MAR-QUETIAPINE TABLET (IMMEDIATE RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

QUETIAPINE (QUETIAPINE FUMARATE)

Disponible desde:

MARCAN PHARMACEUTICALS INC

Código ATC:

N05AH04

Designación común internacional (DCI):

QUETIAPINE

Dosis:

100MG

formulario farmacéutico:

TABLET (IMMEDIATE RELEASE)

Composición:

QUETIAPINE (QUETIAPINE FUMARATE) 100MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

ATYPICAL ANTIPSYCHOTICS

Resumen del producto:

Active ingredient group (AIG) number: 0131858002; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2013-01-16

Ficha técnica

Page1 of58
PRODUCT MONOGRAPH
INCLUDING PATIENTMEDICATIONINFORMATION
Pr
MAR-QUETIAPINE
QuetiapineTablets
Immediate-ReleaseTablets,25, 100, 200 and300mg (asquetiapinefumarate),
OralUse
USP
AntipsychoticAgent
MarcanPharmaceuticals Inc.
2GurdwaraRoad,Suite#112
Ottawa,Ontario
K2E1A2 Canada
Date of InitialAuthorization:
JAN 16,2013
Date ofRevision:
NOV16,2022
SubmissionControl No.: 269102
Page2 of58
RECENT MAJORLABELCHANGES
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TABLE OF CONTENTS
Sectionsorsubsectionsthatare notapplicableat the time of authorization
are notlisted
1.
INDICATIONS
......................................................................................................................4
1.1
Pediatrics...............................................................................................................
4
1.2
Geriatrics
...............................................................................................................
4
2.
CONTRAINDICATIONS
.......................................................................................................4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................... 5
4.
DOSAGE AND ADMINISTRATION
.....................................................................................5
4.1
Dosing
Considerations...................................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..........................................................5
4.4
Administration........................................................................................................
7
4.5
Missed
Dose...................................................................................................................
7
5.
OVERDOSAGE
........................................................................................................................
7
6.
DOSA