PMS-DULOXETINE CAPSULE (DELAYED RELEASE)
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
29-10-2021
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Werkstoffen:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Beschikbaar vanaf:
PHARMASCIENCE INC
ATC-code:
N06AX21
INN (Algemene Internationale Benaming):
DULOXETINE
Dosering:
30MG
farmaceutische vorm:
CAPSULE (DELAYED RELEASE)
Samenstelling:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0152350001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2016-05-02
Productkenmerken
PRODUCT MONOGRAPH
Pr
PMS-DULOXETINE
Duloxetine Delayed-Release Capsules, House Standard
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
October 29, 2021
SUBMISSION CONTROL NO: 253685
_ _
_pms-DULOXETINE Product Monograph _
_Page 2 of 84_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
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
.............................................48
PART II: SCIENTIFIC INFORMATION
................................................................................49
PHARMACEUTICAL INFORMATION
..........................................................................49
CLINICAL TRIALS
......................................................................................
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