VARIZIG KIT
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
03-10-2014
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Aktiv ingrediens:
VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN)
Tilgjengelig fra:
CANGENE CORPORATION A SUBSIDIARY OF EMERGENT BIOSOLUTIONS INC.
ATC-kode:
J06BB03
INN (International Name):
VARICELLA/ZOSTER IMMUNOGLOBULIN
Dosering :
125UNIT
Legemiddelform:
KIT
Sammensetning:
VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN) 125UNIT
Administreringsrute:
INTRAMUSCULAR
Enheter i pakken:
6ML
Resept typen:
Schedule D
Terapeutisk område:
SERUMS
Produkt oppsummering:
Active ingredient group (AIG) number: 0115174003; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2016-08-02
Preparatomtale
_ _
_VariZIG™ Product Monograph _
_Page 1 of 25_
PRODUCT MONOGRAPH
VARIZIG
™
Varicella Zoster Immune Globulin (Human)
Powder for Injection 125 IU/vial
World Health Organization (WHO) Anti-Varicella Zoster
Immune Globulin, International Reference Standard
Passive Immunizing Agent
Cangene Corporation
155 Innovation Drive
Winnipeg, MB
R3T 5Y3
Canada
www.cangene.com
Control No #: 117221 Date of Approval: January 9, 2008
_ _
_VariZIG™ Product Monograph _
_Page 2 of 25_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
5
ADVERSE
REACTIONS...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
10
DOSAGE AND
ADMINISTRATION.............................................................................
11
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND
STABILITY.........................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
......................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC
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