Enoxaparin sodium Ledraxen

PATIENT INFORMATION LEAFLET

Patient Information Leaflet included with the packaging: patient information

Enoxaparin sodium Ledraxen, 2000 IU (20 mg)/0.2 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 4000 IU (40 mg)/0.4 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 6000 IU (60 mg)/0.6 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 8000 IU (80 mg)/0.8 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium Ledraxen, 10,000 IU (100 mg)/1 mL, solution for injection
in a pre-filled syringe
Enoxaparin sodium
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See section 4 for how to report side effects.

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Enoxaparin sodium Ledraxen and what is it used for
• 2. Important information before using Enoxaparin sodium Ledraxen
• 3. How to use Enoxaparin sodium Ledraxen
• 4. Possible side effects
• 5. How to store Enoxaparin sodium Ledraxen
• 6. Contents of the packaging and other information

1. What is Enoxaparin sodium Ledraxen and what is it used for

Enoxaparin sodium Ledraxen contains the active substance enoxaparin sodium. It belongs to a group of medicines called low molecular weight heparins or LMWHs.
Enoxaparin sodium Ledraxen works in two ways:

• 1) It prevents the growth of existing blood clots. This helps the body to dissolve existing blood clots, so they are no longer harmful.
• 2) It prevents the formation of new blood clots in the patient's blood.

Enoxaparin sodium Ledraxen can be used for:

• Treating blood clots that are already present in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following cases: before and after surgery, or during a short-term illness when the patient will not be able to move for a period of time

in patients who have developed blood clots in the circulating blood due to cancer, to further prevent the formation of new blood clots

• Preventing the formation of blood clots in unstable angina (when insufficient blood is supplied to the heart muscle) or after a heart attack
• Preventing the formation of blood clots in the tubes of a dialyzer (used in people with severe kidney function disorders).

2. Important information before using Enoxaparin sodium Ledraxen

Do not use Enoxaparin sodium Ledraxen if:

• the patient is 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. Symptoms of an allergic reaction may include: rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes.
• the patient has had a reaction to heparin that caused a significant decrease in the number of blood cells responsible for blood clotting (platelets) in the last 100 days.
• there are antibodies against enoxaparin in the patient's blood.
• the patient has severe bleeding or a medical condition associated with an increased risk of bleeding, such as: stomach ulcers, recent brain or eye surgery, or recent hemorrhagic stroke.
• the patient is using Enoxaparin sodium Ledraxen to treat blood clots, and a lumbar puncture or surgical procedure under spinal or epidural anesthesia is planned within 24 hours.

Warnings and precautions

Enoxaparin sodium Ledraxen should not be used interchangeably with other low molecular weight heparins. This is because they are not exactly the same, differ in activity, and have different instructions for use.
Before starting to use Enoxaparin sodium Ledraxen, you should discuss it with your doctor or pharmacist if:

• the patient has ever had a reaction to heparin that caused a large decrease in the number of blood cells responsible for blood clotting (platelets)
• the patient has had a heart valve replaced
• the patient has endocarditis (infection of the membrane lining the heart)
• the patient has a history of stomach ulcers
• the patient has recently had a stroke
• the patient has high blood pressure
• the patient has diabetes or has vascular disorders in the eyes caused by diabetes (so-called diabetic retinopathy)
• the patient has recently had eye or brain surgery
• the patient is elderly (over 65 years), especially if they are over 75 years old
• the patient has kidney disease
• the patient has liver disease
• the patient is underweight or overweight
• the patient has an increased level of potassium in the blood (which can be checked with a blood test)
• the patient is currently taking medications that may cause bleeding (see section 2 "Enoxaparin sodium Ledraxen and other medicines").
• the patient has spinal problems or has had spinal surgery.

If any of the above situations apply to the patient or the patient has doubts, they should discuss it with their doctor or pharmacist before starting to use Enoxaparin sodium Ledraxen.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

Tests and monitoring

Before starting to use this medicine and periodically during its use, the patient may undergo a blood test to check the number of platelets responsible for blood clotting and the level of potassium in the blood.

