PMS-DULOXETINE CAPSULE (DELAYED RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

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Prekės savybės Prekės savybės (SPC)
29-10-2021

Veiklioji medžiaga:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Prieinama:

PHARMASCIENCE INC

ATC kodas:

N06AX21

INN (Tarptautinis Pavadinimas):

DULOXETINE

Dozė:

30MG

Vaisto forma:

CAPSULE (DELAYED RELEASE)

Sudėtis:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100

Recepto tipas:

Prescription

Gydymo sritis:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkto santrauka:

Active ingredient group (AIG) number: 0152350001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2016-05-02

Prekės savybės

                                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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