CEREZYME POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMIGLUCERASE

Available from:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC code:

A16AB02

INN (International Name):

IMIGLUCERASE

Dosage:

400UNIT

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

IMIGLUCERASE 400UNIT

Administration route:

INTRAVENOUS

Units in package:

10.6ML

Prescription type:

Prescription

Therapeutic area:

ENZYMES

Product summary:

Active ingredient group (AIG) number: 0131511002; AHFS:

Authorization status:

APPROVED

Authorization date:

2004-06-17

Summary of Product characteristics

_ _
_Cerezyme® (imiglucerase for injection) Product Monograph _
_Page 1 of 34_
PRODUCT MONOGRAPH
PR
CEREZYME®
IMIGLUCERASE FOR INJECTION
(RECOMBINANT HUMAN SS-GLUCOCEREBROSIDASE ANALOGUE)
LYOPHILIZED POWDER
400 UNITS/VIAL
ENZYME REPLACEMENT THERAPY
Sanofi Genzyme, a division of Sanofi-Aventis Canada Inc.
800-2700 Matheson Blvd. East, West Tower
Mississauga, ON
L4W 4V9
www.genzyme.ca
Date of Approval:
November 30, 2016
Submission Control No: 194013
_ _
_Cerezyme® (imiglucerase for injection) Product Monograph _
_Page 2 of 34 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND STABILITY
.........................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
..........................