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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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