CEREZYME POWDER FOR SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

IMIGLUCERASE

Prieinama:

SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC

ATC kodas:

A16AB02

INN (Tarptautinis Pavadinimas):

IMIGLUCERASE

Dozė:

200UNIT

Vaisto forma:

POWDER FOR SOLUTION

Sudėtis:

IMIGLUCERASE 200UNIT

Vartojimo būdas:

INTRAVENOUS

Vienetai pakuotėje:

5.3ML

Recepto tipas:

Prescription

Gydymo sritis:

ENZYMES

Produkto santrauka:

Active ingredient group (AIG) number: 0131511001; AHFS:

Autorizacija statusas:

MARKETED

Leidimo data:

1997-05-01

Prekės savybės

_ _
_Cerezyme® (imiglucerase for injection) Product Monograph _
_Page 1 of 33_
PRODUCT MONOGRAPH
PR
CEREZYME®
IMIGLUCERASE FOR INJECTION
(RECOMBINANT HUMAN SS-GLUCOCEREBROSIDASE ANALOGUE)
LYOPHILIZED POWDER
200 UNITS/VIAL AND 400 UNITS/VIAL
ENZYME REPLACEMENT THERAPY
Genzyme Canada, a division of Sanofi-Aventis Canada Inc.
800-2700 Matheson Blvd. East, West Tower
Mississauga, ON
L4W 4V9
www.genzyme.ca
Date of Approval:
April 15, 2014
Submission Control No: 135476
_ _
_Cerezyme® (imiglucerase for injection) Product Monograph _
_Page 2 of 33 _
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
..........