IXIARO SUSPENSION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

INACT.JAPANESE ENCEPHAL VIRUS(ATTENUAT. STRAIN SA14-14-2 PRODUCED IN VERO CELLS)

Tilgjengelig fra:

VALNEVA AUSTRIA GMBH

ATC-kode:

J07BA02

INN (International Name):

ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS

Dosering :

6MCG

Legemiddelform:

SUSPENSION

Sammensetning:

INACT.JAPANESE ENCEPHAL VIRUS(ATTENUAT. STRAIN SA14-14-2 PRODUCED IN VERO CELLS) 6MCG

Administreringsrute:

INTRAMUSCULAR

Enheter i pakken:

0.5ML

Resept typen:

Schedule D

Terapeutisk område:

VACCINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0152652001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2013-10-08

Preparatomtale

_ _
_Appendix I - Product Monograph Template - Schedule D _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IXIARO
*
Japanese encephalitis vaccine (inactivated, adsorbed)
Suspension for injection
Active immunization agent for the prevention of Japanese encephalitis
Valneva Austria GmbH
Campus Vienna Biocenter 3
A-1030 Vienna
Austria
Imported by:
Quality & Compliance Services Inc.
Mississauga
ON L5N 5R1
Manufactured for:
Valneva Canada Inc.
Kirkland
QC H9H 5B9
SUBMISSION CONTROL NO: 203520 DATE OF APPROVAL: MARCH 2, 2018
_ _
_Appendix I - Product Monograph Template - Schedule D _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
Indication, Paediatrics
March, 2018
Dosage and Administration
March, 2018
Dosage forms, strenghts, composition and packaging
March, 2018
Warnings and Precautions, Special Populations
March, 2018
Special Handling Instructions
March, 2018
_ _
_Appendix I - Product Monograph Template - Schedule D _
_Page 3 of 57_
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES ......................................................................................
2
TABLE OF CONTENTS ...............................................................................................................
3
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 5
1
INDICATIONS
...................................................................................................................
5
1.1
Pediatrics
....................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................... 5
4
DOSAGE AND ADMINISTRATION
..............................................................................
6
4.1
Dosing Considerations
...............................................................................................
6
4.2