KIRSTY SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

INSULIN ASPART

Dostopno od:

BIOCON SDN.BHD

Koda artikla:

A10AB05

INN (mednarodno ime):

INSULIN ASPART

Odmerek:

100UNIT

Farmacevtska oblika:

SOLUTION

Sestava:

INSULIN ASPART 100UNIT

Pot uporabe:

SUBCUTANEOUS

Enote v paketu:

100

Tip zastaranja:

Schedule D

Terapevtsko območje:

INSULINS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2023-05-11

Lastnosti izdelka

_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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[Section number and heading], [Subsection number and heading]
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TABLE OF CONTENTS
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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
...................................................