KIRSTY SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

INSULIN ASPART

Saatavilla:

BIOCON SDN.BHD

ATC-koodi:

A10AB05

INN (Kansainvälinen yleisnimi):

INSULIN ASPART

Annos:

100UNIT

Lääkemuoto:

SOLUTION

Koostumus:

INSULIN ASPART 100UNIT

Antoreitti:

SUBCUTANEOUS

Kpl paketissa:

15G/50G

Prescription tyyppi:

Schedule D

Terapeuttinen alue:

INSULINS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-05-11

Valmisteyhteenveto

_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
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
...............................................................................................................
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
...................................................