Enoxaparin sodium ledraxen

Poland
Brand name Enoxaparin sodium ledraxen
Form solution for injection in ampoule-syringe
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 100457744
Enoxaparin sodium ledraxen solution for injection in ampoule-syringe

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 for rapid identification of new safety information. Users of the medicine can also help by reporting any adverse reactions that occur after administration. For information on how to report adverse reactions – 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 only. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

  1. What Enoxaparin sodium Ledraxen is and what it is used for
  2. What you need to know 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 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 dissolve existing clots so they are no longer harmful.
  2. It prevents the formation of new blood clots in the patient’s bloodstream.

Enoxaparin sodium Ledraxen may be used for:

  • Treating existing blood clots in the patient’s bloodstream.
  • Preventing the formation of blood clots in the patient in the following situations:
    • Before and after surgical procedures
    • During a short-term illness when the patient is unable to move around 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 reaches 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: 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 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:
    - peptic ulcers, recent brain or eye surgery, or recent hemorrhagic stroke.
  • the patient is being treated with Enoxaparin sodium Ledraxen for blood clots and a procedure is planned within the next 24 hours:
    - lumbar puncture
    - surgical procedure under spinal or epidural anaesthesia.

Do not use Enoxaparin sodium Ledraxen in the above-mentioned patients. If in doubt, discuss this with your doctor or pharmacist before starting treatment with Enoxaparin sodium Ledraxen.

Warnings and precautions
Do not interchange Enoxaparin sodium Ledraxen with other low-molecular-weight heparins. This is because they are not exactly the same and differ in activity and instructions for use.
Before starting treatment with Enoxaparin sodium Ledraxen, consult your doctor or pharmacist if:

  • the patient has ever had a reaction to heparin that caused a major drop in the number of blood cells responsible for blood clotting (platelets)
  • the patient has a prosthetic heart valve
  • the patient has endocarditis (an infection of the inner lining of the heart)
  • the patient has a history of peptic ulcers
  • the patient has recently had a stroke
  • the patient has hypertension
  • the patient has diabetes or has eye blood vessel disorders caused by diabetes (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 in 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 situations apply to the patient or if the patient has any doubts, discuss this with a doctor or pharmacist before starting treatment with Enoxaparin sodium Ledraxen.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

Tests and monitoring
Before starting this medicine and periodically during treatment, the patient may undergo blood tests to monitor the number of platelets (blood cells responsible for blood clotting) and blood potassium levels.

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

Enoxaparin sodium Ledraxen and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use, including:

  • 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 "Changing anticoagulant therapy")
  • 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 become pregnant, she should consult a doctor or pharmacist before using this medicine.
Women with a mechanical heart valve during pregnancy may have an 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 have not been established in children and adolescents.

Driving and using machines
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 are unsure,
you should 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 given by intramuscular injection. Dose of the medicine
  • Your doctor will decide how much Enoxaparin sodium Ledraxen you should receive. The dose depends on the reason for treatment.
  • 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 clots in the patient's blood 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.
  • For planned surgery, the first injection is usually given 2 hours or 12 hours before the procedure.
  • If your mobility is limited due to illness, you 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.

Non-ST-segment elevation myocardial infarction (NSTEMI):

  • The usual dose is 100 IU (1 mg) per kilogram of body weight every 12 hours.
  • Your doctor will usually also recommend that you take aspirin (acetylsalicylic acid).
  • Your doctor will decide how long you should continue receiving Enoxaparin sodium Ledraxen. ST-segment elevation myocardial infarction (STEMI) in patients under 75 years of age:
  • The initial dose of Enoxaparin sodium Ledraxen is 3000 IU (30 mg) given as an intravenous injection.
  • Enoxaparin sodium Ledraxen will also be administered 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 that you take aspirin (acetylsalicylic acid).
  • Your doctor will decide how long you should continue receiving Enoxaparin sodium Ledraxen. ST-segment elevation myocardial infarction (STEMI) 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. The medicine will then be given as an intravenous injection.
4) Prevention of blood clots 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 it. Do not attempt to inject yourself unless you have been properly trained. If you have any doubts about how to proceed, contact your doctor or nurse immediately. Correct subcutaneous injection technique (known as a "subcutaneous injection") may reduce pain and bruising at the injection site. Before self-injecting Enoxaparin sodium Ledraxen
  • Prepare all necessary items: syringe, alcohol swab or soap and water, and a container for medical waste.
  • Check the expiry date on the packaging. Do not use the medicine after the expiry date.
  • Check that the syringe is not damaged and that the liquid is clear. If not, use another syringe.
  • Confirm the dose to be injected.
  • Examine your abdomen to check whether the previous injection caused redness, skin discoloration, swelling, oozing, or if it is still painful. If so, contact your doctor or nurse.

