PMS-AZACITIDINE FOR INJECTION POWDER FOR SUSPENSION

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

AZACITIDINE

Доступна с:

PHARMASCIENCE INC

код АТС:

L01BC07

ИНН (Международная Имя):

AZACITIDINE

дозировка:

100MG

Фармацевтическая форма:

POWDER FOR SUSPENSION

состав:

AZACITIDINE 100MG

Администрация маршрут:

SUBCUTANEOUS

Штук в упаковке:

100

Тип рецепта:

Prescription

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2022-10-26

Характеристики продукта

_pms-AZACITIDINE FOR INJECTION (Azacitidine for injection) _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-AZACITIDINE FOR INJECTION
Azacitidine for injection
Powder, 100 mg azacitidine per vial, for subcutaneous use
Antineoplastic Agent
Pyrimidine Analogue
PHARMASCIENCE INC.
6111 Royalmount Ave. Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
October 14, 2022
Submission Control Number: 242010
_pms-AZACITIDINE FOR INJECTION (Azacitidine for injection) _
_Page 2 of 46_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...............................................Error! Bookmark not
defined.
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
........................................................... 5
4
DOSAGE AND ADMINISTRATION
...............................................................................
5
4.1
Dosing
Considerations................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................. 5
4.3
Reconstitution
...........................................................................