MYOZYME POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ALGLUCOSIDASE ALFA

Disponibil de la:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

Codul ATC:

A16AB07

INN (nume internaţional):

ALGLUCOSIDASE ALFA

Dozare:

50MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

ALGLUCOSIDASE ALFA 50MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

10.3ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ENZYMES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2006-08-14

Caracteristicilor produsului

_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
.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
Pediatrics
..........................................................................................................................
4
Geriatrics
..........................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND ADMINISTRATION
.............