BORTEZOMIB FOR INJECTION POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

L01XG01

DCI (Dénomination commune internationale):

BORTEZOMIB

Dosage:

3.5MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 3.5MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

I.V.:3.5ML/S.C:1.4ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0150433001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2014-12-18

Résumé des caractéristiques du produit

Bortezomib for Injection
Page 1 of 95
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BORTEZOMIB FOR INJECTION
Sterile Lyophilized Powder for Injection, 3.5 mg / vial bortezomib as
the mannitol boronic ester,
Intravenous or subcutaneous injection
Antineoplastic Agent
Teva Canada Limited
30 Novopharm Court,
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
December 18, 2014
Date of Revision:
December 14, 2022
Submission Control No. 265970
Bortezomib for Injection
Page 2 of 95
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
12/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................
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...................................................................
5
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing
Considerations.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 6
4.3
Reconstitution
....................................................................................................