Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
ENFORTUMAB VEDOTIN
SEAGEN INC.
L01FX13
ENFORTUMAB VEDOTIN
30MG
POWDER FOR SOLUTION
ENFORTUMAB VEDOTIN 30MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0163254002; AHFS:
APPROVED
2021-10-29
_PADCEV_ _®_ _ (enfortumab vedotin) _ _Page 1 of 34_ 27 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr PADCEV® enfortumab vedotin for injection lyophilized powder for solution for intravenous infusion only 20 mg and 30 mg single-use vials Antineoplastic Agent Seagen Inc. 21823 30 th Drive S.E. Bothell, WA 98021 Canadian importer: Seagen Canada Inc. 2000 Argentia Road, Plaza 3, Suite #400 Mississauga, ON L5N 1V9 Date of Initial Authorization: October 29, 2021 Date of Revision: July 7, 2023 Submission Control Number: 272213 PADCEV is a registered trademark of Seagen Inc., used under license ©Copyright 2021, Seagen Inc. _PADCEV_ _®_ _ (enfortumab vedotin) _ _Page 2 of 34_ RECENT MAJOR LABEL CHANGES 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment MM/YYYY 7 Warnings and Precautions MM/YYYY TABLE OF CONTENTS 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 ................................................................................... Izlasiet visu dokumentu