MYOZYME POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ALGLUCOSIDASE ALFA

Διαθέσιμο από:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

Φαρμακολογική κατηγορία (ATC):

A16AB07

INN (Διεθνής Όνομα):

ALGLUCOSIDASE ALFA

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

ALGLUCOSIDASE ALFA 50MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

10.3ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ENZYMES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2006-08-14

Αρχείο Π.Χ.Π.

_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
.............