BLINCYTO POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

BLINATUMOMAB

Commercializzato da:

AMGEN CANADA INC

Codice ATC:

L01FX07

INN (Nome Internazionale):

BLINATUMOMAB

Dosaggio:

38.5MCG

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

BLINATUMOMAB 38.5MCG

Via di somministrazione:

INTRAVENOUS

Confezione:

265ML TO 275ML (STARTING VOL)

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0157670001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2015-12-22

Scheda tecnica

_ _
_BLINCYTO (blinatumomab) _
_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BLINCYTO
®
blinatumomab for injection
Lyophilized powder for solution for infusion, 38.5 mcg
Professed Standard
Anti-neoplastic Agent
ATC code: L01FX07
Submission Control Number: 269288
© 2015-2023 Amgen Canada Inc., All Rights Reserved.
Amgen Canada Inc.
6775 Financial Drive, Suite 300
Mississauga, Ontario
L5N 0A4
Date of Initial Authorization:
December 22, 2015
Date of Revision:
August 29, 2023
_ _
_BLINCYTO (blinatumomab) _
_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
1.1 Pediatrics
XX/2023
4.2 Recommended Dose and Dosage Adjustment
XX/2023
4.4 Administration
XX/2023
7.1.3 Pediatrics
XX/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
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
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.3
Reconstitution
......................................................................................................
11
4.4
Administration
.....................................