NAT-AZACITIDINE POWDER FOR SUSPENSION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

AZACITIDINE

Beszerezhető a:

NATCO PHARMA (CANADA) INC

ATC-kód:

L01BC07

INN (nemzetközi neve):

AZACITIDINE

Adagolás:

100MG

Gyógyszerészeti forma:

POWDER FOR SUSPENSION

Összetétel:

AZACITIDINE 100MG

Az alkalmazás módja:

SUBCUTANEOUS

db csomag:

100MG

Recept típusa:

Prescription

Terápiás terület:

ANTINEOPLASTIC AGENTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0152665001; AHFS:

Engedélyezési státusz:

CANCELLED PRE MARKET

Engedély dátuma:

2023-05-11

Termékjellemzők

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-AZACITIDINE
Azacitidine for Injection
Powder, 100 mg azacitidine per vial, for subcutaneous use
Antineoplastic Agent
Pyrimidine Analogue
Natco Pharma (Canada) Inc.
2000 Argentia Road
Plaza 1, Suite 200
Mississauga, ON
L5N 1P7
Date of Initial Authorization:
August 16, 2018
Date of Revision:
January 16, 2023
Submission Control Number: 267064
_NAT-AZACITIDINE, Azacitidine for injection _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
01/2023
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2023
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.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstit