FEIBA NF KIT

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ANTI-INHIBITOR COAGULANT COMPLEX

Saatavilla:

TAKEDA CANADA INC

ATC-koodi:

B02BD03

INN (Kansainvälinen yleisnimi):

FACTOR VIII INHIBITOR BYPASSING ACTIVITY

Annos:

650UNIT

Lääkemuoto:

KIT

Koostumus:

ANTI-INHIBITOR COAGULANT COMPLEX 650UNIT

Antoreitti:

INTRAVENOUS

Kpl paketissa:

20 ML

Prescription tyyppi:

Schedule D

Terapeuttinen alue:

HEMOSTATICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0133136001; AHFS:

Valtuutuksen tilan:

CANCELLED PRE MARKET

Valtuutus päivämäärä:

2023-08-09

Valmisteyhteenveto

_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
...................................