MYLOTARG POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

GEMTUZUMAB OZOGAMICIN

Commercializzato da:

PFIZER CANADA ULC

Codice ATC:

L01FX02

INN (Nome Internazionale):

GEMTUZUMAB OZOGAMICIN

Dosaggio:

4.5MG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

GEMTUZUMAB OZOGAMICIN 4.5MG

Via di somministrazione:

INTRAVENOUS

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2019-11-28

Scheda tecnica

_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
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose