MYLOTARG POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

GEMTUZUMAB OZOGAMICIN

Verfügbar ab:

PFIZER CANADA ULC

ATC-Code:

L01FX02

INN (Internationale Bezeichnung):

GEMTUZUMAB OZOGAMICIN

Dosierung:

4.5MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

GEMTUZUMAB OZOGAMICIN 4.5MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0161991001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2019-11-28

Fachinformation

_MYLOTARG® (gemtuzumab ozogamicin for injection) – Product
Monograph _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYLOTARG
®
gemtuzumab ozogamicin for injection
lyophilized powder for solution for intravenous infusion only
4.5 mg single-use vial
Antineoplastic Agent
ATC Code : L01XC05 GEMTUZUMAB OZOGAMICIN
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
NOV 28, 2019
Date of Revision:
February 02, 2023
Submission Control Number: 262317
®
Wyeth LLC
Pfizer Canada ULC, Licensee
_ _
_MYLOTARG® (gemtuzumab ozogamicin for injection) – Product
Monograph _
_Page 2 of 44_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS,
01/2023
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...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose