ZINBRYTA SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

DACLIZUMAB BETA

Διαθέσιμο από:

BIOGEN CANADA INC

Φαρμακολογική κατηγορία (ATC):

L04AC01

INN (Διεθνής Όνομα):

DACLIZUMAB

Δοσολογία:

150MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

DACLIZUMAB BETA 150MG

Οδός χορήγησης:

SUBCUTANEOUS

Μονάδες σε πακέτο:

3X1ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

Immunomodulatory Agents

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2018-04-30

Αρχείο Π.Χ.Π.

_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