REBINYN POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED

Dostupno od:

NOVO NORDISK CANADA INC

ATC koda:

B02BD04

INN (International ime):

COAGULATION FACTOR IX

Doziranje:

2000UNIT

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

COAGULATION FACTOR IX (RECOMBINANT), PEGYLATED 2000UNIT

Administracija rute:

INTRAVENOUS

Jedinice u paketu:

2000 IU VIAL

Tip recepta:

Schedule D

Područje terapije:

HEMOSTATICS

Proizvod sažetak:

Active ingredient group (AIG) number: 0159770003; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2017-11-29

Svojstava lijeka

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