FRAGMIN (dalteparin sodium) Contraindications

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FRAGMIN should not be used in patients who have the following:

  • Hypersensitivity to FRAGMIN or any of its constituents, including benzyl alcohol (when using the 25,000 IU multi-dose vial) (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women), or to other low molecular weight heparins (LMWHs) and/or heparin or pork products.
  • History of confirmed or suspected immunologically-mediated heparin-induced thrombocytopenia (delayed-onset severe thrombocytopenia), and/or in patients in whom an in vitro platelet-aggregation test in the presence of FRAGMIN is positive
  • Septic endocarditis (endocarditis lenta, acute or subacute endocarditis)
  • Uncontrollable active bleeding
  • Major blood clotting disorders
  • Acute gastroduodenal ulcer
  • Cerebral hemorrhage
  • Severe uncontrolled hypertension
  • Diabetic or hemorrhagic retinopathy
  • Other conditions or diseases involving an increased risk of hemorrhage
  • Injuries to and operations on the central nervous system, eyes, and ears
  • Spinal/epidural anesthesia is contraindicated where concomitant treatment with repeated high doses of FRAGMIN (100-120 IU/kg given twice daily or 200 IU/kg once daily, such as those needed to treat acute deep-vein thrombosis and unstable coronary artery disease) are required, due to an increased risk of bleeding