BLINCYTO POWDER FOR SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

BLINATUMOMAB

Mevcut itibaren:

AMGEN CANADA INC

ATC kodu:

L01FX07

INN (International Adı):

BLINATUMOMAB

Doz:

38.5MCG

Farmasötik formu:

POWDER FOR SOLUTION

Kompozisyon:

BLINATUMOMAB 38.5MCG

Uygulama yolu:

INTRAVENOUS

Paketteki üniteler:

265ML TO 275ML (STARTING VOL)

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2015-12-22

Ürün özellikleri

_ _
_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
.....................................