ABBOTT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

OLANZAPINE

MAH:

ABBOTT LABORATORIES

ATC_code:

N05AH03

INN:

OLANZAPINE

dosage:

15MG

pharmaceutical_form:

TABLET (ORALLY DISINTEGRATING)

composition:

OLANZAPINE 15MG

administration_route:

ORAL

units_in_package:

30

prescription_type:

Prescription

therapeutic_area:

ATYPICAL ANTIPSYCHOTICS

leaflet_short:

Active ingredient group (AIG) number: 0128783005; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2015-12-31

SPC

_ _
_Abbott-Olanzapine ODT Product Monograph _
_Page 1 of 62 _
PRODUCT MONOGRAPH
PR
ABBOTT-OLANZAPINE ODT
Olanzapine Orally Disintegrating Tablets
5 mg, 10 mg, 15 mg, 20 mg
Antipsychotic Agent
BGP Pharma Inc.
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
January 6, 2015
Submission Control No.: 180719
_ _
_Abbott-Olanzapine ODT Product Monograph _
_Page 2 of 62 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................27
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................31
ACTION AND CLINICAL PHARMACOLOGY
............................................................31
STORAGE AND STABILITY
..........................................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................35
PHARMACEUTICAL INFORMATION
..........................................................................35
CLINICAL TRIALS
............................................................................................