NOVORAPID SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

INSULIN ASPART

Sẵn có từ:

NOVO NORDISK CANADA INC

Mã ATC:

A10AB05

INN (Tên quốc tế):

INSULIN ASPART

Liều dùng:

100UNIT

Dạng dược phẩm:

SOLUTION

Thành phần:

INSULIN ASPART 100UNIT

Tuyến hành chính:

SUBCUTANEOUS

Các đơn vị trong gói:

10 ML

Loại thuốc theo toa:

Schedule D

Khu trị liệu:

INSULINS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0144802001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2001-07-18

Đặc tính sản phẩm

_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_NovoRapid_
_® _
_Insulin Aspart _
_Page 1 of 52_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
NOVORAPID
®
Insulin Aspart
Solution for Injection, 100 Units/mL, Subcutaneous Injection
Professed Standard
Anti-diabetic Agent
ATC code: A10AB05
fast-acting
Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1 Canada
Date of Initial Authorization:
APR 06, 2018
Date of Revision:
AUG 12, 2021
Submission Control Number: 251029
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_NovoRapid_
_® _
_Insulin Aspart _
_Page 2 of 52_
RECENT MAJOR LABEL CHANGES
4.4 Administration
03/2021
7 Warnings and Precautions
03/2021
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
1
INDICATIONS.............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................... 4
4
DOSAGE AND ADMINISTRATION
.............................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 5
4.4
Administration.........................