HEPARIN SODIUM INJECTION, USP SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

HEPARIN SODIUM

Disponibil de la:

FRESENIUS KABI CANADA LTD

Codul ATC:

B01AB01

INN (nume internaţional):

HEPARIN

Dozare:

1000UNIT

Forma farmaceutică:

SOLUTION

Compoziție:

HEPARIN SODIUM 1000UNIT

Calea de administrare:

INTRAVENOUS

Unități în pachet:

1/10/30 ML

Tip de prescriptie medicala:

Ethical

Zonă Terapeutică:

HEPARINS

Rezumat produs:

Active ingredient group (AIG) number: 0104596004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2006-10-06

Caracteristicilor produsului

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