SEROQUEL TABLET (IMMEDIATE RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

QUETIAPINE (QUETIAPINE FUMARATE)

Dostępny od:

ASTRAZENECA CANADA INC

Kod ATC:

N05AH04

INN (International Nazwa):

QUETIAPINE

Dawkowanie:

300MG

Forma farmaceutyczna:

TABLET (IMMEDIATE RELEASE)

Skład:

QUETIAPINE (QUETIAPINE FUMARATE) 300MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131858005; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2001-06-22

Charakterystyka produktu

SEROQUEL
®
Product Monograph. _ COPYRIGHT 1997-2021,_ ASTRAZENECA
CANADA INC. Page 1 of 56
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SEROQUEL
®
quetiapine fumarate
Immediate-Release Tablets, 25, 100, 200 and 300 mg, Oral Use
Professed
Antipsychotic Agent
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
DEC 2, 1997
Date of Revision:
NOV 29, 2021
Submission Control No: 254368
SEROQUEL
®
is a registered trademark of AstraZeneca UK Limited, used under
license by
AstraZeneca Canada Inc.
SEROQUEL
®
Product Monograph. _COPYRIGHT 1997-2021_, ASTRAZENECA CANA DA INC.
Page 2 of 56
RECENT MAJOR LABEL CHANGES
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04/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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......................