BORTEZOMIB POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Dostupné s:

APOTEX INC

ATC kód:

L01XG01

INN (Mezinárodní Name):

BORTEZOMIB

Dávkování:

3.5MG

Léková forma:

POWDER FOR SOLUTION

Složení:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 3.5MG

Podání:

INTRAVENOUS

Jednotky v balení:

10ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2016-06-29

Charakteristika produktu

_BORTEZOMIB (Bortezomib) _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BORTEZOMIB
Bortezomib for Injection
Lyophilized powder, 3.5 mg/vial bortezomib (as the mannitol boronic
ester),
Intravenous or subcutaneous injection
Antineoplastic Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
June 29, 2016
Date of Revision:
September 8, 2023
Submission Control Number: 273587
_BORTEZOMIB (Bortezomib) _
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_Page 2 of 92 _
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RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
09/2023
1 INDICATIONS
09/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
09/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
09/2023
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
...................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1
Dosing Considerations
.......................................................................