CABAZITAXEL FOR INJECTION SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

CABAZITAXEL

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

L01CD04

INN (International Name):

CABAZITAXEL

Dosering:

45MG

Lægemiddelform:

SOLUTION

Sammensætning:

CABAZITAXEL 45MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0152936002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2019-12-17

Produktets egenskaber

_Cabazitaxel for Injection _
_Page 1 of 53_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CABAZITAXEL FOR INJECTION
Concentrated Solution 10 mg/mL, Intravenous
(45 mg/4.5 mL & 60 mg/6 mL)
Manufacturer’s Standard
ANTINEOPLASTIC AGENT
L01CD04
Sandoz Canada Inc.
110, de Lauzon Street
Boucherville, QC J4B 1E6
Canada
Date of Initial Authorization
December 17, 2019
Date of Revision:
November 28, 2023
Submission Control Number: 278315
_ _
_Cabazitaxel for Injection _
_Page 2 of 53_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
02
/
2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
11/2023
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.......................................................................
5
1
INDICATIONS
...............................................................................................................
5
1.1
Pediatrics (<18 years of age)
..........................................................................
5
1.2
Geriatrics (≥ 65 years
age)..............................................................................
5
2
CONTRAINDICATIONS
..................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................. 6
4
DOSAGE AND ADMINISTRATION
..................................................................................
6
4.1
Dosing Considerations
...................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
................................................ 7
4.3
Reconstitution
...............................................