EPARs - Arixtra//Fondaparinux sodium

FICHA FARMACOLÓGICA de Fondaparinux sodium. Contiene la Monografía en distintos idiomas (de la Comunidad Económica Europea), así como la discusión científica que sustenta su aprobación terapéutica. Para acceder a la monografía en idioma español, hacer doble clik en la sigla (es) en la fila que se sitúa más abajo del centro de la página oficial. Cerasale. MAYO 09, 2009.-

ABRIR AQUÍ:
EPARs for authorised medicinal products for human use - Arixtra

Active Substance
Fondaparinux sodium
International Nonproprietary Name or Common Name
Fondaparinux sodium
Pharmaco-therapeutic Group
Other antithrombotic agents
ATC Code
B01AX05

Therapeutic Indication:
1.5 mg/0.3 ml and 2.5 mg/0.5 ml, solution for injection:
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.

Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).

Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.

2.5 mg/0.5 ml, solution for injection
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).

Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy.

5 mg/0.4 ml, 7.5 mg/0.6 ml and 10 mg/0.8 ml solution for injection:

Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Date of issue of Marketing Authorisation valid throughout the European Union
21 March 2002