देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
ANTIHEMOPHILIC FACTOR (RECOMBINANT)
BAYER INC
B02BD02
COAGULATION FACTOR VIII
1000UNIT
POWDER FOR SOLUTION
ANTIHEMOPHILIC FACTOR (RECOMBINANT) 1000UNIT
INTRAVENOUS
2.5ML
Schedule D
HEMOSTATICS
Active ingredient group (AIG) number: 0124180002; AHFS:
CANCELLED POST MARKET
2018-10-01
_ _ _KOGENATE FS Product Monograph_ _Page 1 of 31 _ PRODUCT MONOGRAPH KOGENATE ® FS Antihemophilic Factor (Recombinant) _Formulated with Sucrose _ With Vial Adapter IV Injection, 250, 500, 1000, 2000, 3000 IU/vial Coagulation Factor Bayer Inc. 77 Belfield Road Toronto, Ontario M9W 1G6 Canada www.bayer.ca Date of Revision: November 15, 2013 SUBMISSION CONTROL NO: 159265 DATE OF APPROVAL: MAY 30, 2014 2013, Bayer Inc. ® KOGENATE, Bayer, and Bayer Cross are registered trademarks of Bayer AG, used under license by Bayer Inc. _ _ _KOGENATE FS Product Monograph_ _Page 2 of 31 _ 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 ......................................................................................... 5 ADVERSE REACTIONS ........................................................................................................... 7 DRUG INTERACTIONS ........................................................................................................... 9 DOSAGE AND ADMINISTRATION ..................................................................................... 10 OVERDOSAGE ........................................................................................................................ 16 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 16 STORAGE AND STABILITY ................................................................................................. 17 SPECIA पूरा दस्तावेज़ पढ़ें