CLEXANE 2000 U.I. Injectable solution

Зміст інструкції

1. CLEXANE 2,000 IU (20 mg)/0.2 ml injectable solution in pre-filled syringes, 4,000 IU (40 mg)/0.4 ml injectable solution in pre-filled syringes, T 6,000 IU (60 mg)/0.6 ml injectable solution in pre-filled syringes, T 8,000 IU (80 mg)/0.8 ml injectable solution in pre-filled syringes, T 10,000 IU (100 mg)/1 ml injectable solution in pre-filled syringes
   1. What is CLEXANE/CLEXANE T 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. Treatment of blood clots
   5. Prevention of blood clot formation during
   6. Prevention of blood clots in the presence of unstable angina or after a myocardial infarction
   7. Prevention of clot formation in the dialysis machine tubes
   8. Possible side effects
   9. How to store CLEXANE/CLEXANE T
   10. Package Contents and Other Information
2. CLEXANE T 12,000 IU (120 mg)/0.8 ml injectable solution in pre-filled syringe, T 15,000 IU (150 mg)/1 ml injectable solution in pre-filled syringe
   1. What is CLEXANE T and what is it used for
   2. What you need to know before you use CLEXANE T
   3. How to use CLEXANE T
   4. Treatment of blood clots
   5. Prevention of blood clot formation during surgical procedures or
   6. Prevention of blood clots in the presence of unstable angina or after a myocardial infarction
   7. Prevention of clot formation in the dialysis machine tubes
   8. Possible side effects
   9. How to store CLEXANE T
   10. Package contents and other information

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

enoxaparin sodium

Read this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you use 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 is CLEXANE/CLEXANE T and what it is used for

CLEXANE/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/CLEXANE T works
CLEXANE/CLEXANE T works in two ways.

• 1) It blocks the growth of existing blood clots. This helps the body to break them down and prevent them from causing damage.
• 2) It blocks the formation of new blood clots.

What CLEXANE/CLEXANE T is used for
CLEXANE/CLEXANE T can be used for:

• Treating blood clots
• Preventing the formation of blood clots in the following situations:
• before and after surgery
• in case of a short-term illness that involves a period of reduced mobility for a limited time
• Preventing the formation of blood clots in the presence of unstable angina (when not enough blood reaches the heart) or after a heart attack
• Preventing the formation of blood clots in the tubes of the 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 any of the other ingredients of this medicine (listed in section 6).
• heparin or other low molecular weight heparins such as nadroparin, tinzaparin or dalteparin. The signs of an allergic reaction include: skin rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat or eyes.
• you have had a reaction to heparin that caused a severe reduction in the number of cells responsible for blood clotting (platelets) in the last 100 days
• you have antibodies against enoxaparin in your blood.
• you are bleeding heavily or have a condition with a high risk of bleeding such as:
• stomach ulcer, recent surgery to the brain or eyes or recent haemorrhagic stroke.
• you are using CLEXANE/CLEXANE T to treat blood clots and will 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 not sure, contact your doctor or pharmacist before using CLEXANE/CLEXANE T.

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

• you have ever had a reaction to heparin that caused a significant reduction in the number of cells responsible for blood clotting (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 had a stroke recently
• you have high blood pressure
• you have diabetes or problems with the blood vessels in the eye caused by diabetes (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), 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 (the values can be checked with a blood test)
• you are currently using medicines that can affect bleeding (see section 2, “Other medicines and CLEXANE/CLEXANE T”).
• you have problems with your spine or have undergone spine surgery. If you are in any of the above conditions (or are not sure), contact your doctor or pharmacist before using CLEXANE/CLEXANE T.

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

Tests and checks
You may need to have a blood test before starting to use this medicine and
regularly during its use, to check the level of cells responsible for blood clotting
(platelets) and the level of potassium in your blood.

Use in children and adolescents
The safety and efficacy of CLEXANE/CLEXANE T has not been evaluated in children or adolescents.

