Land: Canada
Språk: engelsk
Kilde: Health Canada
ALTEPLASE; WATER
HOFFMANN-LA ROCHE LIMITED
B01AD02
ALTEPLASE
100MG; 100ML
LIQUID
ALTEPLASE 100MG; WATER 100ML
INTRAVENOUS
100 ML
Prescription
THROMBOLYTIC AGENTS
Active ingredient group (AIG) number: 0224091002; AHFS:
MARKETED
1996-12-31
_PR_ _ACTIVASE_ _®_ _ rt-PA (alteplase for injection) _ _Page 1 of 45_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ACTIVASE® RT-PA alteplase for injection LYOPHILIZED POWDER FOR INJECTION - 50 MG AND 100 MG Fibrinolytic Agent ACUTE MYOCARDIAL INFARCTION INDICATION ONLY Hoffmann-La Roche Limited 7070 Mississauga Road Mississauga, Ontario L5N 5M8 Date of Initial Authorization: DEC 31, 1996 Date of Revision: OCT 7, 2021 www.rochecanada.com Submission Control Number: 251948 ACTIVASE® is a registered trade mark of Genentech, Inc., used under license © Copyright 1996 - 2021 Hoffmann-La Roche Limited _ _ _PR_ _ACTIVASE_ _®_ _ rt-PA (alteplase for injection) _ _Page 2 of 45_ RECENT MAJOR LABEL CHANGES 3 Dosage and Administration, 3.3 Reconstitution April 19, 2021 3 Dosage and Administration, 3.4 Administration April 19, 2021 SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 2 SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. ... 2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION................................................................................. 5 4.1 Dosing Consi Les hele dokumentet