NOVORAPID SOLUTION

国家: 加拿大

语言: 英文

来源: Health Canada

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12-08-2021

有效成分:

INSULIN ASPART

可用日期:

NOVO NORDISK CANADA INC

ATC代码:

A10AB05

INN(国际名称):

INSULIN ASPART

剂量:

100UNIT

药物剂型:

SOLUTION

组成:

INSULIN ASPART 100UNIT

给药途径:

SUBCUTANEOUS

每包单位数:

3ML

处方类型:

Schedule D

治疗领域:

INSULINS

產品總結:

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

授权状态:

CANCELLED POST MARKET

授权日期:

2023-08-16

产品特点

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