TARO-BORTEZOMIB POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

זמין מ:

TARO PHARMACEUTICALS INC

קוד ATC:

L01XG01

INN (שם בינלאומי):

BORTEZOMIB

כמות:

3.5MG

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 3.5MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2020-05-14

מאפייני מוצר

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
..........................................................................