MINT-OLANZAPINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

OLANZAPINE

Disponible desde:

MINT PHARMACEUTICALS INC

Código ATC:

N05AH03

Designación común internacional (DCI):

OLANZAPINE

Dosis:

15MG

formulario farmacéutico:

TABLET

Composición:

OLANZAPINE 15MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ATYPICAL ANTIPSYCHOTICS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2013-09-04

Ficha técnica

PRODUCT MONOGRAPH
Pr
MINT-OLANZAPINE
Olanzapine Tablets
2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg
House Standard
Antipsychotic Agent
Mint Pharmaceuticals Inc.
Date of Revision:
1093 Meyerside Drive, Unit 1
13 June 2017
Mississauga, Ontario
L5T 1J6 SUBMISSION CONTROL NO: 206312
Page 2 of 63
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
..............................................................................................................
30
DOSAGE AND ADMINISTRATION
..........................................................................................
31
OVERDOSAGE
............................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
........................................................................
34
STORAGE AND STABILITY
......................................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 36
PART II: SCIENTIFIC INFORMATION
...................................................................................
38
PHARMACEUTICAL INFORMATION
......................................................................................
38
CLINICAL TRIALS
...............................