FEIBA NF KIT

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

ANTI-INHIBITOR COAGULANT COMPLEX

可用日期:

TAKEDA CANADA INC

ATC代码:

B02BD03

INN（国际名称）:

FACTOR VIII INHIBITOR BYPASSING ACTIVITY

剂量:

3250UNIT

药物剂型:

KIT

组成:

ANTI-INHIBITOR COAGULANT COMPLEX 3250UNIT

给药途径:

INTRAVENOUS

每包单位数:

50ML

处方类型:

Schedule D

治疗领域:

HEMOSTATICS

產品總結:

Active ingredient group (AIG) number: 0133136003; AHFS:

授权状态:

APPROVED

授权日期:

2015-04-20

产品特点

_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
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RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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