TNKASE POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

TENECTEPLASE

Verfügbar ab:

HOFFMANN-LA ROCHE LIMITED

ATC-Code:

B01AD11

INN (Internationale Bezeichnung):

TENECTEPLASE

Dosierung:

50MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

TENECTEPLASE 50MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

10 ML

Verschreibungstyp:

Prescription

Therapiebereich:

THROMBOLYTIC AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0145681001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2001-10-17

Fachinformation

_TNKase (tenecteplase for injection) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TNKASE
®
tenecteplase for injection
Powder for Solution - 50 mg/Vial
Sterile, Lyophilized
Intravenous Bolus Injection
Fibrinolytic Agent
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
Date of Initial Authorization:
October 18, 2001
Date of Revision:
March 21, 2023
Submission Control Number: 268350
TNKase
®
is a registered trade-mark of Hoffmann-La Roche Limited
Activase
®
rt-PA is a registered trade-mark of Genentech, Inc., used under
license
©
Copyright 2001 –2023 Hoffmann-La Roche Limited
_TNKase (tenecteplase for injection) _
_Page 2 of 32_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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...................................................................................4
4.1
Dosing Considerations
.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.3
Reconstitution
.....................................................................................................5
4.4
Administration
....................