DULOXETINE CAPSULE (DELAYED RELEASE)
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
06-02-2023
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Aktivní složka:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Dostupné s:
ALTAMED PHARMA
ATC kód:
N06AX21
INN (Mezinárodní Name):
DULOXETINE
Dávkování:
60MG
Léková forma:
CAPSULE (DELAYED RELEASE)
Složení:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Podání:
ORAL
Jednotky v balení:
30/100/1000
Druh předpisu:
Prescription
Terapeutické oblasti:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Přehled produktů:
Active ingredient group (AIG) number: 0152350002; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2023-02-06
Charakteristika produktu
______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 1 of 82_
PRODUCT MONOGRAPH
PR DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Altamed Pharma
1565, boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
Submission Control No.: 271223
DATE OF REVISION:
FEB
06,
2023
______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 2 of 82_
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
................................................................................................
18
DRUG INTERACTIONS
................................................................................................
37
DOSAGE AND ADMINISTRATION
............................................................................
40
OVERDOSAGE
..............................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 44
STORAGE AND STABILITY
........................................................................................
47
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 47
PART II: SCIENTIFIC INFORMATION
..............................................................................
49
PHARMACEUTICAL INFORMATION
..............................
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