País: Canadá
Língua: inglês
Origem: Health Canada
TIRZEPATIDE
ELI LILLY CANADA INC
A10BX16
TIRZEPATIDE
5MG
SOLUTION
TIRZEPATIDE 5MG
SUBCUTANEOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0164301002; AHFS:
APPROVED
2023-08-31
_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 ........................ Leia o documento completo