VECTIBIX SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PANITUMUMAB

Dostupné s:

AMGEN CANADA INC

ATC kód:

L01FE02

INN (Mezinárodní Name):

PANITUMUMAB

Dávkování:

200MG

Léková forma:

SOLUTION

Složení:

PANITUMUMAB 200MG

Podání:

INTRAVENOUS

Jednotky v balení:

100

Druh předpisu:

Schedule D

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2008-04-03

Charakteristika produktu

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