MAR-QUETIAPINE TABLET (IMMEDIATE RELEASE)
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
16-11-2022
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유효 성분:
QUETIAPINE (QUETIAPINE FUMARATE)
제공처:
MARCAN PHARMACEUTICALS INC
ATC 코드:
N05AH04
INN (International Name):
QUETIAPINE
복용량:
25MG
약제 형태:
TABLET (IMMEDIATE RELEASE)
구성:
QUETIAPINE (QUETIAPINE FUMARATE) 25MG
관리 경로:
ORAL
패키지 단위:
100/500
처방전 유형:
Prescription
치료 영역:
ATYPICAL ANTIPSYCHOTICS
제품 요약:
Active ingredient group (AIG) number: 0131858001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2013-01-16
제품 특성 요약
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
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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
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