KIRSTY SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

INSULIN ASPART

Dostupné s:

BIOCON SDN.BHD

ATC kód:

A10AB05

INN (Mezinárodní Name):

INSULIN ASPART

Dávkování:

100UNIT

Léková forma:

SOLUTION

Složení:

INSULIN ASPART 100UNIT

Podání:

SUBCUTANEOUS

Jednotky v balení:

15G/50G

Druh předpisu:

Schedule D

Terapeutické oblasti:

INSULINS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2023-05-11

Charakteristika produktu

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