SAXENDA SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

LIRAGLUTIDE

Disponible des:

NOVO NORDISK CANADA INC

Codi ATC:

A10BJ02

Designació comuna internacional (DCI):

LIRAGLUTIDE

Dosis:

6MG

formulario farmacéutico:

SOLUTION

Composición:

LIRAGLUTIDE 6MG

Vía de administración:

SUBCUTANEOUS

Unidades en paquete:

3X3ML/5X3ML

tipo de receta:

Prescription

Área terapéutica:

INCRETIN MIMETICS

Resumen del producto:

Active ingredient group (AIG) number: 0152718001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2015-02-24

Fitxa tècnica

_SAXENDA_
_®_
_ (liraglutide) Monograph – Schedule D _
_Page 1 of 53 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SAXENDA
®
liraglutide injection
6 mg/mL
Solution for Injection in a pre-filled pen
Human Glucagon Like Peptide-1 (GLP-1)
Weight Management
Novo Nordisk Canada Inc.
101-2476 Argentia Road
Mississauga, Ontario
L5N 6M1
Date of Initial Approval:
February 26, 2015
Date of Revision:
Submission Control No: 266069
_ _
_Saxenda_
_®_
_ (liraglutide injection) Monograph – Schedule D _
_Page 2 of 53_
RECENT MAJOR LABEL CHANGES
8.2 Clinical Trial Adverse Reactions
March 2021
Patient Medication Information
March 2021
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not
listed.
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
.....................................................................................................
5
2
CONTRAINDICATIONS
.......................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................ 6
4
DOSAGE AND ADMINISTRATION
.....................................................................
6
4.1
Dosing
Considerations.................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
............................................ 6
4.4
Administration
..............................................................................................
7