Enoxaparin sodium ledraxen

Package leaflet: Information for the patient

Enoxaparin sodium Ledraxen, 2000 IU (20 mg)/0.2 mL, solution for injection
in pre-filled syringe
Enoxaparin sodium Ledraxen, 4000 IU (40 mg)/0.4 mL, solution for injection
in pre-filled syringe
Enoxaparin sodium Ledraxen, 6000 IU (60 mg)/0.6 mL, solution for injection
in pre-filled syringe
Enoxaparin sodium Ledraxen, 8000 IU (80 mg)/0.8 mL, solution for injection
in pre-filled syringe
Enoxaparin sodium Ledraxen, 10,000 IU (100 mg)/1 mL, solution for injection
in pre-filled syringe
Enoxaparin sodium
This medicinal product will be subject to additional monitoring. This will allow rapid identification
of new safety information. You can also help by reporting any side effects that occur after using
the medicine. For information on how to report side effects – see section 4.
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Enoxaparin sodium Ledraxen is and what it is 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 pack and other information

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

Enoxaparin sodium Ledraxen contains the active substance called enoxaparin sodium. It belongs
to a group of medicines known as low molecular weight heparins (LMWH).
Enoxaparin sodium Ledraxen works in two ways:

1. It prevents existing blood clots from growing larger. 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 may be used for:

• Treating existing blood clots in the patient's blood.
• Preventing the formation of blood clots in the patient's blood in the following situations:
  • before and after surgical procedures
  • during short-term illness when the patient is unable to move for a period of time
  • in patients who have developed blood clots due to cancer, to further prevent the formation of new clots
• Preventing clot formation in unstable angina (when insufficient blood is supplied to the heart muscle) or after a heart attack
• Preventing clot formation in the dialysis circuit (used in patients with severe kidney dysfunction).

2. Important information before using Enoxaparin sodium Ledraxen

Do not use Enoxaparin sodium Ledraxen if:

• the patient is allergic to: o enoxaparin sodium or any of the other ingredients of this medicine (listed in section 6) o heparin or other low molecular weight heparins, such as nadroparin, tinzaparin or dalteparin. 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 drop in the number of blood cells responsible for blood clotting (platelets) within the last 100 days.
• the patient has antibodies against enoxaparin in the blood.
• the patient has active bleeding or a medical condition associated with an increased risk of bleeding, for example: o stomach ulcers, recent surgery on the brain or eyes, or recent haemorrhagic stroke.
• the patient is being treated with Enoxaparin sodium Ledraxen for blood clots, and within the next 24 hours is scheduled for: o lumbar puncture o surgical procedure under spinal or epidural anaesthesia. Enoxaparin sodium Ledraxen must not be used in the patients listed above. If in doubt, discuss this with your doctor or pharmacist before starting treatment with Enoxaparin sodium Ledraxen.

Warnings and precautions
Enoxaparin sodium Ledraxen must not be used interchangeably with other low molecular weight
heparins. This is because they are not exactly the same and differ in activity and dosing
instructions.
Before starting treatment with Enoxaparin sodium Ledraxen, discuss this with your doctor or
pharmacist if:

• the patient has ever had a reaction to heparin causing a major drop in the number of blood cells responsible for blood clotting (platelets)
• the patient has a heart valve implant
• the patient has endocarditis (infection of the inner lining of 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 diabetic eye disease affecting blood vessels in the eye (so-called diabetic retinopathy)
• the patient has recently undergone eye or brain surgery
• the patient is elderly (over 65 years of age), particularly if over 75 years of age
• the patient has kidney disease
• the patient has liver disease
• the patient is underweight or overweight
• the patient has elevated potassium levels in the blood (this can be checked with a laboratory 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 undergone spinal surgery.

If any of the above conditions apply to the patient or if the patient has any doubts, discuss this with
your doctor or pharmacist before starting treatment with Enoxaparin sodium Ledraxen.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered “sodium-free”.
Monitoring and tests
Before starting treatment with this medicine and periodically during treatment, blood tests may be
performed to monitor the number of platelets (blood cells responsible for blood clotting) and the
patient’s blood potassium levels.
Use in children and adolescents
The safety and efficacy of Enoxaparin sodium Ledraxen in children and adolescents have not been established.
Enoxaparin sodium Ledraxen and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines the patient plans 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 “Switching anticoagulant medication”)
• dextran injections – used as a blood volume expander
• 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 used for heart conditions.

