DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
06-02-2023
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Aktiv bestanddel:
DESVENLAFAXINE
Tilgængelig fra:
SANIS HEALTH INC
ATC-kode:
N06AX23
INN (International Name):
DESVENLAFAXINE
Dosering:
50MG
Lægemiddelform:
TABLET (EXTENDED-RELEASE)
Sammensætning:
DESVENLAFAXINE 50MG
Indgivelsesvej:
ORAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Produkt oversigt:
Active ingredient group (AIG) number: 0152509001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2023-02-06
Produktets egenskaber
_ _
_DESVENLAFAXINE PRODUCT MONOGRAPH PAGE 1 OF 51 _
PRODUCT MONOGRAPH
PR
DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
Extended-release tablets, 50 mg and 100 mg Desvenlafaxine, Oral
Antidepressant
SANIS HEALTH INC.
1 PRESIDENT'S CHOICE CIRCLE
BRAMPTON, ONTARIO
L6Y 5S5
SUBMISSION CONTROL NUMBER: 270697
DATE OF
PREPARATION:
FEB
06, 2023
_ _
_DESVENLAFAXINE PRODUCT MONOGRAPH PAGE 2 OF 51 _
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
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
24
OVERDOSAGE
........................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
28
STORAGE AND STABILITY
.................................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
P
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