WILATE POWDER FOR SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ANTIHEMOPHILIC FACTOR (HUMAN); VON WILLEBRAND FACTOR (HUMAN); HUMAN PLASMA PROTEINS

Boleh didapati daripada:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H

Kod ATC:

B02BD06

INN (Nama Antarabangsa):

VON WILLEBRAND FACTOR AND COAG. FACT. VIII IN COMB

Dos:

1000UNIT; 1000UNIT; 15MG

Borang farmaseutikal:

POWDER FOR SOLUTION

Komposisi:

ANTIHEMOPHILIC FACTOR (HUMAN) 1000UNIT; VON WILLEBRAND FACTOR (HUMAN) 1000UNIT; HUMAN PLASMA PROTEINS 15MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

10ML

Jenis preskripsi:

Schedule D

Kawasan terapeutik:

HEMOSTATICS

Ringkasan produk:

Active ingredient group (AIG) number: 0351695002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2006-10-04

Ciri produk

_wilate_
_® _
_January 2024 _
_Human von Willebrand factor (VWF) and human Coagulation Factor VIII
(FVIII) _
_Page 1 of 38_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
WILATE
®
Human von Willebrand factor (VWF) and human Coagulation Factor VIII
(FVIII) for Injection
Powder and solvent for solution for injection
500 IU VWF and 500 IU FVIII reconstituted with 5 mL of diluent
1000 IU VWF and 1000 IU FVIII reconstituted with 10 mL of diluent
intravenous injection
Prescribed Standard
ATC-Code: B02BD06 D68.0
Anti-hemorrhagic blood coagulation factors
Manufactured by:
Date of Initial Authorization:
Octapharma Pharmazeutika Produktionsges m.b.H.
OCT 04, 2006
Oberlaaer Strasse 235
A-1100 Vienna, Austria
Date of Revision:
FEB 27, 2024
Manufactured for:
Octapharma Canada, Inc.
1000-25 King St W
Toronto, ON M5L 1G1, Canada
Submission Control Number: 274244
_wilate_
_® _
_January 2024 _
_Human von Willebrand factor (VWF) and human Coagulation Factor VIII
(FVIII) _
_Page 2 of 38_
_ _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
1/2024
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
1/2024
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
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
......................................................