ABBOTT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

OLANZAPINE

Tilgjengelig fra:

ABBOTT LABORATORIES

ATC-kode:

N05AH03

INN (International Name):

OLANZAPINE

Dosering :

15MG

Legemiddelform:

TABLET (ORALLY DISINTEGRATING)

Sammensetning:

OLANZAPINE 15MG

Administreringsrute:

ORAL

Enheter i pakken:

30

Resept typen:

Prescription

Terapeutisk område:

ATYPICAL ANTIPSYCHOTICS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2015-12-31

Preparatomtale

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