NIASTASE RT KIT

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

EPTACOG ALFA (ACTIVATED)

Sẵn có từ:

NOVO NORDISK CANADA INC

Mã ATC:

B02BD08

INN (Tên quốc tế):

COAGULATION FACTOR VIIa

Liều dùng:

5MG

Dạng dược phẩm:

KIT

Thành phần:

EPTACOG ALFA (ACTIVATED) 5MG

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

5MG/5.2ML

Loại thuốc theo toa:

Schedule D

Khu trị liệu:

HEMOSTATICS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0136061003; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2018-01-19

Đặc tính sản phẩm

_NIASTASE RT_
®
_ _
_Product Monograph _
Page 1
PRODUCT MONOGRAPH
Schedule D
NIASTASE RT
®
eptacog alfa (activated)
Activated Recombinant Human Blood Coagulation Factor VII
Room Temperature Stable
Lyophilized Powder
1.0 mg per vial (50 KIU/vial)
2.0 mg per vial (100 KIU/vial)
5.0 mg per vial (250 KIU/vial)
8.0 mg per vial (400 KIU/vial)
Professed
Coagulation Factor
NOVO NORDISK CANADA INC.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1 Canada
DATE OF REVISION:
October 01, 2018
Submission Control No: 220117
_NIASTASE RT_
®
_ _
_Product Monograph _
Page 2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..............................................3
SUMMARY PRODUCT INFORMATION
..........................................................3
DESCRIPTION
.....................................................................................................3
INDICATIONS AND CLINICAL USE
................................................................3
CONTRAINDICATIONS
.....................................................................................4
WARNINGS AND
PRECAUTIONS....................................................................4
ADVERSE
REACTIONS......................................................................................8
DRUG INTERACTIONS
....................................................................................15
DOSAGE AND ADMINISTRATION
................................................................16
OVERDOSAGE
..................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
..............................................21
STORAGE AND
STABILITY............................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................23
PART II: SCIENTIFIC INFORMATION
....................................................................25
PHARMACEUTICAL
INFORMATION............................................................25
CLINICAL TRIAL