you have been properly trained. If you are unsure about what to do, consult your doctor or nurse immediately. Proper administration of the subcutaneous injection (an injection under the skin) will help reduce pain and bruising at the injection site.

Before self-injecting CLEXANE T

• Gather the necessary supplies: syringe, alcohol swab or soap and water, and a sharps container
• Check the expiry date of the medicine. Do not use it if the date has passed
• Ensure the syringe is undamaged and the medicine inside is a clear solution. If not, use another syringe
• Make sure you know how much medicine you need to inject
• Examine your abdomen to check whether the previous injection caused redness, skin discoloration, swelling, oozing, or tenderness. If so, contact your doctor or nurse.

Instructions for self-injecting CLEXANE T:
(Instructions for pre-filled syringes without safety system)
Preparing the injection site

1. Choose an area on the right or left side of the abdomen. The site should be at least 5 cm away from the navel and toward the sides.

• Do not inject within 5 cm of the navel or near existing scars or bruises.
• Alternate the injection site between the left and right sides of the abdomen, depending on where the last injection was given.

2. Wash your hands. Clean (do not rub) the injection area with an alcohol swab or soap and water.
3. Sit or lie down in a comfortable position to help you relax. Make sure you can clearly see the injection site. A reclining chair, recliner, or bed with pillows is ideal.

Selecting the dose

1. Carefully remove the needle cap from the syringe. Discard the cap.

• Do not press the plunger before injecting to remove air bubbles. This may cause loss of medication.
• Once the cap is removed, avoid letting the needle touch anything to keep it clean (sterile).

2. If the amount of medicine in the syringe already matches the prescribed dose, no dose adjustment is needed. You are now ready to inject.
3. If the dose is based on body weight, you may need to adjust the dose in the syringe to match the prescribed amount. In this case, excess medicine can be removed by holding the syringe with the needle pointing downward (to keep the air bubble in the syringe) and expelling the excess into a container.
4. A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by gently tapping the syringe with the needle pointing downward. You are now ready to inject.

Injection

1. Hold the syringe in your dominant hand (like a pencil). With your other hand, gently pinch the cleaned area of the abdomen between your thumb and index finger to create a skin fold.

• Make sure to keep the skin fold throughout the injection.

2. Hold the syringe so that the needle points downward (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with your thumb to deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all the medicine in the syringe.
4. Remove the needle straight out from the injection site. Move the needle away from yourself and others. You may now release the skin fold.

When finished

1. To prevent bruising, do not rub the injection site.
2. Dispose of the used syringe in a sharps container. Close the container tightly and keep it out of the reach of children. When the container is full, dispose of it according to your doctor’s or pharmacist’s instructions.
   Any unused medicine or waste material derived from this medicine must be disposed of in accordance with local regulations.

(Instructions for pre-filled syringes with automatic safety system type ERIS™)

Injection site preparation
p1) Choose an area on the right or left side of the abdomen. This should be at least 5
centimeters away from the navel and towards the sides.
Do not inject within 5 centimeters of the navel or near scars or
existing hematomas.
Change the injection site between the left and right sides of the abdomen,
depending on the area where the last injection was administered.

2) Wash your hands. Clean (do not rub) the area where you will give the injection with an alcohol wipe or
soap and water.
3) Sit or lie down in a comfortable position so you can relax. Make sure you can
see the area where you will give the injection. A reclining chair, lounge chair, or a bed with
cushions is ideal.
Dose Selection
1) Carefully remove the needle cap from the syringe. Discard the cap.
Do not push the plunger before giving the injection to remove air bubbles.
Doing so may result in loss of medication.
Once the cap is removed, avoid letting the needle touch anything to
ensure the needle remains clean (sterile).

2. When the amount of medicine in the syringe already corresponds to the prescribed dose,
   there is no need to adjust the dose. You are now ready for injection.
3. When the dose depends on body weight, it may be necessary to adjust the dose in the
   syringe to match the prescribed dose. In this case, you can remove the excess medicine
   by holding the syringe with the needle pointing downwards (to keep the air bubble in the syringe) and expelling the excess amount into a container.
4. A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by gently tapping the syringe with the needle pointing downwards. You are now ready
   for injection.
   Injection
5. Hold the syringe in the hand you write with (like a pencil). With the other hand, gently pinch the cleaned area of the abdomen between your index finger and thumb to create a skin fold.
   Make sure to keep holding the skin fold throughout the entire injection.
6. Hold the syringe so that the needle points downward (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3) Press the plunger with your thumb. This will deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all 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 release the skin fold. The safety mechanism
releases the protective sleeve only after the syringe has been emptied by fully depressing
the plunger.

