Страна: Канада
мова: англійська
Джерело: Health Canada
ANTI-INHIBITOR COAGULANT COMPLEX
TAKEDA CANADA INC
B02BD03
FACTOR VIII INHIBITOR BYPASSING ACTIVITY
1300UNIT
KIT
ANTI-INHIBITOR COAGULANT COMPLEX 1300UNIT
INTRAVENOUS
20ML
Schedule D
HEMOSTATICS
Active ingredient group (AIG) number: 0133136002; AHFS:
APPROVED
2018-09-04
_FEIBA NF Product Monograph _ _Date: November 2020 _ _Page 1 of 33_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION FEIBA ® NF Anti-Inhibitor Coagulant Complex Freeze-Dried Powder with Solvent for Intravenous Injection or Infusion, 350-650 Units per 10 mL or 20 mL, 700-1300 Units per 20 mL, 1750-3250 Units per 50 mL Hemostatic Human Plasma Fraction with Factor VIII Inhibitor Bypassing Activity Takeda Canada Inc. 22 Adelaide St. West, Suite 3800 Toronto, Ontario M5H 4E3 Date of Initial Approval: JUN 18, 2019 Date of Revision: DEC 29, 2020 Submission Control No: 241701 FEIBA ® is a registered trademark of Baxalta Incorporated, a Takeda company. Takeda® and the Takeda Logo are trademarks of Takeda Pharmaceutical Company Limited, used under license. _ _ _FEIBA NF [Anti-Inhibitor Coagulant Complex] Product Monograph _ _Date: November 2020 _ _Page 2 of 33_ RECENT MAJOR LABEL CHANGES All Sections – Conversion to June 2017 Template Jun, 2020 TABLE OF CONTENTS [To update, right-click anywhere in the Table of Contents and select “Update Field”, “Update entire table”, click OK.] RECENT MAJOR LABEL CHANGES ........................................................................................ 2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS ................................................................................................................. 4 1.1 Pediatrics ............................................................................................................... 4 1.2 Geriatrics ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................... Прочитайте повний документ