SEMGLEE SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

INSULIN GLARGINE

Доступна з:

BIOCON SDN.BHD

Код атс:

A10AE04

ІПН (Міжнародна Ім'я):

INSULIN GLARGINE

Дозування:

100UNIT

Фармацевтична форма:

SOLUTION

Склад:

INSULIN GLARGINE 100UNIT

Адміністрація маршрут:

SUBCUTANEOUS

Одиниць в упаковці:

15G/50G

Тип рецепту:

Schedule D

Огляд продуктів:

Active ingredient group (AIG) number: 0147062001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2022-04-08

Характеристики продукта

_Product Monograph _
_ _
_Semglee_
_®_
_Insulin Glargine Injection (rDNA Origin) _
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SEMGLEE®
Insulin Glargine Injection (rDNA Origin)
Solution for Subcutaneous Injection 100 units/mL
Antidiabetic Agent
ATC Code: A10AE04
Long-acting Recombinant Human Insulin Analogue
Manufactured by
BIOCON SDN. BHD.
No.1, Jalan Bioteknologi 1, Kawasan Perindustrian SiLC,
79200 Iskandar Puteri, Johor, Malaysia.
Distributed by
BGP PHARMA ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Initial Authorization:
April 08, 2022
Date of Revision:
May 11, 2023
Submission Control Number: 273654
_ _
_Product Monograph _
_ _
_Semglee_
_®_
_Insulin Glargine Injection (rDNA Origin) _
_Page 2 of 48_
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TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics (> 6 years of age)
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4
1.2
Geriatrics (> 65 years of age)
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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