Other medicines and CLEXANE/CLEXANE T
Tell 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 the anticoagulant medicine”)
• dextran injection - used as a blood substitute
• ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory drugs 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 the level of potassium in the blood such as potassium salts, diuretics and some medicines for heart problems.

Surgery and anaesthesia
If you are going to have a spinal or lumbar puncture or surgery involving the use of
epidural or spinal anaesthetic, tell your doctor that you are using CLEXANE/CLEXANE T.

Pregnancy and breastfeeding
If you are pregnant, suspect you are 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 greater risk of developing
blood clots. Your doctor will discuss this with you.
If you are breastfeeding or plan to breastfeed, ask your doctor
before taking this medicine.

Driving and using machines
CLEXANE/CLEXANE T does not impair the ability to drive and use machines.
It is recommended that the healthcare professional records the trade name and batch number of the product that
you are using.

3. How to use CLEXANE/CLEXANE T

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

Taking the medicine

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

How much medicine will be administered to you

• The doctor will decide how much CLEXANE/CLEXANE T to administer to you. The quantity depends on the reason why it is being used.
• If you have kidney problems you may need to receive a lower quantity of CLEXANE/CLEXANE T.

1. Treatment of blood clots

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

2. Prevention of blood clot formation during

surgical interventions or periods of reduced mobility due to illness

• The dose depends on how likely it is to develop a clot. You may receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of CLEXANE/CLEXANE T per day.
• If surgery is planned, the first injection is usually administered 2 hours or 12 hours before the operation.
• In case of reduced mobility due to illness, the following are normally administered
• 4,000 IU (40 mg) of CLEXANE/CLEXANE T per day.
• The doctor will decide how long you should receive CLEXANE/CLEXANE T.

3. Prevention of blood clots in the presence of unstable angina or after a myocardial infarction

• CLEXANE/CLEXANE T can be used for two different types of myocardial infarction.
• The amount of CLEXANE/CLEXANE T administered depends on age and the type of myocardial infarction experienced.

NSTEMI type myocardial infarction (myocardial infarction without ST segment elevation):

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

STEMI type myocardial infarction (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 injection into a vein.
• At the same time, you will also receive CLEXANE/CLEXANE T as a subcutaneous injection (subcutaneous injection). The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Normally, your doctor will ask you to also take aspirin (acetylsalicylic acid).
• The doctor will decide how long you should receive CLEXANE/CLEXANE T.

STEMI type myocardial infarction 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/CLEXANE T administered for the first two injections is
• 7,500 IU (75 mg).
• The 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 administered last, the doctor may decide to administer 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 tubes

• The usual dose is 100 IU (1 mg) per each kilogram of body weight.
• CLEXANE/CLEXANE T is added to the outgoing tube 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 each kilogram of body weight, if necessary.

How to give yourself an injection of CLEXANE/CLEXANE T
If you are able to administer CLEXANE/ CLEXANE T to yourself, the doctor or nurse will show you how to do it. Do not attempt to give yourself the injection if you have not been trained on how to do it.
If you are unsure about what to do, consult your doctor or nurse immediately. Correct execution
of the injection under the skin (called "subcutaneous injection") will help reduce pain and
hematoma at the injection site.

Before giving yourself an injection with CLEXANE/CLEXANE T

• Collect the necessary items: syringe, alcohol swab, water and soap, and sharps container
• Check the expiration date of the medicine. Do not use it if the date has passed
• Check that the syringe is not damaged and that the medicine inside is a clear solution. If not, use another syringe
• Make sure you know how much medicine you need to inject
• Check the abdomen to see if the previous injection has caused redness, skin discoloration, swelling, leakage, or is still painful. If so, contact your doctor or nurse.

Instructions on how to inject CLEXANE/CLEXANE T:
(Instructions for prefilled syringes without a safety system)
Preparation of the injection site

• 1) Choose an area to the right or left of the abdomen. This should be at least 5 centimeters away from the navel and towards the flanks.
• Do not inject within 5 centimeters of the navel or around existing scars or bruises.
• Change the injection site between the left and right sides of the abdomen, depending on the area where you last injected.

