STREPTASE POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

STREPTOKINASE

Available from:

CSL BEHRING CANADA INC

ATC code:

B01AD01

INN (International Name):

STREPTOKINASE

Dosage:

250000UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

STREPTOKINASE 250000UNIT

Administration route:

INTRAVENOUS

Units in package:

10X6.5ML

Prescription type:

Schedule D

Therapeutic area:

THROMBOLYTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0107605001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2012-02-22

Summary of Product characteristics

CSL BEHRING CANADA, INC. STREPTASE
®
(STREPTOKINASE INJECTION) PRODUCT MONOGRAPH
PRODUCT MONOGRAPH
STREPTASE
®
(
STREPTOKINASE INJECTION)
250,000 IU; 750,000 IU; 1,500,000 IU
FIBRINOLYTIC AGENT
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
KIP 6L5
Date of Approval:
Date of Revision: February 23, 2007
Submission Control No: 112482
CSL BEHRING CANADA, INC. STREPTASE
®
(STREPTOKINASE INJECTION) PRODUCT MONOGRAPH
PRODUCT MONOGRAPH
NAME OF DRUG
STREPTASE
®
(Streptokinase Injection)
250,000 IU; 750,000 IU; 1,500,000 IU
THERAPEUTIC CLASSIFICATION
Fibrinolytic Agent
ACTION AND CLINICAL PHARMACOLOGY
STREPTASE
®
(streptokinase injection) acts with plasminogen (or plasmin) to
produce an
"activator complex" that converts residual plasminogen into the
proteolytic enzyme, plasmin.
Plasmin is capable of hydrolyzing fibrin into polypeptides; it also
hydrolyzes fibrinogen and
other plasma proteins. Since plasminogen is present in the
thrombus/embolus, activation by
STREPTASE
®
occurs within the thrombus/embolus as well as on its surface.
The activity of streptokinase is expressed in International Units (IU)
and is a measure of its
ability to cause lysis of a fibrin clot via the plasmin system
_in vitro_
. The effect on coagulation
after intravenous administration may persist for 12 to 24 hours after
discontinuation due to a
decrease in plasma levels of fibrinogen and an increase in the amount
of circulating fibrin(ogen)
degradation products (FDP). Studies with radioactive streptokinase
indicate two disappearance
rates: a "fast" half-life of approximately 18 minutes due to the
action of antibodies, and a "slow"
half-life, operative in the absence of antibodies, of approximately 83
minutes. Effective blood
level and disappearance rate are dependent upon availability of
substrates and, thus, are only
relative indices of the pharmacologic effects of the drug. The
efficacy of STREPTASE
®
in the
lysis of venous thrombi and massive pulmonary emboli has been
established in clinical studies
by angiographic