TARO-BORTEZOMIB POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Disponible depuis:

TARO PHARMACEUTICALS INC

Code ATC:

L01XG01

DCI (Dénomination commune internationale):

BORTEZOMIB

Dosage:

1MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 1MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0150433003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-11-01

Résumé des caractéristiques du produit

Taro-Bortezomib (Bortezomib for Injection)
Page 1 of 86
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-BORTEZOMIB
Bortezomib for Injection
Sterile Lyophilized Powder for Injection,
1 mg, 2.5 mg and 3.5 mg / vial bortezomib, as the mannitol boronic
ester,
Intravenous or subcutaneous
Antineoplastic Agent
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario
Canada, L6T 1C1
Date of Initial Authorization:
May 14, 2020
Date of Revision:
September 21, 2022
Submission Control Number: 263204
Taro-Bortezomib (Bortezomib for Injection)
Page 2 of 86
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
02/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
TABLE OF CONTENTS
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
...........................................................................5
4 DOSAGE AND ADMINISTRATION
...............................................................................................5
4.1 Dosing Considerations
..........................................................................