• 2) Wash your hands. Clean (do not rub) the area where you will inject with an alcohol swab or soap and water.
• 3) Sit or lie down in a comfortable position so you are relaxed. Make sure you can see the area where you will inject. A reclining chair or a bed with pillows 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. This can lead to loss of medication.
• Once the cap is removed, avoid touching the needle with anything. This is to ensure that 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, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove excess medication by holding the syringe upside down (to keep the air bubble in the syringe) and expel the excess amount into a container.
• 4) A drop may appear on the tip of the needle. If this happens, remove the drop before giving the injection by tapping the syringe with the needle pointing downwards. You are now ready for the injection.

Injection

• 1) 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 form a fold in the skin.
• Make sure to keep the fold in the skin throughout the injection.
• 2) Hold the syringe so that the needle is pointing downwards (vertically at a 90° angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with your thumb. This will send the medicine into the fatty tissue of the abdomen. Complete the injection using all the medicine in the syringe.
• 4) Remove the needle from the injection site by pulling it straight out. Keep the needle away from yourself and others. Now you can release the skin fold.

When you are finished

• 1) To avoid bruising, do not rub the area where you just gave the injection.
• 2) Dispose of the used syringe in the appropriate sharps container. Close the container lid tightly and place 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 from such medicine must be disposed of in accordance with
local regulations.

(Instructions for prefilled syringes with ERIS™ safety system)

• 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, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove excess medication by holding the syringe upside down (to keep the air bubble in the syringe) and expel the excess amount into a container.
• 4) A drop may appear on the tip of the needle. If this happens, remove the drop before giving the injection by tapping the syringe with the needle pointing downwards. You are now ready for the injection.

Injection

• 1) 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 form a fold in the skin. Make sure to keep the fold in the skin throughout the injection.
• 2) Hold the syringe so that the needle is pointing downwards (vertically at a 90° angle). Insert the entire length of the needle into the skin fold.

releases the protective sleeve only when the syringe has been emptied by fully
pressing the plunger.

(Instructions for prefilled syringes with PREVENTIS™ safety system)

• 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, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove excess medication by holding the syringe upside down (to keep the air bubble in the syringe) and expel the excess amount into a container.
• 4) A drop may appear on the tip of the needle. If this happens, remove the drop before giving the injection by tapping the syringe with the needle pointing downwards. You are now ready for the injection.

Injection

• 1) Hold the syringe in the hand you write with (like a pencil). With the other hand, gently pinch the clean area of your abdomen between your index finger and thumb to form a fold in the skin. Make sure to maintain the skin fold throughout the duration of the injection.
• 2) Hold the syringe so that the needle is directed downwards (vertically at a 90° angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with your thumb. This will send the medicine into the fatty tissue of the abdomen. Complete the injection 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 and firmly push the plunger to activate the safety system. The protective sleeve will automatically cover the needle. You will feel an audible “click” confirming activation of the protective sleeve. Now you can release the skin fold.

Changing the anticoagulant medicine

• Switching from CLEXANE/CLEXANE T to anticoagulants called vitamin K antagonists (such as warfarin)Your doctor will ask you to have a blood test called an INR and will tell you when to stop therapy with CLEXANE/CLEXANE T.
• Switching from anticoagulants called vitamin K antagonists (such as warfarin) to CLEXANE/CLEXANE TStop treatment with vitamin K antagonists. Your doctor will ask you to have a blood test called an INR and will tell you when to start therapy with CLEXANE/CLEXANE T.
• Switching from CLEXANE/CLEXANE T to treatment with direct oral anticoagulantsStop treatment with CLEXANE/CLEXANE T. Start taking the direct oral anticoagulant 0 to 2 hours before the time the next injection would have been given, then continue as usual.

