Land: Kanada
Språk: engelska
Källa: Health Canada
TICK-BORNE ENCEPHALITIS VACCINE (INACTIVATED)
BAXTER CORPORATION
J07BA01
ENCEPHALITIS, TICK BORNE, INACTIVATED, WHOLE VIRUS
2.4MCG
SUSPENSION
TICK-BORNE ENCEPHALITIS VACCINE (INACTIVATED) 2.4MCG
INTRAMUSCULAR
0.5ML
Schedule D
VACCINES
Active ingredient group (AIG) number: 0150541001; AHFS:
CANCELLED POST MARKET
2014-03-03
_ _ _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................................................................................. Läs hela dokumentet