DULOXETINE CAPSULE (DELAYED RELEASE)
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
06-02-2023
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Verzend verzoek.
Werkstoffen:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Beschikbaar vanaf:
ALTAMED PHARMA
ATC-code:
N06AX21
INN (Algemene Internationale Benaming):
DULOXETINE
Dosering:
60MG
farmaceutische vorm:
CAPSULE (DELAYED RELEASE)
Samenstelling:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100/1000
Prescription-type:
Prescription
Therapeutisch gebied:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Product samenvatting:
Active ingredient group (AIG) number: 0152350002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2023-02-06
Productkenmerken
______________________________________________________________________________
_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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