HEPARIN SODIUM INJECTION, USP SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

HEPARIN SODIUM

제공처:

FRESENIUS KABI CANADA LTD

ATC 코드:

B01AB01

INN (국제 이름):

HEPARIN

복용량:

10000UNIT

약제 형태:

SOLUTION

구성:

HEPARIN SODIUM 10000UNIT

관리 경로:

INTRAVENOUS

패키지 단위:

1ML/5ML

처방전 유형:

Ethical

치료 영역:

HEPARINS

제품 요약:

Active ingredient group (AIG) number: 0104596002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2006-10-06

제품 특성 요약

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