ABBOTT-OLANZAPINE ODT TABLET (ORALLY DISINTEGRATING)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

OLANZAPINE

Disponible des:

ABBOTT LABORATORIES, LIMITED

Codi ATC:

N05AH03

Designació comuna internacional (DCI):

OLANZAPINE

Dosis:

10MG

formulario farmacéutico:

TABLET (ORALLY DISINTEGRATING)

Composición:

OLANZAPINE 10MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ATYPICAL ANTIPSYCHOTICS

Resumen del producto:

Active ingredient group (AIG) number: 0128783002; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2015-12-31

Fitxa tècnica

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