GD-MIRTAZAPINE OD TABLET (ORALLY DISINTEGRATING)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

MIRTAZAPINE

Disponible desde:

GENMED A DIVISION OF PFIZER CANADA ULC

Código ATC:

N06AX11

Designación común internacional (DCI):

MIRTAZAPINE

Dosis:

30MG

formulario farmacéutico:

TABLET (ORALLY DISINTEGRATING)

Composición:

MIRTAZAPINE 30MG

Vía de administración:

ORAL

Unidades en paquete:

5X6

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTIDEPRESSANTS

Resumen del producto:

Active ingredient group (AIG) number: 0143928002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2014-12-08

Ficha técnica

_GD-mirtazapine OD (mirtazapine) Product Monograph _
_Page 1 of 37_
PRODUCT MONOGRAPH
PR
GD-MIRTAZAPINE OD*
(Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg and 45 mg)
Antidepressant
GenMed, a division of Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
*GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
© Pfizer Canada Inc., 2012
Submission control No.: 153710 Date of Revision:
March 29, 2012
_GD-mirtazapine OD (mirtazapine) Product Monograph _
_Page 2 of 37_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL
USE....................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND
PRECAUTIONS........................................................................................
4
ADVERSE
REACTIONS..........................................................................................................
9
DRUG INTERACTIONS
........................................................................................................
14
DOSAGE AND ADMINISTRATION
....................................................................................
17
OVERDOSAGE
......................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 20
STORAGE AND
STABILITY................................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................