Страна: Канада
Язык: английский
Источник: Health Canada
SEMAGLUTIDE
NOVO NORDISK CANADA INC
A10BJ06
SEMAGLUTIDE
1MG
SOLUTION
SEMAGLUTIDE 1MG
SUBCUTANEOUS
2 X2MG/PEN
Prescription
INCRETIN MIMETICS
Active ingredient group (AIG) number: 0159870001; AHFS:
APPROVED
2018-01-04
_Product Monograph Ozempic_ _®_ _ _ _semaglutide injection _ _Page 1 of 62_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR OZEMPIC ® semaglutide injection 2 mg/pen (0.68 mg/mL or 1.34 mg/mL) 4 mg/pen (1.34 mg/mL) 8 mg/pen (2.68 mg/mL) Pre-filled pen delivering doses of 0.25 mg or 0.5 mg Pre-filled pen delivering doses of 1 mg and Pre-filled pen delivering doses of 2 mg ATC code: A10BJ06 Antihyperglycemic Agent Glucagon-like Peptide-1 (GLP-1) Receptor Agonist Novo Nordisk Canada 101 – 2476 Argentia Road Mississauga, Ontario L5N 6M1 Date of Initial Authorization: January 4, 2018 Date of Revision: March 15, 2024 Submission Control No: 279986 _ _ _Product Monograph Ozempic_ _®_ _ _ _semaglutide injection _ _Page 2 of 62_ RECENT MAJOR LABEL CHANGES 4.2 Recommended Dose and Dosage Adjustment 01/2022 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 an Прочитать полный документ