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Outline
What is the generic name?
DALTEPARIN SODIUM
What is the Trade Name for DALTEPARIN SODIUM?
Fragmin
What are the Indications for DALTEPARIN SODIUM?
- 1 INDICATIONS AND USAGE FRAGMIN is a low molecular weight heparin (LMWH) indicated for Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 ) Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ( 1.2 ) Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months ( 1.3 ) Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients 1 month of age and older ( 1.4 ) Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE ( 1.5 ) 1.1 Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [see Clinical Studies (14.1) ] . 1.2 Prophylaxis of Deep Vein Thrombosis FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): In patients undergoing hip replacement surgery [see Clinical Studies (14.2) ] ; In patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.3) ] ; In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness [see Clinical Studies (14.4) ] . 1.3 Extended Treatment of Symptomatic Venous Thromboembolism (VTE) in Adult Patients with Cancer FRAGMIN is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months [see Clinical Studies (14.5) ] . 1.4 Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients 1 month of age and older. 1.5 Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE.
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References: https://open.fda.gov/
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