NOVORAPID SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

INSULIN ASPART

Disponible depuis:

NOVO NORDISK CANADA INC

Code ATC:

A10AB05

DCI (Dénomination commune internationale):

INSULIN ASPART

Dosage:

100UNIT

forme pharmaceutique:

SOLUTION

Composition:

INSULIN ASPART 100UNIT

Mode d'administration:

SUBCUTANEOUS

Unités en paquet:

3ML

Type d'ordonnance:

Schedule D

Domaine thérapeutique:

INSULINS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2023-08-16

Résumé des caractéristiques du produit

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