KIRSTY SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

INSULIN ASPART

제공처:

BIOCON SDN.BHD

ATC 코드:

A10AB05

INN (국제 이름):

INSULIN ASPART

복용량:

100UNIT

약제 형태:

SOLUTION

구성:

INSULIN ASPART 100UNIT

관리 경로:

SUBCUTANEOUS

패키지 단위:

100

처방전 유형:

Schedule D

치료 영역:

INSULINS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2023-05-11

제품 특성 요약

_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
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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
...................................................