FABRAZYME POWDER FOR SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

AGALSIDASE BETA

Доступна з:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

Код атс:

A16AB04

ІПН (Міжнародна Ім'я):

AGALSIDASE BETA

Дозування:

5MG

Фармацевтична форма:

POWDER FOR SOLUTION

Склад:

AGALSIDASE BETA 5MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

1.1ML

Тип рецепту:

Prescription

Терапевтична области:

ENZYMES

Огляд продуктів:

Active ingredient group (AIG) number: 0149901001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2004-01-23

Характеристики продукта

_ _
_ _
_Product Monograph of FABRAZYME (Agalsidase Beta)_
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
FABRAZYME

Agalsidase Beta
(Recombinant human α-galactosidase A)
Lyophilized Powder
5 mg and 35 mg, Intravenous
Enzyme Replacement Therapy
ATC code: A16AB04
Sanofi Genzyme, a division of sanofi-aventis Canada Inc.
1755 Steeles Avenue West,
Toronto ON,
M2R 3T4
www.sanofi.ca
Date of Initial Authorization:
Jan 23, 2004
Date of Revision:
Apr 14, 2023
Submission Control Number: 269800
_ _
_ _
_Product Monograph of FABRAZYME (Agalsidase Beta)_
_Page 2 of 35_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics (≥ 8 years of age)
.....................................................................................
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
Reconstitution
.........................................................................................................
5
4.4
Administration
..