SEMGLEE SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

INSULIN GLARGINE

Dostupné s:

BIOCON SDN.BHD

ATC kód:

A10AE04

INN (Mezinárodní Name):

INSULIN GLARGINE

Dávkování:

100UNIT

Léková forma:

SOLUTION

Složení:

INSULIN GLARGINE 100UNIT

Podání:

SUBCUTANEOUS

Jednotky v balení:

15G/50G

Druh předpisu:

Schedule D

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2022-04-08

Charakteristika produktu

_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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PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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4
1.1
Pediatrics (> 6 years of age)
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1.2
Geriatrics (> 65 years of age)
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2
CONTRAINDICATIONS
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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