REBINYN POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED

Доступно од:

NOVO NORDISK CANADA INC

АТЦ код:

B02BD04

INN (Међународно име):

COAGULATION FACTOR IX

Дозирање:

500UNIT

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 500UNIT

Пут администрације:

INTRAVENOUS

Јединице у пакету:

500 IU VIAL

Тип рецептора:

Schedule D

Терапеутска област:

HEMOSTATICS

Резиме производа:

Active ingredient group (AIG) number: 0159770001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2017-11-29

Карактеристике производа

_Rebinyn_
_®_
_ (Coagulation Factor IX (Recombinant), pegylated) Product Monograph _
_ Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
REBINYN®
Coagulation Factor IX (Recombinant), pegylated
nonacog beta pegol
Lyophilized powder for solution, 500, 1000, 2000 and 3000 IU/vial,
intravenous
Blood Coagulation Factor IX
Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1 Canada
Date of Initial Authorization:
Nov 29, 2017
Date of Revision:
Nov 22, 2022
Submission Control Number: 263051
_Rebinyn_
_®_
_ (Coagulation Factor IX (Recombinant), pegylated) Product Monograph _
_ Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
1INDICATIONS, 1.1 Pediatrics
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
09/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
..................................................................................................2
TABLE OF CONTENTS
..................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................4
1
INDICATIONS
..................................................................................................................4
1.1
Pediatrics..............................................................................................................4
2
CONTRAINDICATIONS......................................................................................................4
4
DOSAGE AND ADMINISTRATION
.......................................................................................4
4.1
Dosing Considerations
............................................................................................4
4.2
Recommended Dose and Dosage Adjustment
............................................................5
4.3
Reconstitution
.......................................................................................................6
4.4
Administration.............................