TARO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
19-10-2022
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Aktiv bestanddel:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Tilgængelig fra:
TARO PHARMACEUTICALS INC
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:
2022-10-20
Produktets egenskaber
PRODUCT MONOGRAPH
PR TARO-DESVENLAFAXINE
desvenlafaxine extended-release tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate
monohydrate
)
Antidepressant
Taro Pharmaceuticals Inc.
Date of Revision:
130 East Drive
OCT 19, 2022
Brampton, Ontario
L6T 1C1
Submission Control No.: 264187
_________________________________________________________________________________________
_Taro-Desvenlafaxine (desvenlafaxine succinate monohydrate) Product
Monograph _
_Page 2 of 52_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFOR
M
ATION
.............................................................................
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
...........................................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................28
STORAGE AND STABILITY
....................................................................................................................31
SPECIAL HANDLING INSTRUCTIONS
.
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