OZEMPIC SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SEMAGLUTIDE

Доступна з:

NOVO NORDISK CANADA INC

Код атс:

A10BJ06

ІПН (Міжнародна Ім'я):

SEMAGLUTIDE

Дозування:

1.34MG

Фармацевтична форма:

SOLUTION

Склад:

SEMAGLUTIDE 1.34MG

Адміністрація маршрут:

SUBCUTANEOUS

Одиниць в упаковці:

1X 2MG/PEN

Тип рецепту:

Prescription

Терапевтична области:

INCRETIN MIMETICS

Огляд продуктів:

Active ingredient group (AIG) number: 0159870002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-01-04

Характеристики продукта

_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