VECTIBIX SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PANITUMUMAB

Доступно од:

AMGEN CANADA INC

АТЦ код:

L01FE02

INN (Међународно име):

PANITUMUMAB

Дозирање:

400MG

Фармацеутски облик:

SOLUTION

Састав:

PANITUMUMAB 400MG

Пут администрације:

INTRAVENOUS

Јединице у пакету:

1

Тип рецептора:

Prescription

Терапеутска област:

ANTINEOPLASTIC AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0152457001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2008-04-03

Карактеристике производа

_ _
_ 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.................................................................................................