KIRSTY SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

INSULIN ASPART

Beszerezhető a:

BIOCON SDN.BHD

ATC-kód:

A10AB05

INN (nemzetközi neve):

INSULIN ASPART

Adagolás:

100UNIT

Gyógyszerészeti forma:

SOLUTION

Összetétel:

INSULIN ASPART 100UNIT

Az alkalmazás módja:

SUBCUTANEOUS

db csomag:

100

Recept típusa:

Schedule D

Terápiás terület:

INSULINS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2023-05-11

Termékjellemzők

_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_ _
RECENT MAJOR LABEL CHANGES
[Section number and heading], [Subsection number and heading]
[MM/YYYY]
[Section number and heading], [Subsection number and heading]
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TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
.........................................................................................
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
...................................................