• Switching from treatment with direct oral anticoagulants to CLEXANE/CLEXANE TStop 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 ingests CLEXANE/CLEXANE T, take them to the emergency room immediately.

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 helps you not to miss doses.

If you stop using CLEXANE/CLEXANE T
It is important that you continue to take injections of CLEXANE/CLEXANE T until your doctor decides to stop them. Stopping them on your own could be dangerous as a blood clot could form.
If you have any further questions about using this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Serious side effects
Stop using CLEXANE/CLEXANE Tand contact your doctor or
nurse immediatelyif you develop any sign of a serious allergic reaction (such as skin rash,
difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth,
throat or eyes).

Stop using enoxaparin and consult your doctor immediately if you notice any of the
following symptoms:

• A widespread red and scaly skin rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

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

Contact your doctor immediately:

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

You must inform your doctor immediately:

• If you experience signs of a blood vessel blockage by a clot, such as:
• painful cramps, redness, warmth or swelling of one of the legs - which are symptoms of deep vein thrombosis
• shortness of breath, chest pain, fainting or coughing up blood - which are symptoms of pulmonary embolism
• If you develop a painful rash of dark red spots under the skin that do not disappear 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 problem, with a low number of platelets.
• Pink spots on the skin. They are more likely to appear in the area where CLEXANE/CLEXANE T was injected.
• Skin rash (urticaria).
• Red and itchy skin.
• Bruising or pain at the injection site.
• Decreased number of red blood cells.
• High number of platelets in the blood.
• Headache.

Uncommon(may affect up to 1 in 100 people)

• Sudden and severe headache which may be a sign of bleeding in the brain.
• Pain and swelling in the stomach. This may be a symptom of bleeding in the stomach.
• Large, irregular-shaped red skin lesions with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and urine becoming darker in colour. This may be a liver problem.

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

• Severe allergic reaction. The signs of an allergic reaction can include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• Increased potassium in the blood. This is more likely in people with kidney problems or with diabetes. Your doctor may check the values with a blood test.
• Increased number of eosinophils in the blood. Your doctor may check the values with a blood test.
• Hair loss.
• Osteoporosis (a condition that makes bones more fragile) after prolonged use.
• Tingling, numbness and muscle weakness (especially in the lower part of the body) if you have had a spinal puncture or a spinal anaesthetic.
• Loss of bladder or bowel control (therefore unable to control when to go to the bathroom).
• Hard lump or nodule at the injection site.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects directly
through the national reporting system at:
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 at a temperature 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 break 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 in 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/CLEXANE T contains

• The active ingredient is enoxaparin sodium.
• Each ml contains 100 mg of 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 1.0 ml 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 package contents
CLEXANE/CLEXANE T is a clear, colorless or yellowish injectable solution in a pre-filled glass syringe (with or without 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 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 Authorisation Holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan

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 utca1.
Budapest, 1225 - Hungary
or
Sanofi-Aventis GmbH
Turm A, 29. OG, Wienerbergstraβe 11
1100Vienna - Austria
or
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst-Brüningstraße 50
65926 Frankfurt am Main
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria, France, Portugal: Lovenox.
Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Romania, Slovak Republic, 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 .

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

enoxaparin sodium

Read this leaflet carefully before you use 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 others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use CLEXANE T
• 3. How to use CLEXANE T
• 4. Possible side effects
• 6. How to store CLEXANE T
• 6. Contents of the pack and other information

1. What is CLEXANE T and what is it 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 prevent them from causing damage.
• 4) It blocks the formation of new blood clots.

What CLEXANE T is used for
CLEXANE T can be used for:

• Treating blood clots that are present
• Preventing the formation of blood clots in the following situations:
• before and after a surgical operation
• in the case of a short-term illness that involves a period of reduced mobility for a limited time
• Preventing the formation of blood clots in the presence of unstable angina (when not enough blood reaches the heart) or after a heart attack
• Avoiding the formation of blood clots in the tubes of the dialysis machine (used by people with severe kidney problems).

