FSME-IMMUN SUSPENSION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

TICK-BORNE ENCEPHALITIS VACCINE (INACTIVATED)

Tilgængelig fra:

BAXTER CORPORATION

ATC-kode:

J07BA01

INN (International Name):

ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS

Dosering:

2.4MCG

Lægemiddelform:

SUSPENSION

Sammensætning:

TICK-BORNE ENCEPHALITIS VACCINE (INACTIVATED) 2.4MCG

Indgivelsesvej:

INTRAMUSCULAR

Enheder i pakken:

0.5ML

Recept type:

Schedule D

Terapeutisk område:

VACCINES

Produkt oversigt:

Active ingredient group (AIG) number: 0150541001; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2014-03-03

Produktets egenskaber

_ _
_Appendix I - Product Monograph Template - Schedule D _
_Page 1 of 28_
PRODUCT MONOGRAPH
FSME-IMMUN
1
Tick-Borne Encephalitis Virus Vaccine, Inactivated, with Adjuvant
2.4 µg (target value)/0.5 mL
Sterile Suspension for Intramuscular Injection
Vaccine for the Prevention of Tick-Borne Encephalitis
Manufactured by:
BAXTER AG
A-1220 Vienna, Austria
Imported and Distributed by:
Date of Revisions:
BAXTER CORPORATION
April 13, 2011
Mississauga, Ontario
CANADA
SUBMISSION CONTROL NO: 145702
APPROVAL DATE: MAY 19, 2011
This Product Monograph is the exclusive property of Baxter
Corporation. It may not be copied in
whole or in part without the express permission of Baxter Corporation.
1
FSME-IMMUN is a trademark of Baxter AG, Vienna, Austria.
_ _
_Appendix I - Product Monograph Template - Schedule D _
_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
8
DOSAGE AND
ADMINISTRATION...............................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND
STABILITY.................................................................................