TOUJEO SOLOSTAR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INSULIN GLARGINE

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

A10AE04

INN (International Name):

INSULIN GLARGINE

Dosage:

300UNIT

Pharmaceutical form:

SOLUTION

Composition:

INSULIN GLARGINE 300UNIT

Administration route:

SUBCUTANEOUS

Units in package:

3X1.5ML/ 5X1.5ML

Prescription type:

Schedule D

Therapeutic area:

INSULINS

Product summary:

Active ingredient group (AIG) number: 0147062002; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-05-28

Summary of Product characteristics

_Page 1 of 88 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TOUJEO
® SOLOSTAR
®
TOUJEO
® DOUBLESTAR
®
Insulin glargine (rDNA origin)
Solution for injection 300 U/mL
Antidiabetic Agent
Long-acting Recombinant Human Insulin Analogue
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Approval:
May 28, 2015
Submission Control No: 228382
Date of Revision:
May 12, 2020
_Page 2 of 88 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................ 3
SUMMARY PRODUCT INFORMATION
..........................................................................
3
DESCRIPTION
.....................................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
4
WARNINGS AND
PRECAUTIONS....................................................................................
4
ADVERSE REACTIONS
...................................................................................................
11
DRUG INTERACTIONS
....................................................................................................
19
DOSAGE AND ADMINISTRATION
................................................................................
20
OVERDOSAGE
..................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 24
STORAGE AND
STABILITY............................................................................................
27
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
27
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 29
PART II: SCIENTIFIC