2. What you need to know before you use CLEXANE T

Do not use CLEXANE T if:

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

Warnings and precautions
CLEXANE T should not be substituted with other low molecular weight heparins such as nadroparin,
tinzaparin or dalteparin. These medicines are in fact not identical to each other 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 cells responsible for blood clotting (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 problems with the blood vessels in the eye caused by diabetes (so-called diabetic retinopathy)
• you have recently undergone eye or brain surgery
• you are elderly (over 65 years of age), especially if you are over 75 years of age
• you have kidney problems
• you have liver problems
• you are underweight or overweight
• you have high levels of potassium in your blood (values can be checked with a blood test)
• you are currently using medicines that affect bleeding (see section 2, “Other medicines and CLEXANE T”)
• you have problems with your spine or have undergone spinal surgery. If you are in one of the conditions listed above (or are not sure), contact your doctor or pharmacist before using CLEXANE T.

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

Tests and checks
You may need to have a blood test before starting to use this medicine and
regularly during its use, to check the level of cells responsible for blood clotting
(platelets) and the level of potassium in the blood.

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

Other medicines and CLEXANE T
Tell 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 blood clots (see section 3, “Changing the anticoagulant medicine”)
• dextran injection - used as a blood substitute
• ibuprofen, diclofenac, ketorolac or other medicines known as non-steroidal anti-inflammatory drugs 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 the level of potassium in the blood such as potassium salts, diuretics and some medicines for heart problems.

Surgery and anaesthesia
If you are going to have a spinal or lumbar puncture or surgery involving the use of
epidural or spinal anaesthetic, tell your doctor that you are using CLEXANE T.

Pregnancy and breastfeeding
If you are pregnant, suspect you may 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 greater risk of developing
blood clots. Your doctor will discuss this with you.
If you are breastfeeding or plan to breastfeed, ask your doctor
before taking this medicine.

Driving and operating machinery
CLEXANE T does not impair the ability to drive vehicles and operate machinery.
It is recommended that the healthcare operator records the trade name and batch number of the product that
you are using.

3. How to use CLEXANE T

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

Taking the medicine

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

How much medicine you will be given

• The doctor will decide how much CLEXANE T to administer to you. The quantity depends on the reason why it is being used.
• If you have kidney problems you may need to receive a lower amount of 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.
• The doctor will decide how long you will need to 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 to develop a clot. You may receive 2,000 IU (20 mg) or 4,000 IU (40 mg) of CLEXANE T daily.
• If you are to undergo surgery, the first injection will usually be administered 2 hours or 12 hours before the operation.
• In case of reduced mobility due to illness, you will normally be administered
• 4,000 IU (40 mg) of CLEXANE T daily.
• The doctor will decide how long you will need to receive CLEXANE T.

3. Prevention of blood clots in the presence of unstable angina or after a myocardial infarction

• CLEXANE T can be used for two different types of myocardial infarction.
• The amount of CLEXANE T administered depends on age and the type of myocardial infarction experienced.

Type NSTEMI myocardial infarction (myocardial infarction without ST segment elevation):

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

Type STEMI myocardial infarction (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 T will be administered to you as an injection into a vein.
• At the same time, you will also receive CLEXANE T as a subcutaneous injection (subcutaneous injection). The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Normally, your doctor will ask you to also take aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should receive CLEXANE T.

Type STEMI myocardial infarction 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 administered last, your doctor may decide to administer an additional dose of CLEXANE T before a percutaneous coronary intervention. The medicine will be injected into a vein.

4. Prevention of clot formation in the dialysis machine tubes

• The usual dose is 100 IU (1 mg) for each kilogram of body weight.
• CLEXANE T is added to the outgoing tube 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) for each kilogram of body weight, if necessary.

How to give yourself an injection of CLEXANE T
If you are able to administer CLEXANE T to yourself, the doctor or nurse will show you how to do it.
Do not attempt to give yourself the injection if you have not been trained on how to do so. If you are unsure about what to do, consult your doctor or nurse immediately. Correct execution of the injection under the skin (called a "subcutaneous injection") will help reduce pain and bruising at the injection site.

