KIRSTY SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INSULIN ASPART

Available from:

BIOCON SDN.BHD

ATC code:

A10AB05

INN (International Name):

INSULIN ASPART

Dosage:

100UNIT

Pharmaceutical form:

SOLUTION

Composition:

INSULIN ASPART 100UNIT

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Schedule D

Therapeutic area:

INSULINS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-05-11

Summary of Product characteristics

_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
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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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
...................................................