IXIARO SUSPENSION

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

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

থেকে পাওয়া:

VALNEVA AUSTRIA GMBH

এটিসি কোড:

J07BA02

INN (International Name):

ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS

ডোজ:

6MCG

ফার্মাসিউটিকাল ফর্ম:

SUSPENSION

রচনা:

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

প্রশাসন রুট:

INTRAMUSCULAR

প্যাকেজ ইউনিট:

0.5ML

প্রেসক্রিপশন টাইপ:

Schedule D

Therapeutic area:

VACCINES

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2013-10-08

পণ্য বৈশিষ্ট্য

_ _
_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