Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
HEPARIN SODIUM
FRESENIUS KABI CANADA LTD
B01AB01
HEPARIN
10000UNIT
SOLUTION
HEPARIN SODIUM 10000UNIT
INTRAVENOUS
25 VIALS
Ethical
HEPARINS
Active ingredient group (AIG) number: 0104596002; AHFS:
APPROVED
2018-10-31
Heparin Sodium Injection, USP - Prescribing Information Page 1 of 17 PRESCRIBING INFORMATION HEPARIN SODIUM INJECTION, USP 1000 USP Units / mL, 10 000 USP Units / mL vials 5000 USP Units / 0.5 mL Prefilled Syringe Sterile Solution For Intravenous or Subcutaneous Use FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 DATE OF INITIAL AUTHORIZATION: May 26, 2005 SUBMISSION CONTROL NUMBER: 242422 DATE OF REVISION: April 15, 2021 Heparin Sodium Injection, USP - Prescribing Information Page 2 of 17 HEPARIN SODIUM INJECTION, USP ANTICOAGULANT DESCRIPTION Heparin Sodium Injection, USP is a sterile, non-pyrogenic solution of a highly purified sodium salt of heparin, a high molecular weight polysaccharide derived from porcine intestinal mucosa. It is standardized _ in vitro_ according to the method of USP and is labeled in terms of USP units for use as an anticoagulant. It acts very rapidly and, even in large doses, is metabolized in the body and eliminated within 24 hours. It will not lyse existing thrombi or emboli. ACTIONS Heparin inhibits the clotting of blood and the formation of fibrin clots both _ in vitro_ and _in vivo_. In combination with a cofactor, it inactivates thrombin thus preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin sodium inhibits reactions which lead to clotting but does not alter the normal components of the blood. Although clotting time is prolonged by therapeutic doses, bleeding time is usually unaffected. Heparin sodium does not have fibrinolytic activity; therefore, it will not lyse existing clots. INDICATIONS Used in the treatment of thrombophlebitis, phlebothrombosis, and cerebral, coronary, and retinal vessel thrombosis to prevent extension of clots and thromboembolic phenomena. Also used prophylactically to prevent the occurrence of thromboembolism, and to prevent clotting during dialysis and surgical procedures, particularly vascular sur Přečtěte si celý dokument