ZINBRYTA SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DACLIZUMAB BETA

Prieinama:

BIOGEN CANADA INC

ATC kodas:

L04AC01

INN (Tarptautinis Pavadinimas):

DACLIZUMAB

Dozė:

150MG

Vaisto forma:

SOLUTION

Sudėtis:

DACLIZUMAB BETA 150MG

Vartojimo būdas:

SUBCUTANEOUS

Vienetai pakuotėje:

1ML

Recepto tipas:

Prescription

Gydymo sritis:

Immunomodulatory Agents

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED PRE MARKET

Leidimo data:

2018-05-30

Prekės savybės

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_07 September 2018 _
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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 Initial Approval:
December 16, 2016
Date of Revision:
November 15, 2018
Submission Control No: 220549
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_07 September 2018 _
_Page 2 of 55_
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
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................16
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC