VARIZIG KIT

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN)

Tersedia dari:

CANGENE CORPORATION A SUBSIDIARY OF EMERGENT BIOSOLUTIONS INC.

Kode ATC:

J06BB03

INN (Nama Internasional):

VARICELLA/ZOSTER IMMUNOGLOBULIN

Dosis:

125UNIT

Bentuk farmasi:

KIT

Komposisi:

VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN) 125UNIT

Rute administrasi :

INTRAMUSCULAR

Unit dalam paket:

6ML

Jenis Resep:

Schedule D

Area terapi:

SERUMS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2016-08-02

Karakteristik produk

_ _
_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