MOUNJARO SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

TIRZEPATIDE

から入手可能:

ELI LILLY CANADA INC

ATCコード:

A10BX16

INN（国際名）:

TIRZEPATIDE

投薬量:

12.5MG

医薬品形態:

SOLUTION

構図:

TIRZEPATIDE 12.5MG

投与経路:

SUBCUTANEOUS

パッケージ内のユニット:

100

処方タイプ:

Prescription

製品概要:

Active ingredient group (AIG) number: 0164301005; AHFS:

認証ステータス:

APPROVED

承認日:

2022-11-24

製品の特徴

_ _
_MOUNJARO (tirzepatide injection) _
_Page 1 of 45_
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 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
Submission Control Number: 259103
MOUNJARO is a trademark owned by or licensed to Eli Lilly and Company,
its subsidiaries or
affiliates.
_ _
_MOUNJARO (tirzepatide injection) _
_Page 2 of 45_
RECENT MAJOR LABEL CHANGES
None at time of authorization
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
..............................................................................
5
4.1
Dosing Considerations
...........