ZIRABEV SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BEVACIZUMAB

Commercializzato da:

PFIZER CANADA ULC

Codice ATC:

L01FG01

INN (Nome Internazionale):

BEVACIZUMAB

Dosaggio:

100MG

Forma farmaceutica:

SOLUTION

Composizione:

BEVACIZUMAB 100MG

Via di somministrazione:

INTRAVENOUS

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2019-06-14

Scheda tecnica

_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
...............