Heparin Sodium Injection, USP Prefilled Syringe with Attached Safety Needle

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5,000 USP Units per 0.5 mL (10,000 USP Units per mL)

Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for use as an anticoagulant. It is to be administered by intravenous or subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Each mL contains 10,000 USP units heparin sodium, in water for injection and hydrochloric acid or sodium hydroxide for PH adjustment. The PH range is 5.0 to 7.5.

Indications:
Heparin Sodium Injection, USP is indicated for:

  • Anticoagulant therapy in prophylaxis and treatment of venous thrombosis and its extension;
  • Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery who are at risk of developing thromboembolic disease
    Prophylaxis and treatment of pulmonary embolism;
    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;
    Heparin may also be employed as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.


Contraindications:
Heparin Sodium should NOT be used in patients with the following conditions:

  • Severe thrombocytopenia;
  • When suitable blood coagulation tests – e.g.,the whole blood clotting time, partial thromboplastin time, etc., cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin);
  • An uncontrollable active bleeding state except when this is due to disseminated intravascular coagulation.


How Supplied:

Heparin Sodium Injection, USP, is available in Prefilled Syringe Needle Units. Each prefilled syringe contains the following concentration of heparin sodium:

  • 5,000 USP Units per 0.5 mL (10,000 USP Units per mL)
  • NDC 0264-5705-10 REF PFS5705 (27 gauge x ½ inch needle), in packages of 10 prefilled syringes.
    Store at 68°-77°F (20°-25°C) [See USP Controlled Room Temperature].
  • Do not freeze.
  • Do not use if solution is discolored or contains precipitate.

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Heparin Sodium Injection, USP Instructions For Use