LUTATHERA SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LUTETIUM (177LU) OXODOTREOTIDE

Tilgjengelig fra:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC-kode:

V10XX04

INN (International Name):

LUTETIUM (177Lu) OXODOTREOTIDE

Dosering :

370MBq

Legemiddelform:

SOLUTION

Sammensetning:

LUTETIUM (177LU) OXODOTREOTIDE 370MBq

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

15G/50G

Resept typen:

Schedule C

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0161130001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2019-01-09

Preparatomtale

_LUTATHERA_
_®_
_ (lutetium (_
_177_
_Lu) oxodotreotide injection)_
_ _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
LUTATHERA®
lutetium (
177
Lu) oxodotreotide injection
Sterile Solution for Intravenous Infusion
370 MBq/mL at calibration
Therapeutic Radiopharmaceutical
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., Suite 100
Montreal, Quebec
H2Y 0C1
Date of Initial Authorization:
Jan 09, 2019
Date of Revision:
Feb 28, 2024
Submission Control Number: 282564
LUTATHERA is a registered trademark
_ _
_LUTATHERA_
_®_
_ (lutetium (_
_177_
_Lu) oxodotreotide injection) _
_ _
_ _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
05/2021
4 Dosage and Administration, 4.4 Administration
05/2021
7 Warnings and Precautions, Amino Acid Solution related Risks,
Hepatic/Biliary/Pancreatic, Renal
05/2021
7 Warnings and Precautions, Sensitivity/Resistance
07/2022
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 WARNIN