Use in children and adolescents

The safety and efficacy of Enoxaparin sodium Ledraxen have not been evaluated in children and adolescents.

Enoxaparin sodium Ledraxen and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking, have recently taken, or plan to take.

• warfarin - a medicine 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 "Change of anticoagulant medicine")
• dextran injections - used as a blood substitute
• ibuprofen, diclofenac, ketorolac, or other non-steroidal anti-inflammatory medicines 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, or certain heart medicines.

Surgical procedures and anesthetics

If the patient is scheduled to have a lumbar puncture or surgical procedure under spinal or epidural anesthesia, they should inform their doctor that they are using Enoxaparin sodium Ledraxen.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
In pregnant women with a mechanical heart valve, there may be an increased risk of blood clots. The doctor should discuss this with the patient.
Women who are breastfeeding or plan to breastfeed should consult their doctor before starting to use this medicine.

Use in children and adolescents

The safety and efficacy of Enoxaparin sodium Ledraxen have not been evaluated in children and adolescents.

Driving and using machines

Enoxaparin sodium Ledraxen does not affect the ability to drive or use machines.
It is recommended that the doctor documents the trade name and batch number of the medicinal product used.

3. How to use Enoxaparin sodium Ledraxen

This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Taking the medicine

• Enoxaparin sodium Ledraxen will usually be administered to the patient by a doctor or nurse. This is because it requires injection.
• Enoxaparin sodium Ledraxen is usually administered by subcutaneous injection.
• Enoxaparin sodium Ledraxen may be administered by intravenous injection after certain types of heart attack or after surgery.
• Enoxaparin sodium Ledraxen may be introduced into the dialysis tube returning blood from the body (into the so-called arterial line) at the beginning of the dialysis session.
• Enoxaparin sodium Ledraxen must not be administered by intramuscular injection.

Amount of medicine to be administered

• The doctor will decide what dose of Enoxaparin sodium Ledraxen the patient should take. This depends on the reason for using the medicine.
• In patients with kidney disease, the patient may receive a lower dose of Enoxaparin sodium Ledraxen.
• 1) Treatment of blood clots present in the patient's 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.
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen.
• 2) Prevention of blood clot formation in the patient's blood during surgery or during a period of limited mobility due to illness
• The dose depends on the patient's risk of blood clot formation. The patient will receive Enoxaparin sodium Ledraxen at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) once daily.
• The first injection is usually performed 2 hours or 12 hours before surgery.
• If the patient has limited mobility due to illness, they will usually receive Enoxaparin sodium Ledraxen at a dose of 4000 IU (40 mg) once daily.
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen.
• 3) Prevention of blood clot formation in patients with unstable angina or after a heart attackEnoxaparin sodium Ledraxen can be used in two different types of heart attack. The dose of Enoxaparin sodium Ledraxen will depend on the patient's age and the type of heart attack they had.

Non-ST-segment elevation myocardial infarction (NSTEMI) (heart attack without ST-segment elevation):

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also take aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen. ST-segment elevation myocardial infarction (STEMI) (heart attack with ST-segment elevation) in patients under 75 years of age:
• The initial dose of Enoxaparin sodium Ledraxen is 3000 IU (30 mg) administered intravenously.
• At the same time, Enoxaparin sodium Ledraxen will also be administered subcutaneously. The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• The doctor will usually recommend that the patient also take aspirin (acetylsalicylic acid).
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen. ST-segment elevation myocardial infarction (STEMI) in patients 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 Enoxaparin sodium Ledraxen in the first two doses is 7500 IU (75 mg).
• The doctor will decide how long the patient should receive Enoxaparin sodium Ledraxen.

Patient undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Enoxaparin sodium Ledraxen was administered, the doctor may decide to administer an additional dose of Enoxaparin sodium Ledraxen before the PCI procedure. The medicine will be administered intravenously.

