MYOZYME POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ALGLUCOSIDASE ALFA

Dostupné s:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC kód:

A16AB07

INN (Mezinárodní Name):

ALGLUCOSIDASE ALFA

Dávkování:

50MG

Léková forma:

POWDER FOR SOLUTION

Složení:

ALGLUCOSIDASE ALFA 50MG

Podání:

INTRAVENOUS

Jednotky v balení:

10.3ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ENZYMES

Přehled produktů:

Active ingredient group (AIG) number: 0151663001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2006-08-14

Charakteristika produktu

_Product Monograph Master Template _
_Template Date: September 2020 _
_MYOZYME (alglucosidase alfa) _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MYOZYME
®
alglucosidase alfa
(Recombinant human acid alpha-glucosidase)
Lyophilized Powder, 50 mg vial, intravenous infusion
ATC code: A16AB07
Enzyme Replacement Therapy
Produced by recombinant DNA technology in Chinese hamster ovary cell
line
Sanofi Genzyme, a division of sanofi-aventis
Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Authorization:
December 6, 2006
Date of Revision:
November 24, 2023
Submission Control No: 270219
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_ _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1.1 PREGNANT WOMEN
11/2022
7 WARNINGS AND PRECAUTIONS, 7.1.2 BREAST-FEEDING
11/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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RECENT MAJOR LABEL CHANGES
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TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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Pediatrics
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Geriatrics
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CONTRAINDICATIONS
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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DOSAGE AND ADMINISTRATION
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