Surgical procedures and anaesthetics
If the patient is scheduled for a lumbar puncture or a surgical procedure under epidural or
spinal anaesthesia, inform the doctor that the patient is using Enoxaparin sodium Ledraxen.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Women who are pregnant and have a mechanical heart valve may be at increased risk of blood
clots. The doctor should discuss this issue with the patient.
Women who are breastfeeding or intend to breastfeed should seek medical advice before starting
treatment with this medicine.
Use in children and adolescents
The safety and efficacy of Enoxaparin sodium Ledraxen in children and adolescents have not been established.
Driving and operating machinery
Enoxaparin sodium Ledraxen has no effect on the ability to drive or operate machinery.
It is recommended that the doctor document the brand name and batch number of the medicinal product used.

3. How to use Enoxaparin sodium Ledraxen

This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts,
please consult your doctor or pharmacist.
Taking the medicine

• Enoxaparin sodium Ledraxen is usually administered to the patient by a doctor or nurse. This is because it requires injection.
• Enoxaparin sodium Ledraxen is usually given as subcutaneous injections.
• Enoxaparin sodium Ledraxen may be administered as an intravenous injection following certain types of heart attack or after surgery.
• Enoxaparin sodium Ledraxen may be introduced into the dialysis tubing carrying blood away from the body (into the so-called arterial line) at the beginning of a dialysis session.
• Enoxaparin sodium Ledraxen must not be administered by intramuscular injection. Dose of medicine to be administered
• Your doctor will decide how much Enoxaparin sodium Ledraxen you should receive. The dose depends on the reason for using the medicine.
• If you have kidney disease, you 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.
• Your doctor will decide how long you should continue receiving Enoxaparin sodium Ledraxen. 2) Prevention of blood clot formation during surgical procedures
  or during periods of limited mobility due to illness
• The dose depends on the individual patient's risk of clot formation. You will receive Enoxaparin sodium Ledraxen at a dose of 2000 IU (20 mg) or 4000 IU (40 mg) daily.
• Prior to planned surgery, the first injection is usually given 2 hours or 12 hours before the procedure.
• If you have limited mobility due to illness, you will usually receive Enoxaparin sodium Ledraxen at a dose of 4000 IU (40 mg) daily.
• Your doctor will decide how long you should continue receiving Enoxaparin sodium Ledraxen. 3) Prevention of blood clots in patients with unstable angina or after
  myocardial infarction Enoxaparin 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 that occurred.

NSTEMI-type heart attack (non-ST-elevation myocardial infarction):

• The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
• Your doctor will usually also recommend taking aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should continue receiving Enoxaparin sodium Ledraxen. STEMI-type heart attack (ST-elevation myocardial infarction) in patients under 75 years of age:
• An initial intravenous dose of Enoxaparin sodium Ledraxen of 3000 IU (30 mg) will be administered.
• Simultaneously, Enoxaparin sodium Ledraxen will also be given 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 recommend taking aspirin (acetylsalicylic acid).
• Your doctor will decide how long you should continue receiving Enoxaparin sodium Ledraxen. STEMI-type myocardial infarction in patients aged 75 years 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 for the first two doses is 7500 IU (75 mg).
• Your doctor will decide how long you should continue receiving Enoxaparin sodium Ledraxen.

Patients undergoing percutaneous coronary intervention (PCI):
Depending on when the last dose of Enoxaparin sodium Ledraxen was administered, your doctor
may decide to administer an additional dose of Enoxaparin sodium Ledraxen before the
percutaneous coronary intervention procedure. The medicine will then be given by intravenous
injection.
4) Prevention of blood clot formation in dialyzer tubing

• The usual dose is 100 IU (1 mg) per kilogram of body weight.
• Enoxaparin sodium Ledraxen is injected into the tubing carrying blood away from the body (into the so-called arterial line) at the start of the dialysis session. This dose is usually sufficient for a 4-hour dialysis session. However, if necessary, your 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 injections
  If you are able to self-administer Enoxaparin sodium Ledraxen injections, your doctor or nurse will demonstrate how to do so. Do not attempt to inject yourself unless you have been properly trained. If you have any doubts about how to perform the injection, consult your doctor or nurse immediately. Correct subcutaneous injection technique (known as "subcutaneous injection") may reduce pain and bruising at the injection site. Before self-injecting Enoxaparin sodium Ledraxen:
• Prepare all necessary supplies: syringe, alcohol swab or soap and water, and a sharps disposal container.
• Check the expiry date on the packaging. Do not use the medicine after the expiry date.
• Check that the syringe is undamaged and that the liquid is clear. If not, use another syringe.
• Confirm the correct dose to be administered.
• Examine the abdominal area to check whether the previous injection caused redness, skin discoloration, swelling, leakage, or if it is still painful. If so, consult your doctor or nurse.

