ZINBRYTA SOLUTION

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

DACLIZUMAB BETA

Saadav alates:

BIOGEN CANADA INC

ATC kood:

L04AC01

INN (Rahvusvaheline Nimetus):

DACLIZUMAB

Annus:

150MG

Ravimvorm:

SOLUTION

Koostis:

DACLIZUMAB BETA 150MG

Manustamisviis:

SUBCUTANEOUS

Ühikuid pakis:

3X1ML

Retsepti tüüp:

Prescription

Terapeutiline ala:

Immunomodulatory Agents

Toote kokkuvõte:

Active ingredient group (AIG) number: 0158650001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2018-04-30

Toote omadused

_28 January 2018_
_Page 1 of 54_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ZINBRYTA™
Daclizumab beta
Solution for injection, 150 mg/mL
Immunomodulator
ZINBRYTA
TM
SHOULD BE USED BY PHYSICIANS WHO HAVE SUFFICIENT KNOWLEDGE OF MULTIPLE
SCLEROSIS AND WHO HAVE FAMILIARISED THEMSELVES WITH THE
EFFICACY/SAFETY PROFILE OF
ZINBRYTA
TM
.
Biogen Canada Inc.
90 Burnhamthorpe Road West, Suite 1100
Mississauga, Ontario
L5B 3C3
Date of Preparation:
16 December 2016
Date of Revision:
28 January 2018
Submission Control No: 213583
Date of Authorization: 07 March 2018
_28 January 2018_
_Page 2 of 54_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................9
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND
ADMINISTRATION..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND
STABILITY..........................................................................................20
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SC