ACTIVASE RT-PA LIQUID

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ALTEPLASE; WATER

Διαθέσιμο από:

HOFFMANN-LA ROCHE LIMITED

Φαρμακολογική κατηγορία (ATC):

B01AD02

INN (Διεθνής Όνομα):

ALTEPLASE

Δοσολογία:

50MG; 50ML

Φαρμακοτεχνική μορφή:

LIQUID

Σύνθεση:

ALTEPLASE 50MG; WATER 50ML

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

100 ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

THROMBOLYTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0224091001; AHFS:

Καθεστώς αδειοδότησης:

MARKETED

Ημερομηνία της άδειας:

1998-04-12

Αρχείο Π.Χ.Π.

_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