Instructions for syringes without a safety device

  • Preparing the injection site: Before injecting, wash your hands and dry them. Use an alcohol swab to clean (without rubbing) the chosen injection site. For each injection, select a different area of the abdomen.
  • Remove the protective needle cap. A drop may appear at the needle tip. If so, remove the drop by tapping the syringe barrel (with the needle pointing downwards).
Schematic illustration of a syringe with a black arrow indicating rotational movement of the upper part and a small arrow suggesting the direction of displacement
  • 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 outer side. Hold the syringe so that the needle points downward (vertically at a 90° angle), into the thickness of a skin fold created by pinching the skin between your thumb and index finger. Hold the skin fold throughout the injection.
Hand holding a syringe with the needle pointing downward, inserting it into the upper arm, while the other hand stabilizes the patient's arm Two hands holding a syringe vertically, placing its tip against the upper part of the patient's body to administer medication
  • Immediately dispose of the syringe in an appropriate container.

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

  • Preparing the injection site: Before injecting, wash your hands and dry them. Use an alcohol swab to clean (without rubbing) the chosen injection site. For each injection, select a different area of the abdomen.
  • First, bend the safety guard sideways by approximately 90 degrees. Warning: Do not remove the needle cap before bending the safety guard.
Two hands holding a syringe, one hand pulling the plunger downward, indicated by a black arrow pointing downward
  • Remove the protective needle cap. A drop may appear at the needle tip. If so, remove the drop by tapping the pre-filled syringe barrel (with the needle pointing downwards).
Two hands holding a syringe filled with blue liquid, one hand unscrewing a blue cap in the direction indicated by a black arrow
  • 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 outer side. Hold the syringe so that the needle points downward (vertically at a 90° angle), into the thickness of a skin fold created by pinching the skin between your thumb and index finger. Hold the skin fold throughout the injection.
Hand holding a syringe at a 90-degree angle to the skin, directing the needle vertically downward toward the body part held by the second person
  • 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. Then press down on the safety guard. Continue pressing until the needle audibly clicks into the plastic part.
Hand holding an auto-injector pressing it against a flat surface, causing a characteristic click and release of sound Hands holding an auto-injector with a needle, tilting it at an angle toward a flat surface, indicated by a black curved arrow
  • Immediately dispose of the syringe in an appropriate container.

After the injection

  1. To avoid bruising, do not rub the injection site after the injection.
  2. Dispose of the used syringe in a medical waste container. Close the container lid and store it out of sight and 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 its waste must be disposed of in accordance with
    local regulations.
    Switching anticoagulant medicines
  • Switching from Enoxaparin sodium Ledraxen to oral anticoagulants 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 oral anticoagulants known as vitamin K antagonists (such as warfarin) to Enoxaparin sodium Ledraxen
    Stop taking 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 (DOACs)
    Stop taking Enoxaparin sodium Ledraxen. Start taking the direct oral anticoagulant 0 to 2 hours before the scheduled time of the next injection; then continue taking the medicine as usual.
  • Switching from direct oral anticoagulant therapy to Enoxaparin sodium Ledraxen
    Stop taking the direct oral anticoagulant. Enoxaparin sodium Ledraxen treatment may be started 12 hours after the last dose of the direct oral anticoagulant.

Using more than the 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 experience any symptoms. In case of accidental
injection or ingestion of Enoxaparin sodium Ledraxen by a child, seek emergency medical attention
immediately.
Missing a 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 any doses.
Stopping Enoxaparin sodium Ledraxen treatment
It is important to continue Enoxaparin sodium Ledraxen injections until your doctor tells you to stop.
If treatment is stopped prematurely, a blood clot may form, which could be very dangerous.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Serious side 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, inside of the 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 generalised 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 on its own;
  • the patient shows signs of excessive bleeding such as weakness, fatigue, paleness, dizziness with headache, or unexplained swelling. The doctor may decide to carry out further monitoring 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 skin 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 side 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;
  • feeling of tenderness and swelling in the stomach – this may indicate gastrointestinal bleeding;
  • large, irregularly shaped red skin lesions, 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 the 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 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 muscle weakness (especially in the lower part of the body) following 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 side effects

If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side 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, Poland.
Tel.: +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 authorisation holder.

Reporting side 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 observed.
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 syringe made of neutral glass of class I with a fixed needle closed by a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Pack sizes: 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 syringe made of neutral glass of class I with a fixed needle closed by a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Pack sizes: 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 syringe made of neutral glass of class I with a fixed needle closed by a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Pack sizes: 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 syringe made of neutral glass of class I with a fixed needle closed by a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Pack sizes: 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 syringe made of neutral glass of class I with a fixed needle closed by a protective cap, with a chlorobutyl rubber stopper and a polypropylene plunger, in a cardboard box.
Pack sizes: 1, 2, 6, 10, 12, 20, 24 or 30 pre-filled syringes.

For pre-filled syringes with a volume of 0.2 mL and 0.4 mL, there is no graduation mark on the syringe.
For pre-filled syringes with a volume of 0.6 mL, 0.8 mL and 1 mL, the syringes 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

Further information
Detailed information about 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