SOLIQUA SOLUTION

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

INSULIN GLARGINE; LIXISENATIDE

Tillgänglig från:

SANOFI-AVENTIS CANADA INC

ATC-kod:

A10AE54

INN (International namn):

INSULIN GLARGINE AND LIXISENATIDE

Dos:

100UNIT; 33MCG

Läkemedelsform:

SOLUTION

Sammansättning:

INSULIN GLARGINE 100UNIT; LIXISENATIDE 33MCG

Administreringssätt:

SUBCUTANEOUS

Enheter i paketet:

15G/50G

Receptbelagda typ:

Prescription

Terapiområde:

INSULINS

Produktsammanfattning:

Active ingredient group (AIG) number: 0260350001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2018-07-06

Produktens egenskaper

_Product Monograph Master Template _
_Template Date: _
_SOLIQUA_
_Insulin glargine and Lixisenatide injection _
_Page 1 of 66_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SOLIQUA®
Insulin glargine and Lixisenatide injection
100 units/mL + 33 mcg/mL
Solution for injection in a prefilled pen for subcutaneous injection
Antidiabetic Agent
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
www.sanofi.ca
Date of Initial Authorization:
JUL 06, 2018
Date of Revision:
JUN 28, 2023
Submission Control Number: 271298
_Product Monograph Master Template _
_Template Date: _
_SOLIQUA Insulin glargine and Lixisenatide injection _
_Page 2 of 66_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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
..............................................................5
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................6
4.4
Administration
.....................................................................................................9
4.5
Missed Dose
............