NETSPOT KIT

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

OXODOTREOTIDE

Διαθέσιμο από:

NOVARTIS PHARMACEUTICALS CANADA INC

Φαρμακολογική κατηγορία (ATC):

V09I

INN (Διεθνής Όνομα):

TUMOUR DETECTION

Δοσολογία:

40MCG

Φαρμακοτεχνική μορφή:

KIT

Σύνθεση:

OXODOTREOTIDE 40MCG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Schedule C

Θεραπευτική περιοχή:

ROENTGENOGRAPHY

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0161570001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-07-03

Αρχείο Π.Χ.Π.

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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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1.2
Geriatrics
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
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