XULTOPHY SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INSULIN DEGLUDEC; LIRAGLUTIDE

Available from:

NOVO NORDISK CANADA INC

ATC code:

A10AE56

INN (International Name):

INSULIN DEGLUDEC AND LIRAGLUTIDE

Dosage:

100UNIT; 3.6MG

Pharmaceutical form:

SOLUTION

Composition:

INSULIN DEGLUDEC 100UNIT; LIRAGLUTIDE 3.6MG

Administration route:

SUBCUTANEOUS

Units in package:

1X3ML/3X3ML/5X3ML

Prescription type:

Prescription

Therapeutic area:

INSULINS

Product summary:

Active ingredient group (AIG) number: 0260170001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-04-11

Summary of Product characteristics

_Product Monograph Master Template _
_Template Date: September 2020 _
_XULTOPHY_
_® _
_(insulin degludec+liraglutide injection) _
_Page 1 of 66 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION XULTOPHY
®
insulin degludec + liraglutide injection
100 units/mL + 3.6 mg/mL
Solution for injection in a pre-filled pen
Subcutaneous use
House Standard
Antidiabetic agent
ATC Code: A10AE56
Novo Nordisk Canada Inc.
101 - 2476 Argentia Road
Mississauga, Ontario
Canada, L5N 6M1
Date of Initial Authorization:
APR 11,2018
Date of Revision:
SEP 15, 2023
Submission Control Number: 274449
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
XULTOPHY
®
(insulin degludec+liraglutide injection)
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
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
.........................................................................................................
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
.......................................................