VARIZIG KIT

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN)

Pieejams no:

CANGENE CORPORATION A SUBSIDIARY OF EMERGENT BIOSOLUTIONS INC.

ATĶ kods:

J06BB03

SNN (starptautisko nepatentēto nosaukumu):

VARICELLA/ZOSTER IMMUNOGLOBULIN

Deva:

125UNIT

Zāļu forma:

KIT

Kompozīcija:

VARICELLA ZOSTER IMMUNOGLOBULIN (HUMAN) 125UNIT

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

6ML

Receptes veids:

Schedule D

Ārstniecības joma:

SERUMS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2016-08-02

Produkta apraksts

_ _
_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