PRO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
11-01-2023
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Aktiv bestanddel:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Tilgængelig fra:
PRO DOC LIMITEE
ATC-kode:
N06AX23
INN (International Name):
DESVENLAFAXINE
Dosering:
100MG
Lægemiddelform:
TABLET (EXTENDED-RELEASE)
Sammensætning:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG
Indgivelsesvej:
ORAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Produkt oversigt:
Active ingredient group (AIG) number: 0152509002; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2022-04-29
Produktets egenskaber
_PRO-DESVENLAFAXINE PRODUCT MONOGRAPH _
PAGE 1 OF 50
PRODUCT MONOGRAPH
PR
PRO-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate)
ANTIDEPRESSANT
DATE OF REVISION:
JAN 10, 2023
CONTROL NUMBER: 270605
PRO DOC LTÉE
2925 BOULEVARD INDUSTRIEL
LAVAL, QUEBEC
H7L 3W9
_PRO-DESVENLAFAXINE PRODUCT MONOGRAPH _
PAGE 2 OF 50
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
22
DOSAGE AND ADMINISTRATION
.....................................................................................
25
OVERDOSAGE
........................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
29
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
PHARMACEUTICAL INFORM
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