When you have finished

1. To avoid bruising, do not rub the site where you have just administered the injection.
2. Dispose of the used syringe in a sharps container. Close the container lid securely, and store the container out of the reach of children. When the container is full, dispose of it according to your doctor's or pharmacist's instructions.

Unused medicinal product or waste material derived from such medicinal product must be disposed of in accordance with
current local regulations.

Instructions for pre-filled syringes with automatic safety system type PREVENTIS™

Preparation of the injection site
p1) Choose an area on the right or left side of the abdomen. This should be at least 5
centimeters away from the navel and toward the sides.
Do not inject within 5 centimeters of the navel or near scars or
existing bruises.
Change the injection site between the left and right sides of the abdomen,
depending on the area where you administered the last injection.

2) Wash your hands. Clean (do not rub) the area where you will give the injection with an alcohol wipe or
soap and water.
3) Sit or lie in a comfortable position so that you are relaxed. Make sure you can see the area where you will give the injection. A reclining chair, lounge chair, or a bed with pillows is ideal.
3) Sit or lie in a comfortable position so that you are relaxed. Make sure you can see the area where you will give the injection. A reclining chair, lounge chair, or a bed with pillows is ideal.
cuscini è l'ideale.
Dose Selection
1) Carefully remove the needle cap from the syringe. Discard the cap.
Do not push the plunger before giving the injection to remove air bubbles.
Doing so may result in loss of medication.
Once the cap is removed, avoid letting the needle touch anything to keep it clean (sterile).
Make sure the needle remains clean (sterile).

2. When the amount of medicine in the syringe already corresponds to the prescribed dose,
   it is not necessary to adjust the dose. You are now ready for the injection.
3. When the dose depends on body weight, it may be necessary to adjust the dose in the
   syringe to match the prescribed dose. In this case, you can remove the excess medicine
   by holding the syringe with the needle pointing downward (to keep the air bubble in the syringe) and expelling the excess amount into a container.
4. A drop may appear at the tip of the needle. If this occurs, remove the drop before injecting by gently tapping the syringe with the needle pointing downward. You are now ready
   for the injection.

Injection

1. Hold the syringe in your writing hand (like a pencil). With the other hand, gently pinch the cleaned area of the abdomen between your index finger and thumb to create a skin fold.
   Make sure to keep the skin fold throughout the entire injection.
2. Hold the syringe so that the needle points downward (vertically at a 90° angle). Insert the full length of the needle into the skin fold.

3. Press the plunger with your thumb. This will deliver the medicine into the fatty tissue of the abdomen. Complete the injection by using all the medicine in the syringe.
4. Remove the needle from the injection site by pulling it straight out while keeping your fingers on the plunger. Move the needle away from yourself and others, then firmly push the plunger to activate the safety mechanism. The protective sleeve will automatically cover the needle. You will hear an audible "click" confirming activation of the protective sleeve. You may now release the skin fold.

When finished
1) To avoid bruising, do not rub the injection site.
2) Dispose of the used syringe in a sharps container. Close the container lid securely
and store the container out of reach of children. When the container is
full, dispose of it according to your doctor's or pharmacist's instructions.

Unused medicine or waste material resulting from such medicine must be disposed of in accordance with local regulations in force.
Local regulations.

Switching from one anticoagulant medicine to another

• Switching from CLEXANE T to anticoagulants called vitamin K antagonists (such as warfarin)
  Your doctor will ask you to have a blood test called INR and will tell you when to stop treatment with CLEXANE T.

• Switching from anticoagulants called vitamin K antagonists (such as warfarin) to CLEXANE T
  Stop treatment with vitamin K antagonists. Your doctor will ask you to have a blood test called INR and will tell you when to start treatment with CLEXANE T.

• Switching from CLEXANE T to direct oral anticoagulants
  Stop treatment with CLEXANE T. Start taking the direct oral anticoagulant 0 to 2 hours before the time of your next scheduled injection, then continue as usual.

• Switching from direct oral anticoagulants to CLEXANE T
  Stop treatment with the direct oral anticoagulant. Start treatment with CLEXANE T only 12 hours after the last dose of the direct oral anticoagulant.

If you use more CLEXANE T than you should
If you think you have used too much or too little CLEXANE T, inform your doctor, nurse, or pharmacist immediately, even if you do not notice any signs of problems. If a child accidentally injects or swallows CLEXANE T, take them immediately to the emergency department.

If you forget to use CLEXANE T
If you forget to take a dose, take it as soon as you remember. Do not take a double dose on the same day to make up for the missed dose. Keeping a diary will help you ensure you do not miss a dose.

If you stop using CLEXANE T
It is important that you continue your CLEXANE T injections until your doctor decides to stop them. Stopping treatment on your own may be very dangerous, as it could lead to the formation of a blood clot.