• 4) Prevention of blood clot formation in the dialyzer tubes
• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Enoxaparin sodium Ledraxen is injected into the tube returning blood from the body (into the so-called arterial line) at the beginning of the dialysis session. This dose is usually sufficient for a 4-hour dialysis session. However, if necessary, the doctor may administer an additional dose of 50 IU to 100 IU (0.5 to 1 mg) per kilogram of body weight. Self-administration of Enoxaparin sodium Ledraxen. If the patient is able to self-administer Enoxaparin sodium Ledraxen, the doctor or nurse will demonstrate how to do it. The patient should not attempt to self-administer the medicine if they have not been trained to do so. If the patient has any doubts about how to do it, they should immediately consult their doctor or nurse. Administering the injection properly under the skin (so-called subcutaneous injection) can reduce pain and bruising at the injection site. Before self-administering Enoxaparin sodium Ledraxen
• Prepare all the necessary items: syringe, alcohol swab, soap, and water, and a container for medical waste.
• Check the expiration date on the packaging. Do not use the medicine after the expiration date.
• Check if the syringe is damaged and if the liquid is clear. If not, use another syringe.
• Make sure what dose is to be administered.
• Examine the abdomen to check if the last injection has caused redness, discoloration, swelling, discharge, or if it is still painful. If so, consult a doctor or nurse.

Instructions for syringes without a safety system

• Preparing the injection site: Before administering the injection, wash your hands and dry them. Use a swab to clean (without rubbing) the chosen injection site. A different area of the abdomen should be chosen for each injection.
• Remove the protective cap from the needle. It is possible for a drop to form at the tip of the needle. In this case, remove the drop by tapping the syringe body (with the needle facing down).
• Administer the injection: The pre-filled syringe is ready for immediate use. Choose a site on the right or left side of the abdomen. It should be at least 5 cm away from the navel and towards the side. Hold the syringe so that the needle is facing down (at a 90° angle), into the thickness of the skin fold created by pinching the skin between the thumb and index finger of the operator. The fold should be held throughout the injection.
• Immediately dispose of the syringe in a suitable container.

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

Instructions for syringes with a safety system

• Preparing the injection site: Before administering the injection, wash your hands and dry them. Use a swab to clean (without rubbing) the chosen injection site. A different area of the abdomen should be chosen for each injection.
• First, bend the lock to the side by about 90 degrees. Note: Do not remove the cap before bending the lock.
• Remove the protective cap from the needle. It is possible for a drop to form at the tip of the needle. In this case, remove the drop by tapping the pre-filled syringe body (with the needle facing down).

• Administer the injection: The pre-filled syringe is ready for immediate use. Choose a site on the right or left side of the abdomen. It should be at least 5 cm away from the navel and towards the side. Hold the syringe so that the needle is facing down (at a 90° angle), into the thickness of the skin fold created by pinching the skin between the thumb and index finger of the operator. The fold should be held throughout the injection.

• Secure the needle lock: Using one hand, place the lock on a hard, stable surface. Important: Do not use your finger to hold the needle in the lock. Then press the lock. Bend the lock until the needle clicks into the plastic part.

• Immediately dispose of the syringe in a suitable container.

After administering the injection

• 1) To avoid bruising, do not rub the injection site after administering the injection.
• 2) Dispose of the used syringe in a container for medical waste. Close the container and store it in a place that is out of sight and reach of children. If the container is full, dispose of it according to the doctor's or pharmacist's instructions.

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

Change of anticoagulant medicine

• Change from Enoxaparin sodium Ledraxen to medicines that thin the blood, called vitamin K antagonists (such as warfarin)The doctor will recommend that the patient undergo blood tests to determine the INR ratio and inform the patient when to stop taking Enoxaparin sodium Ledraxen.
• Change from medicines that thin the blood, called vitamin K antagonists (such as warfarin), to Enoxaparin sodium LedraxenStop taking the vitamin K antagonist medicine. The doctor will recommend that the patient undergo blood tests to determine the INR ratio and inform the patient when to start taking Enoxaparin sodium Ledraxen.
• Change from Enoxaparin sodium Ledraxen to direct oral anticoagulantsStop taking Enoxaparin sodium Ledraxen. Then start taking the direct oral anticoagulant 0 to 2 hours before the scheduled time of the next injection; and then continue taking the medicine as usual.
• Change from direct oral anticoagulant to Enoxaparin sodium LedraxenStop taking the direct oral anticoagulant. Treatment with Enoxaparin sodium Ledraxen can be started 12 hours after the last dose of the direct oral anticoagulant.

