ZENAPAX 5MG/ML LIQUID
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-05-2007
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Active ingredient:
DACLIZUMAB
Available from:
HOFFMANN-LA ROCHE LIMITED
ATC code:
L04AC01
INN (International Name):
DACLIZUMAB
Dosage:
5MG
Pharmaceutical form:
LIQUID
Composition:
DACLIZUMAB 5MG
Administration route:
INTRAVENOUS
Units in package:
5 ML
Prescription type:
Prescription
Therapeutic area:
IMMUNOSUPPRESSIVE AGENTS
Product summary:
Active ingredient group (AIG) number: 0139502001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2011-10-17
Summary of Product characteristics
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_Page 1 of 32_
PRODUCT MONOGRAPH
PR
ZENAPAX
®
daclizumab
Liquid Concentrate For Infusion
25 mg/5 mL
professed standard
Immunosuppressant
Hoffmann-La Roche Limited
2455 Meadowpine Blvd.
Mississauga, Ontario
L5N 6L7
www.rochecanada.com
Date of Preparation:
January 4, 2000
Date of Approval:
May 25, 2007
Submission Control No: 112206
®
Registered Trade-Mark of Hoffmann-La Roche Limited
©
Copyright 2001 - 2007 Hoffmann-La Roche Limited
CDS Version 2.0
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_Page 2 of 32_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
................................................................................................13
DOSAGE AND
ADMINISTRATION..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY..........................................................................................17
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTICAL INFORMATION
......................................................................18
CLINICAL
TRIALS.......................................................................................................
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