VECTIBIX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PANITUMUMAB

Available from:

AMGEN CANADA INC

ATC code:

L01FE02

INN (International Name):

PANITUMUMAB

Dosage:

200MG

Pharmaceutical form:

SOLUTION

Composition:

PANITUMUMAB 200MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Schedule D

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2008-04-03

Summary of Product characteristics

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