VECTIBIX SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PANITUMUMAB

Beschikbaar vanaf:

AMGEN CANADA INC

ATC-code:

L01FE02

INN (Algemene Internationale Benaming):

PANITUMUMAB

Dosering:

200MG

farmaceutische vorm:

SOLUTION

Samenstelling:

PANITUMUMAB 200MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

100

Prescription-type:

Schedule D

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2008-04-03

Productkenmerken

_ _
_VECTIBIX Product Monograph _
_Page 1 of 62_
PRODUCT MONOGRAPH
PR
VECTIBIX

(panitumumab)
Sterile Solution for Infusion
100, 400 mg (20 mg/mL)
Professed Standard
Antineoplastic
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, Ontario
L5N 0A4
Date of Preparation:
March 31, 2017
Submission Control No: 193962
© 2008-2017 Amgen Canada Inc., all rights reserved
_ _
_VECTIBIX Product Monograph _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
35
DOSAGE AND ADMINISTRATION
.............................................................................
35
OVERDOSAGE
...............................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 37
STORAGE AND STABILITY
.........................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
......................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 39
PART II: SCIENTIFIC INFORMATION
..........................