DULOXETINE CAPSULE (DELAYED RELEASE)
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
06-02-2023
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有効成分:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
から入手可能:
ALTAMED PHARMA
ATCコード:
N06AX21
INN（国際名）:
DULOXETINE
投薬量:
60MG
医薬品形態:
CAPSULE (DELAYED RELEASE)
構図:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
投与経路:
ORAL
パッケージ内のユニット:
30/100/1000
処方タイプ:
Prescription
治療領域:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
製品概要:
Active ingredient group (AIG) number: 0152350002; AHFS:
認証ステータス:
APPROVED
承認日:
2023-02-06
製品の特徴
______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 1 of 82_
PRODUCT MONOGRAPH
PR DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Altamed Pharma
1565, boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
Submission Control No.: 271223
DATE OF REVISION:
FEB
06,
2023
______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 2 of 82_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT
INFORMATION......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
5
WARNINGS AND PRECAUTIONS
...............................................................................
6
ADVERSE REACTIONS
................................................................................................
18
DRUG INTERACTIONS
................................................................................................
37
DOSAGE AND ADMINISTRATION
............................................................................
40
OVERDOSAGE
..............................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 44
STORAGE AND STABILITY
........................................................................................
47
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 47
PART II: SCIENTIFIC INFORMATION
..............................................................................
49
PHARMACEUTICAL INFORMATION
..............................
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