Activase

Product manufactured by Genentech, Inc.

Application Nr Approved Date Route Status External Links
BLA103172 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Activase Is A Tissue Plasminogen Activator (Tpa) Indicated For The Treatment Of Acute Ischemic Stroke (Ais). ( 1.1 ) Acute Myocardial Infarction (Ami) To Reduce Mortality And Incidence Of Heart Failure. ( 1.2 ) Limitation Of Use In Ami: The Risk Of Stroke May Be Greater Than The Benefit In Patients At Low Risk Of Death From Cardiac Causes. ( 1.2 ) Acute Massive Pulmonary Embolism (Pe) For Lysis. ( 1.3 ) 1.1 Acute Ischemic Stroke Activase Is Indicated For The Treatment Of Acute Ischemic Stroke. Exclude Intracranial Hemorrhage As The Primary Cause Of Stroke Signs And Symptoms Prior To Initiation Of Treatment [See Contraindications (4.1) ] . Initiate Treatment As Soon As Possible But Within 3 Hours After Symptom Onset. 1.2 Acute Myocardial Infarction Activase Is Indicated For Use In Acute Myocardial Infarction (Ami) For The Reduction Of Mortality And Reduction Of The Incidence Of Heart Failure. Limitation Of Use: The Risk Of Stroke May Outweigh The Benefit Produced By Thrombolytic Therapy In Patients Whose Ami Puts Them At Low Risk For Death Or Heart Failure. 1.3 Pulmonary Embolism Activase Is Indicated For The Lysis Of Acute Massive Pulmonary Embolism, Defined As: Acute Pulmonary Emboli Obstructing Blood Flow To A Lobe Or Multiple Lung Segments. Acute Pulmonary Emboli Accompanied By Unstable Hemodynamics, E.g., Failure To Maintain Blood Pressure Without Supportive Measures.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Alteplase

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