Enoxaparin Ledraxen® 10.000 IE (100 mg)/1 ml – Solution for Injection

Overview
Enoxaparin Ledraxen® is a high-strength, sterile anticoagulant solution manufactured by Venipharm. It contains Enoxaparin Sodium, a Low Molecular Weight Heparin (LMWH) that effectively inhibits clotting factors to prevent and treat thromboembolic disorders. This presentation (10.000 IE/1 ml) is designed for therapeutic dosing requiring higher anticoagulant activity. It is suitable for both subcutaneous and intravenous administration and is supplied in a box of 10 ready-to-use pre-filled syringes, each featuring an integrated safety system for optimal healthcare professional protection.

Key Features and Benefits

• High Therapeutic Strength: Each pre-filled syringe delivers exactly 10.000 IE Anti-Xa (100 mg) of Enoxaparin Sodium in a 1 ml solution, making it ideal for therapeutic treatment protocols requiring higher doses.
• Dual Route of Administration: Formulated for flexible use, indicated for both subcutaneous injection (therapeutic anticoagulation) and intravenous use (for specific procedures including bolus administration).
• Extracorporeal Application: Specifically indicated for use in extracorporeal circuits, particularly the dialysis circuit, to maintain circuit patency during hemodialysis sessions by preventing clot formation.
• Ready-to-Use Precision: The pre-filled format eliminates manual drawing errors, ensures dosing accuracy, and saves valuable clinical time.
• Advanced Safety System: Each syringe is equipped with a passive safety mechanism that activates immediately after injection, shielding the needle to significantly reduce the risk of accidental needle-stick injuries.
• Premium Pharmaceutical Quality: Manufactured by Venipharm, a trusted pharmaceutical company committed to excellence in critical care products.

Indications and Usage
Enoxaparin Ledraxen® (10.000 IE) is primarily indicated for:

• Treatment of Established Thromboembolism: For the therapeutic management of deep vein thrombosis (DVT) and pulmonary embolism (PE).
• Extracorporeal Circulation: Prevention of clot formation in the dialysis circuit during hemodialysis procedures.
• Acute Coronary Syndromes: As part of comprehensive management protocols for unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI), often in combination with antiplatelet therapy.
• Perioperative Thromboprophylaxis: In high-risk surgical patients requiring higher anticoagulant coverage.

Important Safety Information
This is a high-potency prescription medication intended for hospital or specialized clinical use only. It must be administered under the direct supervision of a qualified healthcare professional experienced in anticoagulant therapy.

• Monitoring: Regular monitoring of platelet counts and signs of bleeding is essential.
• Contraindications: Do not use in patients with active major bleeding, history of heparin-induced thrombocytopenia (HIT), recent cerebrovascular hemorrhage, or hypersensitivity to Enoxaparin or heparin derivatives.
• Spinal/Epidural Anesthesia: Caution is required due to risk of spinal hematoma when used concomitantly with neuraxial anesthesia.
• Storage: Store below 25°C. Protect from freezing. Keep out of reach of children.

Product Specifications

• Active Ingredient: Enoxaparin Sodium
• Strength: 10.000 IE Anti-Xa (equivalent to 100 mg)
• Volume: 1.0 ml
• Route of Administration: Subcutaneous or Intravenous (Extracorporeal)
• Format: 10 Pre-filled syringes with Integrated Safety System
• Manufacturer: Venipharm

Disclaimer: This description is for informational purposes only and does not constitute medical advice. Always consult the official product leaflet and a qualified healthcare professional for complete prescribing information, contraindications, and proper administration guidelines.