HEPALEAN 1000 USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HEPARIN SODIUM

Available from:

SCHERING-PLOUGH CANADA INC

ATC code:

B01AB01

INN (International Name):

HEPARIN

Dosage:

1000UNIT

Pharmaceutical form:

SOLUTION

Composition:

HEPARIN SODIUM 1000UNIT

Administration route:

INTRAVENOUS

Units in package:

1/10/30 ML

Prescription type:

Ethical

Therapeutic area:

HEPARINS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2011-11-30

Summary of Product characteristics

Control # 130406
Date of Approval: August 10, 2009
PACKAGE INSERT
HEPALEAN®
Heparin Sodium Injection U.S.P.
Anticoagulant
Porcine intestinal mucosa origin.
Schering-Plough Canada Inc., Kirkland, Québec H9H 4M7
DESCRIPTION
HEPALEAN® (heparin sodium injection) is a sterile, pyrogen-free
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 U.S.P. and is
labelled in terms of U.S.P. 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.
HEPALEAN®, being of intestinal mucosal origin, offers two advantages
over that derived from lung
tissue, namely, the potency of U.S.P. units per unit weight is higher
and the amount of protamine sulfate
required for neutralization of the heparin is much less.
ACTIONS
Heparin sodium 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.
Control # 130406
Date of Approval: August 10, 2009
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
surgery.
When using HEPALEAN®(