NOVORAPID SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

INSULIN ASPART

Tersedia dari:

NOVO NORDISK CANADA INC

Kode ATC:

A10AB05

INN (Nama Internasional):

INSULIN ASPART

Dosis:

100UNIT

Bentuk farmasi:

SOLUTION

Komposisi:

INSULIN ASPART 100UNIT

Rute administrasi :

SUBCUTANEOUS

Unit dalam paket:

3 ML

Jenis Resep:

Schedule D

Area terapi:

INSULINS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2001-07-18

Karakteristik produk

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