Before giving yourself an injection with CLEXANE T

• Collect the necessary items: syringe, alcohol swab or soap and water, and sharps container
• Check the expiration date of the medicine. Do not use it if the date has passed
• Check that the syringe is not damaged and that the medicine inside is a clear solution. If not, use another syringe
• Make sure you know how much medicine you need to inject
• Check the abdomen to see if the previous injection has caused redness, skin discoloration, swelling, leakage, or is still painful. If so, contact your doctor or nurse.

Instructions on how to inject CLEXANE T:
(Instructions for prefilled syringes without a safety system)
Preparation of the injection site

• 1) 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 flanks.
• Do not inject within 5 centimeters of the navel or around existing scars or bruises.
• Change the injection site between the left and right side of the abdomen, depending on the area where you made the injection last time.

• 2) Wash your hands. Clean (do not rub) the area where you will make the injection with an alcohol swab or soap and water.
• 3) Sit or lie down in a comfortable position so you are relaxed. Make sure you can see the area where you will make the injection. A reclining chair or a bed with pillows 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. This can lead to loss of medication.
• Once the cap is removed, avoid touching anything with the needle. This is 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, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove excess medicine by holding the syringe upside down (to keep the air bubble in the syringe) and expel the excess into a container.
• 4) A drop may appear on the tip of the needle. If this happens, remove the drop before giving the injection by tapping the syringe with the needle pointing downwards. You are now ready for the injection.

Injection

• 1) 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 form a fold in the skin.
• Make sure to maintain the skin fold throughout the injection.
• 2) Hold the syringe so that the needle is directed downwards (vertically at a 90° angle). Insert the entire length of the needle into the skin fold.

• 3) Press the plunger with your thumb. This will send the medicine into the fatty tissue of the abdomen. Complete the injection using all the medicine in the syringe.
• 4) Remove the needle from the injection site by pulling it straight out. Keep the needle away from yourself and others. You can now release the skin fold.

When you are finished

• 1) To avoid bruising, do not rub the area where you just gave the injection.
• 2) Dispose of the used syringe in the sharps container. Close the lid of the container tightly and place the container out of reach of children. When the container is full, dispose of it according to the instructions of your doctor or pharmacist.

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

(Instructions for prefilled syringes with automatic safety system type ERIS™)

• 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, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove excess medicine by holding the syringe upside down (to keep the air bubble in the syringe) and expel the excess into a container.
• 4) A drop may appear on the tip of the needle. If this happens, remove the drop before giving the injection by tapping the syringe with the needle pointing downwards. You are now ready for the injection.

Injection

• 1) 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 form a fold in the skin. Make sure to maintain the skin fold throughout the injection.
• 2) Hold the syringe so that the needle is directed downwards (vertically at a 90° angle). Insert the entire length of the needle into the skin fold.

When you are finished

• 1) To avoid bruising, do not rub the area where you just gave the injection.
• 2) Dispose of the used syringe in the sharps container. Close the lid of the container tightly and place the container out of reach of children. When the container is full, dispose of it according to the instructions of your doctor or pharmacist.

(Instructions for prefilled syringes with automatic safety system type PREVENTIS™)

• 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, you may need to adjust the dose in the syringe to match the prescribed dose. In this case, you can remove excess medicine by holding the syringe upside down (to keep the air bubble in the syringe) and expel the excess into a container.
• 4) A drop may appear on the tip of the needle. If this happens, remove the drop before giving the injection by tapping the syringe with the needle pointing downwards. You are now ready for the injection.

