PMS-DULOXETINE CAPSULE (DELAYED RELEASE)
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
29-10-2021
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Aktívna zložka:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Dostupné z:
PHARMASCIENCE INC
ATC kód:
N06AX21
INN (Medzinárodný Name):
DULOXETINE
Dávkovanie:
60MG
Forma lieku:
CAPSULE (DELAYED RELEASE)
Zloženie:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Spôsob podávania:
ORAL
Počet v balení:
30/100
Typ predpisu:
Prescription
Terapeutické oblasti:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Prehľad produktov:
Active ingredient group (AIG) number: 0152350002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2016-05-02
Súhrn charakteristických
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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