SEMGLEE SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

INSULIN GLARGINE

Доступно од:

BIOCON SDN.BHD

АТЦ код:

A10AE04

INN (Међународно име):

INSULIN GLARGINE

Дозирање:

100UNIT

Фармацеутски облик:

SOLUTION

Састав:

INSULIN GLARGINE 100UNIT

Пут администрације:

SUBCUTANEOUS

Јединице у пакету:

15G/50G

Тип рецептора:

Schedule D

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2022-04-08

Карактеристике производа

_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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