If you have any further questions about the use of this medicine, consult your doctor, 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 T and contact your doctor or nurse immediately if you develop any signs of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat or eyes).

Stop using enoxaparin and contact a doctor immediately if you notice any of the following symptoms:

• A widespread red, scaly rash with lumps under the skin and blisters accompanied by fever. Symptoms usually occur early in treatment (acute generalized exanthematous pustulosis).

Like other similar medicines used to reduce blood clotting, CLEXANE T can cause bleeding, which may potentially be life-threatening. In some cases, bleeding may not be obvious.

Contact your doctor immediately:

• If you experience any type of bleeding that does not stop on its own.
• If you experience signs of excessive bleeding (extreme weakness, fatigue, paleness, dizziness, headache, or unexplained swelling).

Your doctor may decide to monitor you closely or switch your medicine.

You must inform your doctor immediately:

• If you have signs of a blood vessel blockage caused by a clot, such as:
• painful cramps, redness, warmth or swelling in one of the legs – signs of deep vein thrombosis
• shortness of breath, chest pain, fainting or coughing up blood – signs of pulmonary embolism
• If you develop a painful rash with dark red spots under the skin that do not fade when pressed. Your doctor may ask you to have a blood test to check your platelet count.

Other side effects
Very common (may affect more than 1 in 10 people)

• Bleeding.
• Increased liver enzymes.

Common (may affect up to 1 in 10 people)

• Bruising more easily than usual. This may be due to a blood disorder with low platelet count.
• Pink spots on the skin. These are more likely to appear at the site where CLEXANE T was injected.
• Skin rash (bumps, hives).
• Red, itchy skin.
• Bruising or pain at the injection site.
• Decrease in red blood cells.
• High number of platelets in the blood.
• Headache.

Uncommon (may affect up to 1 in 100 people)

• Sudden, severe headache that could be a sign of bleeding in the brain.
• Pain and swelling in the stomach. This could be a sign of bleeding in the stomach.
• Large, irregularly shaped red skin lesions with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and darker urine. This could indicate a liver problem.

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

• Severe allergic reaction. Signs of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• Increased potassium levels in the blood. This is more likely in people with kidney problems or diabetes. Your doctor may check this with a blood test.
• Increased number of eosinophils in the blood. Your doctor may check this with a blood test.
• Hair loss.
• Osteoporosis (a condition that makes bones more fragile) after prolonged use.
• Tingling, numbness, and muscle weakness (particularly in the lower part of the body) if you undergo spinal puncture or receive spinal anaesthesia.
• Loss of bladder or bowel control (inability to control when to go to the toilet).
• Hard mass or nodule at the injection site.

Reporting of side effects
If you get any side effect, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CLEXANE T

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 stated on the label. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any breakage in the syringe, particles in the solution, or an abnormal colour of the solution (see "Description of the appearance of CLEXANE T and contents of the pack").
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CLEXANE T contains

• The active substance is enoxaparin sodium.
• Each ml contains 150 mg of enoxaparin sodium, equivalent to 15,000 IU anti-Xa activity. Each 0.8 ml pre-filled syringe contains 12,000 IU (120 mg) of enoxaparin sodium. Each 1.0 ml pre-filled syringe contains 15,000 IU (150 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

Description of the appearance of CLEXANE T and contents of the pack
CLEXANE T is a clear, colourless to yellowish injectable solution in a glass pre-filled syringe (with or without automatic safety system).
It is supplied in packs of 2, 5, 6, 10, 20, 30, 50 pre-filled syringes and in multiple packs of 3 x 10 pre-filled syringes.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan, Italy

Manufacturer
Sanofi Winthrop Industrie
180, rue Jean Jaurès
94700 Maisons-Alfort - France
or
Sanofi-Aventis Private Co. Ltd
Budapest Logistics and Distribution Platform
Bdg. DC5, Campona utca 1.
Budapest, 1225 - Hungary
or
Sanofi-Aventis GmbH
Turm A, 29. OG, Wienerbergstraße 11
1100 Vienna – Austria
or
Sanofi Winthrop Industrie
1051 Boulevard Industriel
76580 Le Trait
France
or
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst-Brüningstraße 50
65926 Frankfurt am Main - Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria, France, Portugal: Lovenox.
Belgium, Germany, Czech Republic, Greece, Luxembourg, Netherlands, Slovenia, Spain: Clexane.
Czech Republic, Hungary, Ireland, Poland, Slovak Republic, United Kingdom: Clexane Forte.
Italy: Clexane T.
Finland, Norway, Sweden: Klexane.

Further sources of information
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it/it