FRAGMIN (dalteparin sodium) Indications And Clinical Use

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Canada
 

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FRAGMIN (Dalteparin Sodium Injection) is indicated for:

  • Thromboprophylaxis in conjunction with surgery
  • Treatment of acute deep venous thrombosis
  • Unstable coronary artery disease (UCAD), i.e., unstable angina and non-Q-wave myocardial infarction
  • Prevention of clotting in the extracorporeal system during hemodialysis and hemofiltration in connection with acute renal failure or chronic renal insufficiency
  • Extended treatment of symptomatic venous thromboembolism (VTE) to prevent recurrence of venous thromboembolism in patients with cancer
  • Reduction of deep vein thrombosis (DVT) in hospitalized patients with severely restricted mobility during acute illness. Decreased mortality due to thromboembolic events and complications has not been demonstrated

Pediatrics (2 weeks – 18 years): Health Canada has not authorized an indication for pediatric use. There is limited safety and efficacy information on the use of dalteparin in pediatric patients (see WARNINGS AND PRECAUTIONS, Special populations, Pediatrics; Monitoring and Laboratory Tests and DOSAGE AND ADMINISTRATION, Dosage, Use in Pediatrics). 
 
Geriatrics: Elderly patients may be at an increased risk for bleeding complications within the therapeutic dosage ranges. Careful clinical monitoring is advised (see WARNINGS AND PRECAUTIONS, Special populations and Monitoring and Laboratory Tests).