MOUNJARO SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TIRZEPATIDE

Dostupné z:

ELI LILLY CANADA INC

ATC kód:

A10BX16

INN (Medzinárodný Name):

TIRZEPATIDE

Dávkovanie:

5MG

Forma lieku:

SOLUTION

Zloženie:

TIRZEPATIDE 5MG

Spôsob podávania:

SUBCUTANEOUS

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Prehľad produktov:

Active ingredient group (AIG) number: 0164301002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2023-08-31

Súhrn charakteristických

_MOUNJARO (tirzepatide injection) _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MOUNJARO
®
tirzepatide injection
Solution, 2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL,
12.5 mg/0.5 mL, 15 mg/0.5 mL, in a
single-dose prefilled pen or single-dose vial for subcutaneous use
Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like
Peptide-1 (GLP-1) Receptor Agonist
Antihyperglycemic Agent
Eli Lilly Canada Inc.
Exchange Tower
130 King Street West, Suite 900
P.O. Box 73
Toronto, Ontario
M5X 1B1
1-888-545-5972
www.lilly.ca
Date of Initial Authorization:
NOV 23, 2022
Date of Revision:
NOV 01,2023
Submission Control Number: 276224
MOUNJARO is a registered trademark owned by or licensed to Eli Lilly
and Company, its subsidiaries or
affiliates.
_MOUNJARO (tirzepatide injection) _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
11/2023
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
.................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
........................