TARO-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
19-10-2022
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ingredients actius:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Disponible des:
TARO PHARMACEUTICALS INC
Codi ATC:
N06AX23
Designació comuna internacional (DCI):
DESVENLAFAXINE
Dosis:
50MG
formulario farmacéutico:
TABLET (EXTENDED-RELEASE)
Composición:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG
Vía de administración:
ORAL
Unidades en paquete:
15G/50G
tipo de receta:
Prescription
Resumen del producto:
Active ingredient group (AIG) number: 0152509001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2022-10-20
Fitxa tècnica
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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