VECTIBIX SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

PANITUMUMAB

Fáanlegur frá:

AMGEN CANADA INC

ATC númer:

L01FE02

INN (Alþjóðlegt nafn):

PANITUMUMAB

Skammtar:

100MG

Lyfjaform:

SOLUTION

Samsetning:

PANITUMUMAB 100MG

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

5ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2008-04-03

Vara einkenni

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