BEXXAR THERAPY SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

TOSITUMOMAB

Beschikbaar vanaf:

GLAXOSMITHKLINE INC

ATC-code:

V10XA53

INN (Algemene Internationale Benaming):

TOSITUMOMAB/IODINE (131 I) TOSITUMOMAB

Dosering:

14MG

farmaceutische vorm:

SOLUTION

Samenstelling:

TOSITUMOMAB 14MG

Toedieningsweg:

INTRAVENOUS

Eenheden in pakket:

35/225 MG VIAL

Prescription-type:

Schedule D

Therapeutisch gebied:

ANTINEOPLASTIC AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0151303001; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2014-07-31

Productkenmerken

_Webtop/1147/517/131-pm-non-Bexxar.doc _
_April 10, 2013 _
_ _
_Page 1 of 52_
PRODUCT MONOGRAPH
BEXXAR
® THERAPY
(tositumomab and iodine I 131 tositumomab)
Intravenous 35 mg and 225 mg tositumomab
444-666 MBq (12 -18 mCi) and 4144-6216 MBq (112 - 168 mCi) iodine I
131
tositumomab
Anti-Neoplastic Radioimmunotherapeutic
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Approval:
April 19, 2013
Submission Control No: 161826
_©_
_ 2013 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_BEXXAR used under license by GlaxoSmithKline Inc._
_Webtop/1147/517/131-pm-non-Bexxar.doc _
_April 10, 2013 _
_ _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................ 3
SUMMARY PRODUCT INFORMATION
........................................................... 3
DESCRIPTION.......................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................. 4
CONTRAINDICATIONS
......................................................................................
5
WARNINGS AND PRECAUTIONS
.....................................................................
5
ADVERSE REACTIONS
.......................................................................................
9
DRUG INTERACTIONS
.....................................................................................
16
DOSAGE AND ADMINISTRATION
................................................................. 16
OVERDOSAGE
...................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
............................................... 34
RADIATION DOSIMETRY
..............................................................................
36
STORAGE AND STABILITY
.............................................................................
36
SPECIAL HANDLING INSTRUCTIONS
..............................................