HUMULIN N (KWIKPEN) SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INSULIN ISOPHANE HUMAN BIOSYNTHETIC

Available from:

ELI LILLY CANADA INC

ATC code:

A10AC01

INN (International Name):

INSULIN (HUMAN)

Dosage:

100UNIT

Pharmaceutical form:

SUSPENSION

Composition:

INSULIN ISOPHANE HUMAN BIOSYNTHETIC 100UNIT

Administration route:

SUBCUTANEOUS

Units in package:

3 ML

Prescription type:

Schedule D

Therapeutic area:

INSULINS

Product summary:

Active ingredient group (AIG) number: 0123341001; AHFS:

Authorization status:

MARKETED

Authorization date:

2013-09-13

Summary of Product characteristics

_HUMULIN Product Monograph _
_ _
_Page 1 of 54_
PRODUCT MONOGRAPH
HUMULIN
® R
(insulin, human biosynthetic)
Solution for Injection, 100 units/mL
ATC Code: A10AB01
fast-acting
HUMULIN
® N
(insulin isophane, human biosynthetic, rDNA origin)
Suspension for Injection, 100 units/mL
ATC Code: A10AC01
intermediate-acting
HUMULIN
® 30/70
(30% insulin injection, 70% insulin isophane, human biosynthetic, rDNA
origin)
Suspension for Injection, 100 units/mL
ATC Code: A10AD01
intermediate- or long-acting combined with fast-acting
THERAPEUTIC CLASSIFICATION
ANTI-DIABETIC AGENT

Eli Lilly Canada Inc.
Exchange Tower
130 King Street West, Suite 900
P.O. Box 73
Toronto, Ontario
M5X 1B1
Submission Control
№
245812
Date of Initial Approval:
December 31, 1983
Date of Revision:
March 26, 2021
_HUMULIN Product Monograph _
_ _
_Page 2 of 54_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
...............................................................................................
9
DRUG INTERACTIONS
...............................................................................................
9
DOSAGE AND ADMINISTRATION
..........................................................................
10
OVERDOSAGE
...........................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 12
STORAGE AND STABILITY
.....................................................................................
13
SPEC