Injection

• 1) Hold the syringe in the hand you write with (like a pencil). With your other hand, gently pinch the clean area of your abdomen between your index finger and thumb to form a skin fold. Make sure to maintain the skin fold throughout the duration of the injection.
• 2) Hold the syringe so that the needle is directed downwards (vertically at a 90° angle). Insert the entire 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 abdomen. Complete the injection by using all of the medication 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, and firmly push the plunger to activate the safety system. The protective sleeve will automatically cover the needle. You will feel an audible “click” confirming activation of the protective sleeve. Now you can release the skin fold.

Changing the anticoagulant medication

• Switching from CLEXANE T to anticoagulants called vitamin K antagonists (such aswarfarin)Your doctor will ask you to have a blood test called an INR and will tell you when to stop therapy with CLEXANE T.
• Switching from anticoagulants called vitamin K antagonists (such as warfarin) toCLEXANE TStop treatment with vitamin K antagonists. Your doctor will ask you to have a blood test called an INR and will tell you when to start therapy with CLEXANE T.
• Switching from CLEXANE T to treatment with direct oral anticoagulantsStop treatment with CLEXANE T. Start taking the direct oral anticoagulant 0 to 2 hours before the time you would have had the next injection, then continue as usual.

• Switching from treatment with direct oral anticoagulants to CLEXANE TStop 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, tell your doctor, nurse or pharmacist immediately, even if you do not have any signs of problems. If a child accidentally injects or ingests CLEXANE T, take them to the emergency room immediately.

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 be sure not to miss a dose.

If you stop using CLEXANE T
It is important that you continue to give yourself CLEXANE T injections until your doctor decides to stop them. Stopping them on your own can be very dangerous as a blood clot may form.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Serious side effects
Stop using CLEXANE Tand contact your doctor or nurse immediatelyif
you develop any sign of a serious allergic reaction (such as skin rash, difficulty
breathing or swallowing, swelling of the face, lips, tongue, oral cavity, throat or
eyes).

Stop using enoxaparin and consult your doctor immediately if you notice any of the
following symptoms:

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

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

Contact your doctor immediately:

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

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

You must inform your doctor immediately:

• If you experience signs of a blood vessel blockage by a clot, such as:
• painful cramps, redness, warmth or swelling of one of the legs - which represent the symptoms of deep vein thrombosis
• shortness of breath, chest pain, fainting or coughing up blood - which represent the symptoms of pulmonary embolism
• If you experience a painful skin rash with dark red spots under the skin that do not disappear 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 problem, with a low number of platelets.
• Pink spots on the skin. Their appearance is more likely in the area where CLEXANE T was injected.
• Skin rash (hives, urticaria).
• Red and itchy skin.
• Bruising or pain at the injection site.
• Decreased number of red blood cells.
• High number of platelets in the blood.
• Headache.

Uncommon(may affect up to 1 in 100 people)

• Sudden and severe headache which may be a sign of bleeding in the brain.
• Pain and swelling in the stomach. This may be a symptom of bleeding in the stomach.
• Large, irregular-shaped red skin lesions with or without blisters.
• Skin irritation (local irritation).
• Yellowing of the skin or eyes and urine becoming darker in color. This may be a liver problem.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist or nurse. You can also report side effects directly
through 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 at a temperature 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 break 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 in 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 ingredient is enoxaparin sodium.
• Each ml contains 150 mg of enoxaparin sodium equivalent to 15,000 IU of anti-Xa activity. Each prefilled syringe of 0.8 ml contains 12,000 IU (120 mg) of enoxaparin sodium. Each prefilled syringe of 1.0 ml contains 15,000 IU (150 mg) of enoxaparin sodium
• The other component is water for injections.

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

Marketing authorisation holder
Sanofi S.r.l. - Viale L. Bodio, 37/B - Milan

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 utca1.
Budapest, 1225 - Hungary
or
Sanofi-Aventis GmbH
Turm A, 29. OG, Wienerbergstraβe 11
1100 Vienna – Austria
Or
Sanofi Winthrop Industrie
1051 Boulevard Industriel
76580 Le Trait
France
Or
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst-Brüningstraβe 50
65926 Francoforte sul Meno
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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.

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