NEXVIAZYME POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

AVALGLUCOSIDASE ALFA

Verfügbar ab:

SANOFI-AVENTIS CANADA INC

ATC-Code:

A16AB22

INN (Internationale Bezeichnung):

AVALGLUCOSIDASE ALFA

Dosierung:

100MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

AVALGLUCOSIDASE ALFA 100MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

ENZYMES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0163274001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2021-11-12

Fachinformation

_ _
_Product Monograph _
_NEXVIAZYME™ avalglucosidase alfa for injection _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NEXVIAZYME™
avalglucosidase alfa for injection
Lyophilized Powder
100 mg/vial, intravenous infusion
Enzyme Replacement Therapy
sanofi-aventis Canada Inc.
1755 Steeles Avenue West
Toronto ON
M2R 3T4
Distributed by:
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
1755 Steeles Avenue West,
Toronto ON
M2R 3T4
Date of Initial Approval:
November 12, 2021
Date of Revision:
May 11, 2023
Submission Control No: 270061
_ _
_Product Monograph _
_NEXVIAZYME™ avalglucosidase alfa for injection _
_Page 2 of 26_
RECENT MAJOR LABEL CHANGES
[Section number and heading], [Subsection number and heading]
[MM/YYYY]
[Section number and heading], [Subsection number and heading]
[MM/YYYY]
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES ......................................................................................................
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................................
4
4
DOSAGE AND ADMINISTRATION ..................