VIMIZIM SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ELOSULFASE ALFA

Dostępny od:

BIOMARIN INTERNATIONAL LIMITED

Kod ATC:

A16AB12

INN (International Nazwa):

ELOSULFASE ALFA

Dawkowanie:

1MG

Forma farmaceutyczna:

SOLUTION

Skład:

ELOSULFASE ALFA 1MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

5ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ENZYMES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0155870001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2014-07-02

Charakterystyka produktu

_Vimizim (elosulfase alfa) Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
VIMIZIM
®
(elosulfase alfa)
Solution for Intravenous Infusion
5 mg/5 mL (1 mg/mL)
Enzyme Replacement Therapy
ATC Code: A16AB12
BioMarin International Limited
Shanbally, Ringaskiddy
County Cork, Ireland
www.bmrn.com
DISTRIBUTOR:
BioMarin Pharmaceutical (Canada) Inc.
Toronto, ON
Canada M5H 3C2
www.bmrn.com
Submission Control No: 194707
Date of Approval: July 14, 2016
_Vimizim (elosulfase alfa) Product Monograph _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS
.......................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
.........................