MAR-QUETIAPINE TABLET (IMMEDIATE RELEASE)

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

QUETIAPINE (QUETIAPINE FUMARATE)

Доступно од:

MARCAN PHARMACEUTICALS INC

АТЦ код:

N05AH04

INN (Међународно име):

QUETIAPINE

Дозирање:

200MG

Фармацеутски облик:

TABLET (IMMEDIATE RELEASE)

Састав:

QUETIAPINE (QUETIAPINE FUMARATE) 200MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

ATYPICAL ANTIPSYCHOTICS

Резиме производа:

Active ingredient group (AIG) number: 0131858003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2013-01-16

Карактеристике производа

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
7 WARNINGS ANDPRECAUTIONS- Musculoskeletal- Rhabdomyolysis
11/2022
7 WARNINGS ANDPRECAUTIONS – Psychiatric
11/2022
7 WARNINGS ANDPRECAUTIONS - Skin
11/2022
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