PMS-QUETIAPINE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

QUETIAPINE (QUETIAPINE FUMARATE)

Dostępny od:

PHARMASCIENCE INC

Kod ATC:

N05AH04

INN (International Nazwa):

QUETIAPINE

Dawkowanie:

100MG

Forma farmaceutyczna:

TABLET

Skład:

QUETIAPINE (QUETIAPINE FUMARATE) 100MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2008-09-04

Charakterystyka produktu

_pms-QUETIAPINE Product Monograph _
_Page 1 of 60_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PMS-QUETIAPINE
Quetiapine Tablets
Tablets, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg quetiapine
(as quetiapine fumarate), Oral
House Standard
Antipsychotic Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 260475
Date of Initial Authorization:
SEP 04, 2008
Date of Revision:
February 9, 2022
_pms-QUETIAPINE Product Monograph _
_Page 2 of 60_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal, Rhabdomyolysis
02/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
02/2022
7 WARNINGS AND PRECAUTIONS, Skin
12/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.....................................................................................
2
TABLE OF CONTENTS
..........................................................................................................
2
PART I : HEALTH PROFESSIONAL
INFORMATION..............................................................
4
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
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