Maa: Kanada
Kieli: englanti
Lähde: Health Canada
STREPTOKINASE
CSL BEHRING CANADA INC
B01AD01
STREPTOKINASE
250000UNIT
POWDER FOR SOLUTION
STREPTOKINASE 250000UNIT
INTRAVENOUS
10X6.5ML
Schedule D
THROMBOLYTIC AGENTS
Active ingredient group (AIG) number: 0107605001; AHFS:
CANCELLED POST MARKET
2012-02-22
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 Lue koko asiakirja