LIPRELOG SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INSULIN LISPRO

Available from:

ELI LILLY CANADA INC

ATC code:

A10AB04

INN (International Name):

INSULIN LISPRO

Dosage:

100UNIT

Pharmaceutical form:

SOLUTION

Composition:

INSULIN LISPRO 100UNIT

Administration route:

SUBCUTANEOUS

Units in package:

100

Prescription type:

Schedule D

Therapeutic area:

INSULINS

Product summary:

Active ingredient group (AIG) number: 0131614001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-03-22

Summary of Product characteristics

_LIPRELOG _
_Page 1 of 44 _
_ _
PRODUCT MONOGRAPH
LIPRELOG
™
(insulin lispro injection)
Solution for Injection, 100 units/mL, Lilly Standard
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 NO: 244445
DATE OF INITIAL APPROVAL:
March 22, 2021
_LIPRELOG _
_Page 2 of 44 _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
...............................................................................................
3
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
9
DRUG INTERACTIONS
..............................................................................................
11
DOSAGE AND ADMINISTRATION
...........................................................................
12
OVERDOSAGE
............................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 14
STORAGE AND STABILITY
......................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 19
PART II: SCIENTIFIC INFORMATION
............................................................................
20
PHARMACEUTICAL
INFORMATION.......................................................................
20
DETAILED PHARMACOLOGY
.................................................................................
21
TOXICOLOGY
................