BESPONSA POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

INOTUZUMAB OZOGAMICIN

Verfügbar ab:

PFIZER CANADA ULC

ATC-Code:

L01FB01

INN (Internationale Bezeichnung):

INOTUZUMAB OZOGAMICIN

Dosierung:

0.9MG

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

INOTUZUMAB OZOGAMICIN 0.9MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

ANTINEOPLASTIC AGENTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0160110001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2018-03-15

Fachinformation

_BESPONSA_
_TM_
_ Product Monograph _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BESPONSA
TM
inotuzumab ozogamicin for injection
Lyophilized powder for solution for infusion
0.9 mg single-dose vial
Anti-neoplastic Agent
Pfizer Canada Inc.
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Approval:
March 15, 2018
SUBMISSION CONTROL NO: 204077
TM
Pfizer Inc.
Pfizer Canada Inc., Licensee
_BESPONSA_
_TM_
_ Product Monograph _
_Page 2 of 43 _
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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 24
STORAGE AND STABILTY
..........................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
......................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
P