SANDOZ DULOXETINE CAPSULE (DELAYED RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
03-06-2022
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Aktiv bestanddel:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Tilgængelig fra:
SANDOZ CANADA INCORPORATED
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
______________________________________________________________________________
_Sandoz Duloxetine Product Monograph_
_ Page 1 of 84_
PRODUCT MONOGRAPH
PR SANDOZ DULOXETINE
Duloxetine Delayed-Release Capsules
30 mg and 60 mg duloxetine (as duloxetine hydrochloride)
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville,
Quebec
J4B 1E6
Submission
Control No: 259736 DATE OF REVISION: June 3, 2022
______________________________________________________________________________
_Sandoz 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
................................................................................................
5
WARNINGS AND PRECAUTIONS
...............................................................................
6
ADVERSE REACTIONS
................................................................................................
19
DRUG INTERACTIONS
................................................................................................
39
DOSAGE AND ADMINISTRATION
............................................................................
42
OVERDOSAGE
..............................................................................................................
45
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 46
STORAGE AND STABILITY
........................................................................................
49
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 49
PART II: SCIENTIFIC INFORMATION
..............................................................................
51
PHARMACEUTICAL INFORMATION
..........
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