NETVISION SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

GALLIUM 68 Ga OXODOTREOTIDE

Предлага се от:

UNIVERSITY HEALTH NETWORK

АТС код:

V09IX

INN (Международно Name):

OTHER DIAGNOSTIC RADIOPHARM. FOR TUMOR DETECTION

дозиране:

122MBq

Лекарствена форма:

SOLUTION

Композиция:

GALLIUM 68 Ga OXODOTREOTIDE 122MBq

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

15G/50G

Вид предписание :

Schedule C

Каталог на резюме:

Active ingredient group (AIG) number: 0163402001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-03-21

Данни за продукта

_NETVISION_
™
_ _
_(gallium (_
_68_
_Ga) oxodotreotide injection) _
_Product Monograph _
_Page 1 of 24_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
NETVISION™
GALLIUM (
68
GA) OXODOTREOTIDE INJECTION
Sterile Solution for intravenous injection
≤ 122 MBq/mL at End of Synthesis
Diagnostic Radiopharmaceutical
University Health Network (UHN)
UHN Radiotheranostics Core (UHNRC)
Toronto General Hospital
200 Elizabeth St., Suite B-PMB-174A
Canada
www.uhnrc.ca
Date of Initial Authorization:
February 24, 2022
Date of Revision:
March 21, 2023
Submission Control Number: 271932
_ _
_NETVISION_
™
_ (gallium (_
_68_
_Ga) oxodotreotide injection) Product Monograph _
_Page 2 of 24 _
RECENT MAJOR LABEL CHANGES
Not applicable.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
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 ............................................... 4
4
DOSAGE AND ADMINISTRATION .........................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....