PMS-DULOXETINE CAPSULE (DELAYED RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
29-10-2021
Nogle dokumenter til dette produkt er ikke tilgængelige i øjeblikket, du kan sende en anmodning til vores kundeservice, og vi vil underrette dig, så snart vi er i stand til at få dem.
Send anmodning.
Send anmodning.
Aktiv bestanddel:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
N06AX21
INN (International Name):
DULOXETINE
Dosering:
60MG
Lægemiddelform:
CAPSULE (DELAYED RELEASE)
Sammensætning:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0152350002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2016-05-02
Produktets egenskaber
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
......................................................................................
Læs hele dokumentet
