Држава: Канада
Језик: Енглески
Извор: Health Canada
PANITUMUMAB
AMGEN CANADA INC
L01FE02
PANITUMUMAB
100MG
SOLUTION
PANITUMUMAB 100MG
INTRAVENOUS
5ML
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0152457001; AHFS:
APPROVED
2008-04-03
_ _ _ Vectibix_ _®_ _ (panitumumab) _ _Page 1 of 66_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR VECTIBIX panitumumab for injection Sterile Solution 100 mg, 400 mg (20 mg / mL) Professed Standard Antineoplastic Agent Amgen Canada Inc. 6775 Financial Drive, Suite 100 Mississauga, Ontario L5N 0A4 Date of Initial Authorization: April 3, 2008 Date of Revision: October 25, 2021 Submission Control Number: 253805 © 2008-2021 Amgen Canada Inc., all rights reserved _ _ _ Vectibix_ _®_ _ (panitumumab) _ _Page 2 of 66_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations XX/2021 7 WARNINGS AND PRECAUTIONS, Ophthalmologic XX/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION MAY NOT BE LISTED. 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...................................................... 5 4 DOSAGE AND ADMINISTRATION .............................................................................. 5 4.1 Dosing Considerations ........................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment .................................................... 6 4.3 Reconstitution..................................................................................................... 6 4.4 Administration................................................................................................. Прочитајте комплетан документ