VECTIBIX SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PANITUMUMAB

זמין מ:

AMGEN CANADA INC

קוד ATC:

L01FE02

INN (שם בינלאומי):

PANITUMUMAB

כמות:

200MG

טופס פרצבטיות:

SOLUTION

הרכב:

PANITUMUMAB 200MG

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

100

סוג מרשם:

Schedule D

איזור תרפויטי:

ANTINEOPLASTIC AGENTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2008-04-03

מאפייני מוצר

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