KIRSTY SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

INSULIN ASPART

から入手可能:

BIOCON SDN.BHD

ATCコード:

A10AB05

INN（国際名）:

INSULIN ASPART

投薬量:

100UNIT

医薬品形態:

SOLUTION

構図:

INSULIN ASPART 100UNIT

投与経路:

SUBCUTANEOUS

パッケージ内のユニット:

15G/50G

処方タイプ:

Schedule D

治療領域:

INSULINS

製品概要:

Active ingredient group (AIG) number: 0144802001; AHFS:

認証ステータス:

APPROVED

承認日:

2023-05-11

製品の特徴

_Kirsty Product Monograph _Page 1 of 61_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Kirsty
TM
Insulin Aspart Injection
100 Units / mL, Subcutaneous
Anti-diabetic Agent
ATC code: A10AB05
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, Ontario
M8Z 2S6
Date of Initial Authorization
October 12, 2021
Date of Revision
May 11, 2023
Submission Control No: 273553
_Kirsty Product Monograph _Page 2 of 61_ _
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TABLE OF CONTENTS
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2
TABLE OF CONTENTS
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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 and Dosage Adjustment
...................................................