ZIRABEV SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

BEVACIZUMAB

Verfügbar ab:

PFIZER CANADA ULC

ATC-Code:

L01FG01

INN (Internationale Bezeichnung):

BEVACIZUMAB

Dosierung:

100MG

Darreichungsform:

SOLUTION

Zusammensetzung:

BEVACIZUMAB 100MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0151381001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2019-06-14

Fachinformation

_ZIRABEV (bevacizumab for injection) _
_Page 1 of 98_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZIRABEV
®
Bevacizumab for injection
100 mg and 400 mg vials (25 mg/mL, solution for infusion)
Antineoplastic
ATC Code: L01FG01
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Approval:
June 14, 2019
Date of Revision:
October 19, 2023
SUBMISSION CONTROL NUMBER: 277377
®
Pfizer Inc.
Pfizer Canada ULC, Licensee
_ _
_ZIRABEV (bevacizumab for injection) _
_Page 2 of 98_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
09/2023
4 DOSAGE AND ADMINISTRATION; 4.4 Recommended
Dose and Dosage Adjustment
09/2023
8 ADVERSE REACTIONS; 8.5 Post-Market Adverse
Reactions
03/2023
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
.................................................................................................................
5
1.2
Geriatrics
.................................................................................................................
5
2
CONTRAINDICATIONS ............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................... 5
4
DOSAGE AND ADMINISTRATION .........................................................................
6
4.1
Dosing Considerations
.............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
...............