NOVOLIN GE 50/50 PENFILL SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INSULIN INJECTION HUMAN BIOSYNTHETIC; INSULIN ISOPHANE HUMAN BIOSYNTHETIC

Available from:

NOVO NORDISK CANADA INC

ATC code:

A10AD01

INN (International Name):

INSULIN (HUMAN)

Dosage:

50UNIT; 50UNIT

Pharmaceutical form:

SUSPENSION

Composition:

INSULIN INJECTION HUMAN BIOSYNTHETIC 50UNIT; INSULIN ISOPHANE HUMAN BIOSYNTHETIC 50UNIT

Administration route:

SUBCUTANEOUS

Units in package:

3ML

Prescription type:

Schedule D

Therapeutic area:

INSULINS

Product summary:

Active ingredient group (AIG) number: 0223312004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2023-03-31

Summary of Product characteristics

_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_NOVOLIN_
_®_
_GE Insulin, Human Biosynthetic _
_Page 1 of 62_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Schedule D
NOVOLIN
®
GE
Insulin, Human Biosynthetic
Injectable Solution/Suspension, 3.5 mg (100 IU)
Manufacturer’s Standard
Antidiabetic Agent
Novolin
®
GE Toronto ATC code: A10AB01, fast-acting
Novolin
®
GE NPH ATC code: A10AC01, intermediate-acting
Novolin
®
GE Premixed Insulin Preparations ATC code: A10AD01, intermediate- or
long-acting
combined with fast-acting
Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1
Date of Initial Authorization:
JAN 07, 2011
Date of Revision:
AUG 12, 2021
Submission Control Number: 251302
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_NOVOLIN_
_®_
_GE Insulin, Human Biosynthetic _
_Page 2 of 62_
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...........................................................................................................
5
2
CONTRAINDICATIONS
..............................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................... 5
4
DOSAGE AND ADMINISTRATI