Using a higher dose of Enoxaparin sodium Ledraxen than recommended

If the patient thinks they have used too much or too little Enoxaparin sodium Ledraxen, they should immediately inform their doctor, pharmacist, or nurse, even if they do not experience any symptoms. In case of accidental injection or ingestion of Enoxaparin sodium Ledraxen by a child, immediately go to the hospital emergency department.

Missing a dose of Enoxaparin sodium Ledraxen

If a dose of the medicine is missed, it should be taken as soon as possible. Do not take a double dose to make up for the missed dose. Keeping a diary helps to ensure that no dose of the medicine is missed.

Stopping the use of Enoxaparin sodium Ledraxen

It is important to continue administering Enoxaparin sodium Ledraxen until the doctor recommends stopping it. If treatment is stopped, a blood clot may form, which can be very dangerous.
If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Enoxaparin sodium Ledraxen can cause side effects, although not everybody gets them.

Severe side effects

Stop using Enoxaparin sodium Ledraxen and consult your doctor or nurse immediately if you experience symptoms of a severe allergic reaction (such as rash, difficulty breathing or swallowing, swelling of the face, lips, tongue, mouth, throat, or eyes).
If you experience any of the following symptoms, stop using Enoxaparin sodium Ledraxen and seek medical attention immediately:

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

Like other similar medicines (used to reduce blood clotting), Enoxaparin sodium Ledraxen may cause bleeding. This can be life-threatening. In some cases, bleeding may not be immediately visible.

You should immediately consult your doctor if:

• the patient experiences any bleeding that does not stop on its own
• the patient experiences signs of excessive bleeding, such as weakness, fatigue, paleness, dizziness with headaches, or unexplained swelling. The doctor may decide to monitor the patient more closely or change the medicine.

You should immediately consult your doctor:

• if the patient experiences any signs of a blood clot in a blood vessel, such as: cramp-like pain, redness, increased warmth, or swelling in one of the lower limbs - these are symptoms of deep vein thrombosis;

or
shortness of breath, chest pain, fainting, or coughing up blood - these are symptoms of pulmonary embolism.

• if the patient experiences painful rash or dark red spots under the skin that do not disappear when pressed. The doctor may order blood tests to check the platelet count.

Other side effects:

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

• bleeding;
• increased activity of liver enzymes. Common (may affect up to 1 in 10 people):
• increased tendency to bruise - this may be due to a decrease in the number of platelets;
• pink spots on the skin - these changes are more likely to occur at the injection sites of Enoxaparin sodium Ledraxen;
• skin rash (hives);
• itching, redness of the skin;
• bruising or pain at the injection site;
• decreased number of red blood cells;
• increased number of platelets;
• headache. Uncommon (may affect up to 1 in 100 people):
• sudden severe headache - this may be a sign of bleeding in the brain;
• feeling of tenderness and swelling in the stomach - this may be a sign of bleeding in the stomach;
• large, red, irregularly shaped skin changes with blisters or without blisters;
• skin irritation (local irritation);
• the patient may notice yellowing of the skin or eyes and darker urine
• this may indicate liver disease. Rare (may affect up to 1 in 1000 people):
• severe allergic reaction - symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
• increased level of potassium in the blood - this is more likely to occur in people with kidney disease or diabetes; The doctor may check this with a blood test;
• increased number of eosinophils in the blood - the doctor may check this with a blood test;
• hair loss;
• osteoporosis (a condition in which bones are more prone to fractures) after long-term use of the medicine;
• tingling, numbness, and weakness of the muscles (especially in the lower part of the body) after a lumbar puncture or spinal or epidural anesthesia;
• loss of control over the bladder or bowels (a condition in which the patient is unable to control when they need to go to the toilet);
• hardening or a lump at the injection site.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Enoxaparin sodium Ledraxen

Do not store above 25°C.
Do not freeze.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Do not use this medicine if you notice any changes in the appearance of the solution.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Enoxaparin sodium Ledraxen contains

2000 IU (20 mg)/0.2 mL solution for injection:

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe with a capacity of 0.2 mL contains 2000 IU of anti-Xa activity (which corresponds to 20 mg) of enoxaparin sodium.
• The other ingredient is water for injection.

