SEROQUEL XR TABLET (EXTENDED-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:

150MG

Forma farmaceutyczna:

TABLET (EXTENDED-RELEASE)

Skład:

QUETIAPINE (QUETIAPINE FUMARATE) 150MG

Droga podania:

ORAL

Sztuk w opakowaniu:

60

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131858004; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2009-01-09

Charakterystyka produktu

SEROQUEL
XR
®
Product Monograph. COPYRIGHT
2007-2021 ASTRAZENECA CANADA INC. Page 1 of 69
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SEROQUEL XR
®
quetiapine fumarate
Extended-Release Tablets, 50, 150, 200, 300 and 400 mg, Oral Use
Professed
Antipsychotic / Antidepressant Agent
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
SEP 27, 2007
Date of Revision:
JAN 04, 2022
Submission Control No: 255494
SEROQUEL XR
®
is a registered trademark of AstraZeneca UK Limited, used under
license by
AstraZeneca Canada Inc.
SEROQUEL
XR
®
Product Monograph. COPYRIGHT
2007-2021 ASTRAZENECA CANADA INC . Page 2 of 69
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 .
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1.
INDICATIONS..............................................................................................................
4
1.1
Pediatrics..........................................................................................................
4
1.2
Geriatrics
..........................................................................................................
4
2.
CONTRAINDICATIONS
...............................................................................................
5
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
.............