Heparin Sodium Injection

INDICATIONS AND USAGE Heparin Sodium Injection is indicated for: • Prophylaxis and treatment of venous thrombosis and pulmonary embolism; • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; • Atrial fibrillation with embolization; • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); • Prevention of clotting in arterial and cardiac surgery; • Prophylaxis and treatment of peripheral arterial embolism. • Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures.

ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hemorrhage [see WARNINGS AND PRECAUTIONS (5.2)] • Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia and Thrombosis [see WARNINGS AND PRECAUTIONS (5.3)] • Risk of Serious Adverse Reactions in Infants Due to Benzyl Alcohol Preservative [see WARNINGS AND PRECAUTIONS (5.4)] • Thrombocytopenia [see WARNINGS AND PRECAUTIONS (5.5)] • Heparin Resistance [see WARNINGS AND PRECAUTIONS (5.7)] • Hypersensitivity [see WARNINGS AND PRECAUTIONS (5.8)] 6.1 Postmarketing Experience The following adverse reactions have been identified during post approval use of heparin sodium injection.

WARNINGS AND PRECAUTIONS 5.1 Fatal Medication Errors Do not use heparin sodium injection as a “catheter lock flush” product. Heparin sodium injection is supplied in vials containing various strengths of heparin, including vials that contain a highly concentrated solution of 10,000 units in 1 mL. Fatal hemorrhages have occurred in pediatric patients due to medication errors in which 1 mL heparin sodium injection vials were confused with 1 mL “catheter lock flush” vials. Carefully examine all heparin sodium injection vials to confirm the correct vial choice prior to administration of the drug. 5.2 Hemorrhage Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks. CONTRAINDICATIONS The use of heparin sodium injection is contraindicated in patients with the following conditions: • History of heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis [see WARNINGS AND PRECAUTIONS (5.3)]; • Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see ADVERSE REACTIONS (6.1)] • In whom suitable blood coagulat...