MAR-QUETIAPINE TABLET (IMMEDIATE RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
16-11-2022
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Aktiv bestanddel:
QUETIAPINE (QUETIAPINE FUMARATE)
Tilgængelig fra:
MARCAN PHARMACEUTICALS INC
ATC-kode:
N05AH04
INN (International Name):
QUETIAPINE
Dosering:
25MG
Lægemiddelform:
TABLET (IMMEDIATE RELEASE)
Sammensætning:
QUETIAPINE (QUETIAPINE FUMARATE) 25MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100/500
Recept type:
Prescription
Terapeutisk område:
ATYPICAL ANTIPSYCHOTICS
Produkt oversigt:
Active ingredient group (AIG) number: 0131858001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2013-01-16
Produktets egenskaber
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
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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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