Instructions for syringes without a safety device

• Preparing the injection site: Wash and dry your hands before administering the injection. Use a swab to clean the selected injection site (avoid rubbing). For each injection, choose a different area of the abdomen.
• Remove the protective needle cap. A drop of liquid may appear at the tip of the needle. If so, gently tap the barrel of the syringe (with the needle pointing downward) to remove the drop before injection.

• Administer the injection: The pre-filled syringe is ready for immediate use. Choose a site on the right or left side of the abdomen, at least 5 cm away from the navel and toward the side. Hold the syringe so that the needle points downward (vertically at a 90° angle) into a skin fold created by pinching the skin between your thumb and index finger. Maintain the skin fold throughout the injection.

• Immediately dispose of the syringe in an appropriate container.

Any unused portions of the medicinal product or waste materials must be disposed of in accordance with
local regulations.
Instructions for syringes with a safety device

• Preparing the injection site: Wash and dry your hands before administering the injection. Use a swab to clean the selected injection site (avoid rubbing). For each injection, choose a different area of the abdomen.
• First, bend the safety guard sideways by approximately 90 degrees. Caution: Do not remove the needle cap before bending the safety guard.

• Remove the protective needle cap. A drop of liquid may appear at the tip of the needle. If so, gently tap the barrel of the pre-filled syringe (with the needle pointing downward) to remove the drop before injection.

• Administer the injection: The pre-filled syringe is ready for immediate use. Choose a site on the right or left side of the abdomen, at least 5 cm away from the navel and toward the side. Hold the syringe so that the needle points downward (vertically at a 90° angle) into a skin fold created by pinching the skin between your thumb and index finger. Maintain the skin fold throughout the injection.

• Engage the needle safety guard: Using one hand, place the safety guard against a hard, stable surface. Important: Do not use your finger to hold the needle in place within the guard. Then press down on the guard. Continue pressing until the needle audibly clicks into the plastic component.

• Immediately dispose of the syringe in an appropriate container.

After the injection

1. To avoid bruising, do not rub the injection site after administration.
2. Dispose of the used syringe in a sharps disposal container. Close the container lid and store it out of sight and out of reach of children. If the container is full, dispose of it according to your doctor's or pharmacist's instructions.
   Any unused portions of the medicinal product or waste materials must be disposed of in accordance with
   local regulations.
   Switching anticoagulant medicines

• Switching from Enoxaparin sodium Ledraxen to blood-thinning medicines known as vitamin K antagonists (such as warfarin)
  Your doctor will order blood tests to monitor your INR and will inform you when to stop taking Enoxaparin sodium Ledraxen.
• Switching from vitamin K antagonist medicines (such as warfarin) to Enoxaparin sodium Ledraxen
  Discontinue the vitamin K antagonist medicine. Your doctor will order blood tests to monitor your INR and will inform you when to start taking Enoxaparin sodium Ledraxen.
• Switching from Enoxaparin sodium Ledraxen to direct oral anticoagulants
  Stop taking Enoxaparin sodium Ledraxen. Begin taking the direct oral anticoagulant 0 to 2 hours before the scheduled time of the next injection; then continue taking it as usual.
• Switching from a direct oral anticoagulant to Enoxaparin sodium Ledraxen
  Stop taking the direct oral anticoagulant. Treatment with Enoxaparin sodium Ledraxen may begin only 12 hours after the last dose of the direct oral anticoagulant.

Use of a higher than recommended dose of Enoxaparin sodium Ledraxen
If you think you have taken too much or too little Enoxaparin sodium
Ledraxen, contact your doctor, pharmacist, or nurse immediately, even if
you do not have symptoms of any problems. In case of accidental injection or
ingestion of Enoxaparin sodium Ledraxen by a child, seek immediate medical attention at the nearest hospital emergency department.
Missed dose of Enoxaparin sodium Ledraxen
If you miss a dose, take it as soon as possible. Do not take a double dose to make up for a missed dose. Keeping a diary can help ensure you do not miss a dose.
Stopping Enoxaparin sodium Ledraxen treatment
It is important to continue Enoxaparin sodium Ledraxen injections until your doctor advises you to stop. Stopping treatment may result in a blood clot forming, which could be very dangerous.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Serious adverse effects
Stop using Enoxaparin sodium Ledraxen and seek immediate medical advice from a doctor or nurse 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 any of the following symptoms occur, stop using enoxaparin and seek immediate medical help:

• Red, scaly, widespread rash with lumps 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 could potentially be life-threatening. In some cases, bleeding may not be immediately visible.
Seek immediate medical advice if:

• the patient experiences any bleeding that does not stop spontaneously;
• the patient shows signs of excessive bleeding such as weakness, fatigue, paleness, dizziness with headache or unexplained swelling. The doctor may decide to observe the patient more closely or change the treatment.

