Enoxaparine-BP

Enoxaparinum natricum

Enoxaparin-BP 2000 IU (20 mg)/0.2 ml; 4000 IU (40 mg)/0.4 ml; 8000 IU (80 mg)/0.8 ml; 10000 IU (100 mg)/1 ml — each pre-filled syringe contains enoxaparin sodium at the stated anti-Xa activity, in water for injections. Enoxaparin sodium is a biological medicine obtained by alkaline depolymerisation of the benzyl ester of heparin from porcine intestinal mucosa.

Indication: Prophylaxis of venous thromboembolic disease in patients at moderate and high risk undergoing surgery, or with acute medical conditions and reduced mobility; treatment of deep vein thrombosis and pulmonary embolism (excluding PE likely to require thrombolytic therapy or surgery); prevention of clot formation in the extracorporeal circuit during haemodialysis; acute coronary syndrome (unstable angina and myocardial infarction with/without ST-segment elevation) in combination with standard therapy.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Enoxaparin sodium is contraindicated in patients with: − Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including low molecular weight heparins (LMWH), or to any of the excipients listed in section 6.1; − History of immune-mediated heparin-induced thrombocytopenia (HIT) within the past 100 days or in the presence of circulating antibodies (see also section 4.4); − Active, clinically significant bleeding and conditions with a high risk of haemorrhage, including recent haemorrhagic stroke, gastrointestinal ulcer, presence of malignant neoplasm at high risk of bleeding, recent brain, spinal or ophthalmic surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities; − Spinal or epidural anaesthesia or loco-regional anaesthesia, when enoxaparin sodium has been used at a curative dose within the previous 24 hours (see section 4.4).

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use General Enoxaparin sodium cannot be used interchangeably (unit for unit) with other LMWHs. These medicinal products differ in their manufacturing process, molecular weight, specific anti-Xa and anti-IIa activity, units, doses, and clinical efficacy and safety. This results in differences in pharmacokinetics and associated biological activities (e.g. antithrombin activity and platelet interactions). Special care and compliance with the instructions for use specific to each medicinal product are therefore required. History of HIT (>100 days) Use of enoxaparin sodium is contraindicated in patients with a history of immune-mediated HIT within the past 100 days or in the presence of circulating antibodies (see section 4.3). Circulating antibodies may persist for several years. Enoxaparin sodium should be […]