IXIARO SUSPENSION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

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

Boleh didapati daripada:

VALNEVA AUSTRIA GMBH

Kod ATC:

J07BA02

INN (Nama Antarabangsa):

ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS

Dos:

6MCG

Borang farmaseutikal:

SUSPENSION

Komposisi:

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

Laluan pentadbiran:

INTRAMUSCULAR

Unit dalam pakej:

0.5ML

Jenis preskripsi:

Schedule D

Kawasan terapeutik:

VACCINES

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2013-10-08

Ciri produk

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_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
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_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