VARIZIG KIT

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN)

Disponible des:

CANGENE CORPORATION A SUBSIDIARY OF EMERGENT BIOSOLUTIONS INC.

Codi ATC:

J06BB03

Designació comuna internacional (DCI):

VARICELLA/ZOSTER IMMUNOGLOBULIN

Dosis:

125UNIT

formulario farmacéutico:

KIT

Composición:

VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN) 125UNIT

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

6ML

tipo de receta:

Schedule D

Área terapéutica:

SERUMS

Resumen del producto:

Active ingredient group (AIG) number: 0115174003; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2016-08-02

Fitxa tècnica

_ _
_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