FRAGMIN 2 Contraindications

dalteparin sodium

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Fragmin (dalteparin sodium injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, any non-medicinal ingredient (including benzyl alcohol when using the 25,000 IU multi-dose vial (see 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women) to other low molecular weight heparins (LMWHs) and/or heparin or pork products, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

Fragmin (dalteparin sodium injection) is also contraindicated in patients who have the following:

  • 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
)

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2 Contraindications

Fragmin (dalteparin sodium injection) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, any non-medicinal ingredient (including benzyl alcohol when using the 25,000 IU multi-dose vial (see 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women) to other low molecular weight heparins (LMWHs) and/or heparin or pork products, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

Fragmin (dalteparin sodium injection) is also contraindicated in patients who have the following:

  • 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

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