NETVISION SOLUTION

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

GALLIUM 68 Ga OXODOTREOTIDE

Fáanlegur frá:

UNIVERSITY HEALTH NETWORK

ATC númer:

V09IX

INN (Alþjóðlegt nafn):

OTHER DIAGNOSTIC RADIOPHARM. FOR TUMOR DETECTION

Skammtar:

122MBq

Lyfjaform:

SOLUTION

Samsetning:

GALLIUM 68 Ga OXODOTREOTIDE 122MBq

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Schedule C

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2023-03-21

Vara einkenni

_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
....