DULOXETINE CAPSULE (DELAYED RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

제공처:

SIVEM PHARMACEUTICALS ULC

ATC 코드:

N06AX21

INN (국제 이름):

DULOXETINE

복용량:

60MG

약제 형태:

CAPSULE (DELAYED RELEASE)

구성:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0152350002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2016-05-04

제품 특성 요약

______________________________________________________________________________
_DULOXETINE Product Monograph_
_ Page 1 of 83_
PRODUCT MONOGRAPH
PR DULOXETINE
Duloxetine Delayed-Release Capsules
30 mg and 60 mg duloxetine (as duloxetine hydrochloride)
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Submission Control No.: 273426
Date of
Initial Authorization:
MAY
4, 2016
Date of
Revision:
APR
13, 2023
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
______________________________________________________________________________
_DULOXETINE Product Monograph_
_ Page 2 of 83_
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
................................................................................................
19
DRUG INTERACTIONS
................................................................................................
39
DOSAGE AND ADMINISTRATION
............................................................................
42
OVERDOSAGE
..............................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 46
STORAGE AND STABILITY
........................................................................................
49
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 49
PART II: SCIENTIFIC INFORMATION
..................................................................