Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
OXODOTREOTIDE
NOVARTIS PHARMACEUTICALS CANADA INC
V09I
TUMOUR DETECTION
40MCG
KIT
OXODOTREOTIDE 40MCG
INTRAVENOUS
15G/50G
Schedule C
ROENTGENOGRAPHY
Active ingredient group (AIG) number: 0161570001; AHFS:
APPROVED
2019-07-03
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NETSPOT® 40 microgram kit for the preparation of gallium ( 68 Ga) oxodotreotide for injection Diagnostic Radiopharmaceutical Kit Novartis Pharmaceuticals Canada Inc. 700 Saint-Hubert St., Suite 100 Montreal, Quebec H2Y 0C1 Date of Initial Authorization: Jul 03, 2019 Date of Revision: Feb 28, 2024 Submission Control Number: 282568 NETSPOT is a registered trademark _NETSPOT® (kit for the preparation of gallium (_ _68_ _Ga) oxodotreotide injection) _ _Page 2 of 28_ RECENT MAJOR LABEL CHANGES 4 Dosage and Administration, 4.4 Administration 06/2021 4 Dosage and Administration, 4.7 Instructions for Preparation and Use 06/2021 4 Dosage and Administration, 4.8 Radiation Dosimetry 06/2021 7 Warnings and Precautions 06/2021 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 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................................ 4 4 DOSAGE AND ADMINISTRATION ............................................................................................. 4 4.1 Dosing Considerations ........................................................... Soma hati kamili