IXIARO SUSPENSION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

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

Διαθέσιμο από:

VALNEVA AUSTRIA GMBH

Φαρμακολογική κατηγορία (ATC):

J07BA02

INN (Διεθνής Όνομα):

ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS

Δοσολογία:

6MCG

Φαρμακοτεχνική μορφή:

SUSPENSION

Σύνθεση:

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

Οδός χορήγησης:

INTRAMUSCULAR

Μονάδες σε πακέτο:

0.5ML

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

VACCINES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-10-08

Αρχείο Π.Χ.Π.

_ _
_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