NOVOMIX 30 SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INSULIN ASPART; INSULIN ASPART PROTAMINE

Available from:

NOVO NORDISK CANADA INC

ATC code:

A10AD05

INN (International Name):

INSULIN ASPART

Dosage:

30UNIT; 70UNIT

Pharmaceutical form:

SUSPENSION

Composition:

INSULIN ASPART 30UNIT; INSULIN ASPART PROTAMINE 70UNIT

Administration route:

SUBCUTANEOUS

Units in package:

3ML

Prescription type:

Schedule D

Therapeutic area:

INSULINS

Product summary:

Active ingredient group (AIG) number: 0252426004; AHFS:

Authorization status:

APPROVED

Authorization date:

2005-02-25

Summary of Product characteristics

_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_NOVOMIX_
_®_
_ 30 (30% soluble insulin aspart, 70% insulin aspart protamine
crystals) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Schedule D
NovoMix
®
30
(30% soluble insulin aspart, 70% insulin aspart protamine crystals)
Suspension for Injection, 100 Units/mL
Subcutaneous injection
Professed
Antidiabetic Agent
ATC code: A10AD05
long-acting combined with fast-acting
NOVO NORDISK CANADA INC.
2476 Argentia Road
Mississauga, Ontario
L5N 6M1 Canada
Date of Initial Authorization:
JUL 11, 2017
Date of Revision:
AUG 12, 2021
Submission Control Number: 250686
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_NOVOMIX_
_®_
_ 30 (30% soluble insulin aspart, 70% insulin aspart protamine
crystals) _
_Page 2 of 38_
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
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
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
..............................................