NUWIQ KIT

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

SIMOCTOCOG ALFA; WATER

Tersedia dari:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H

Kode ATC:

B02BD02

INN (Nama Internasional):

COAGULATION FACTOR VIII

Dosis:

2500UNIT; 2.5ML

Bentuk farmasi:

KIT

Komposisi:

SIMOCTOCOG ALFA 2500UNIT; WATER 2.5ML

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Schedule D

Area terapi:

HEMOSTATICS

Ringkasan produk:

Active ingredient group (AIG) number: 0256190005; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-03-20

Karakteristik produk

_ _
_Nuwiq Product Monograph _
_Page 1 of 42_
PRODUCT MONOGRAPH
Nuwiq
®
Antihemophilic
Factor (Recombinant, B-Domain deleted)
INN = simoctocog alfa
Powder and solvent for solution for intravenous injection
250 IU FVIII/vial reconstituted with 2.5 mL of solvent
500 IU FVIII/vial reconstituted with 2.5 mL of solvent
1000 IU FVIII/vial reconstituted with 2.5 mL of solvent
1500 IU FVIII/vial reconstituted with 2.5 mL of solvent
2000 IU FVIII/vial reconstituted with 2.5 mL of solvent
2500 IU FVIII/vial reconstituted with 2.5 mL of solvent
3000 IU FVIII/vial reconstituted with 2.5 mL of solvent
4000 IU FVIII/vial reconstituted with 2.5 mL of solvent
ATC code: B02BD02
Manufactured by:
Octapharma AB
Lars Forssells gata 23
112 75 Stockholm,
SWEDEN
Manufactured for:
Octapharma Canada Inc.
308-214 King St W
Toronto, Ontario, M5H 3S6, CANADA
Date of Initial Approval:
October 23, 2014
Date of Revision:
December 29, 2022
Control #: 264181
_ _
_Nuwiq Product Monograph _
_Page 2 of 42_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................ 3
SUMMARY PRODUCT INFORMATION
.............................................................. 3
DESCRIPTION
.......................................................................................................
3
INDICATIONS AND CLINICAL
USE....................................................................
4
CONTRAINDICATIONS
........................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................
4
ADVERSE REACTIONS
........................................................................................
6
DRUG
INTERACTIONS.........................................................................................
9
DOSAGE AND
ADMINISTRATION......................................................................
9
OVERDOSAGE
.....................................................................................................15
ACTI