Seek immediate medical advice:

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

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

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

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

• bleeding;
• increased liver enzyme activity.
  Common (may affect up to 1 in 10 people):
• increased tendency to bruising – this may be due to reduced platelet count;
• pink skin spots – these changes are more likely at the injection sites of Enoxaparin sodium Ledraxen;
• skin rash (urticaria);
• itchy, red 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 indicate bleeding into the brain;
• sensation of tenderness and swelling in the stomach – this may indicate gastrointestinal bleeding;
• large, red skin lesions of irregular shape, with or without blisters;
• skin irritation (local irritation);
• the patient may notice yellowing of the skin or eyes and darker urine colour –
  • 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 lips, face, throat or tongue;
• increased potassium levels in blood – this is more likely in patients with kidney disease or diabetes; the doctor may check this with a blood test;
• increased number of eosinophils in 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 muscle weakness (especially in the lower part of the body) after lumbar puncture or spinal/epidural anaesthesia;
• loss of bladder or bowel control (a condition in which the patient cannot control when they need to go to the toilet);
• hardening or lump at the injection site.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw.
Tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Enoxaparin sodium Ledraxen

Do not store above 25°C.
Do not freeze.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if any changes in the appearance of the solution are noticed.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack 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 volume of 0.2 mL contains 2000 IU anti-Xa activity (equivalent to 20 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

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 volume of 0.4 mL contains 4000 IU anti-Xa activity (equivalent to 40 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

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 volume of 0.6 mL contains 6000 IU anti-Xa activity (equivalent to 60 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

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 volume of 0.8 mL contains 8000 IU anti-Xa activity (equivalent to 80 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

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 volume of 1.0 mL contains 10,000 IU anti-Xa activity (equivalent to 100 mg) of enoxaparin sodium.
• The other ingredient is water for injections.

What Enoxaparin sodium Ledraxen looks like and contents of the pack
2000 IU (20 mg)/0.2 mL solution for injection:
Colourless or slightly yellow, clear liquid.
0.2 mL solution in a pre-filled syringe made of neutral glass of Class I with a fixed needle closed with a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Packs containing 1, 2, 6, 10, 20 or 50 pre-filled syringes.

4000 IU (40 mg)/0.4 mL solution for injection:
Colourless or slightly yellow, clear liquid.
0.4 mL solution in a pre-filled syringe made of neutral glass of Class I with a fixed needle closed with a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Packs containing 1, 2, 6, 10, 20, 30 or 50 pre-filled syringes.

6000 IU (60 mg)/0.6 mL solution for injection:
Colourless or slightly yellow, clear liquid.
0.6 mL solution in a pre-filled syringe made of neutral glass of Class I with a fixed needle closed with a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Packs containing 1, 2, 6, 10, 12, 20, 24, 30 or 50 pre-filled syringes.

8000 IU (80 mg)/0.8 mL solution for injection:
Colourless or slightly yellow, clear liquid.
0.8 mL solution in a pre-filled syringe made of neutral glass of Class I with a fixed needle closed with a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Packs containing 1, 2, 6, 10, 12, 20, 24, 30 or 50 pre-filled syringes.

10,000 IU (100 mg)/1 mL solution for injection:
Colourless or slightly yellow, clear liquid.
1 mL solution in a pre-filled syringe made of neutral glass of Class I with a fixed needle closed with a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Packs containing 1, 2, 6, 10, 12, 20, 24 or 30 pre-filled syringes.

Pre-filled syringes with a volume of 0.2 mL and 0.4 mL do not have graduations.
Pre-filled syringes with a volume of 0.6 mL, 0.8 mL and 1 mL are graduated.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Venipharm
4 Bureaux de la Colline
92210 Saint-Cloud
France
+33 1 47 11 0447
[email protected]

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

This medicinal product has been authorised in the EEA Member States under the following names:
Austria: Enoxaparin Ledraxen
Cyprus: Ledraxen
Czech Republic: Enoxaparin sodium Ledraxen
Finland: Enoxaparin Ledraxen
Croatia: Enoksaparinnatrij Ledraxen
United Kingdom (Northern Ireland): Enoxaparin Ledraxen
Lithuania: Enoxaparin sodium Ledraxen
Latvia: Enoxaparin sodium Ledraxen
Norway: Enoxaparin Ledraxen
Poland: Enoxaparin sodium Ledraxen
Portugal: Enoxaparina sódica Ledraxen
Slovakia: Ledraxen
Slovenia: Enoksaparin Ledraxen
Germany: Enoxaparin Ledraxen
France: Enoxaparine Arrow
Sweden: Enoxaparin Ledraxen
Spain: Enoxaparina Ledraxen

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