4000 IU (40 mg)/0.4 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe with a capacity of 0.4 mL contains 4000 IU of anti-Xa activity (which corresponds to 40 mg) of enoxaparin sodium.
• The other ingredient is water for injection.

6000 IU (60 mg)/0.6 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe with a capacity of 0.6 mL contains 6000 IU of anti-Xa activity (which corresponds to 60 mg) of enoxaparin sodium.
• The other ingredient is water for injection.

8000 IU (80 mg)/0.8 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe with a capacity of 0.8 mL contains 8000 IU of anti-Xa activity (which corresponds to 80 mg) of enoxaparin sodium.
• The other ingredient is water for injection.

10,000 IU (100 mg)/1 mL solution for injection

• The active substance is enoxaparin sodium. Each mL contains 100 mg of enoxaparin sodium. Each pre-filled syringe with a capacity of 1.0 mL contains 10,000 IU of anti-Xa activity (which corresponds to 100 mg) of enoxaparin sodium.
• The other ingredient is water for injection.

What Enoxaparin sodium Ledraxen looks like and contents of the packaging

2000 IU (20 mg)/0.2 mL solution for injection:
Colorless or pale yellow, clear liquid
0.2 mL of solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging containing 1, 2, 6, 10, 20, or 50 pre-filled syringes.
4000 IU (40 mg)/0.4 mL solution for injection:
Colorless or pale yellow, clear liquid
0.4 mL of solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging containing 1, 2, 6, 10, 20, 30, or 50 pre-filled syringes.
6000 IU (60 mg)/0.6 mL solution for injection:
Colorless or pale yellow, clear liquid
0.6 mL of solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging containing 1, 2, 6, 10, 12, 20, 24, 30, or 50 pre-filled syringes.
8000 IU (80 mg)/0.8 mL solution for injection:
Colorless or pale yellow, clear liquid
0.8 mL of solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging containing 1, 2, 6, 10, 12, 20, 24, 30, or 50 pre-filled syringes.
10,000 IU (100 mg)/1 mL solution for injection:
Colorless or pale yellow, clear liquid
1 mL of solution in a syringe made of neutral glass type I with a fixed needle closed with a rubber plug and a piston made of PP, in a cardboard box.
Packaging containing 1, 2, 6, 10, 12, 20, 24, or 30 pre-filled syringes.
For pre-filled syringes with a capacity of 0.2 mL and 0.4 mL, there is no graduation on the syringe.
For pre-filled syringes with a capacity of 0.6 mL, 0.8 mL, and 1 mL, the syringes are graduated.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Venipharm
4 Bureaux de la Colline
92210 Saint-Cloud
France
+33 1 47 11 0447
venipharm@venipharm.com

Importer

Centre Spécialités Pharmaceutiques
ZAC des Suzots
35 rue de la Chapelle
63450 Saint-Amant Tallende
France

This medicine has been authorized for marketing in the EEA member states under the following names:

Austria: Enoxaparin Ledraxen
Cyprus: Ledraxen
Czech Republic: Enoxaparin sodium Ledraxen
Finland: Enoxaparin Ledraxen
Croatia: Enoksaparin sodium Ledraxen
United Kingdom (Northern Ireland): Enoxaparin Ledraxen
Lithuania: Enoxaparin sodium Ledraxen
Latvia: Enoxaparin sodium Ledraxen
Norway: Enoxaparin Ledraxen
Poland: Enoxaparin sodium Ledraxen
Portugal: Enoxaparin sodium Ledraxen
Slovakia: Ledraxen
Slovenia: Enoksaparin Ledraxen
Germany: Enoxaparin Ledraxen
France: Enoxaparine Arrow
Sweden: Enoxaparin Ledraxen
Spain: Enoxaparina Ledraxen

Date of last revision of the leaflet: 06/2023

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Website: https://smz.ezdrowie.gov.pl