MAR-QUETIAPINE TABLET (IMMEDIATE RELEASE)

国: カナダ

言語: 英語

ソース: Health Canada

即購入

製品の特徴 製品の特徴 (SPC)
16-11-2022

有効成分:

QUETIAPINE (QUETIAPINE FUMARATE)

から入手可能:

MARCAN PHARMACEUTICALS INC

ATCコード:

N05AH04

INN(国際名):

QUETIAPINE

投薬量:

200MG

医薬品形態:

TABLET (IMMEDIATE RELEASE)

構図:

QUETIAPINE (QUETIAPINE FUMARATE) 200MG

投与経路:

ORAL

パッケージ内のユニット:

100/500

処方タイプ:

Prescription

治療領域:

ATYPICAL ANTIPSYCHOTICS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2013-01-16

製品の特徴

                                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
                                
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製品の特徴 製品の特徴 フランス語 16-11-2022

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