TEVA-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
18-10-2021
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ingredients actius:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
N06AX23
Designació comuna internacional (DCI):
DESVENLAFAXINE
Dosis:
100MG
formulario farmacéutico:
TABLET (EXTENDED-RELEASE)
Composición:
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG
Vía de administración:
ORAL
Unidades en paquete:
30/100
tipo de receta:
Prescription
Resumen del producto:
Active ingredient group (AIG) number: 0152509002; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2022-02-14
Fitxa tècnica
PRODUCT MONOGRAPH
Pr
TEVA-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate)
Antidepressant
Teva Canada Limited
Date of Revision:
30 Novopharm Court
October 18, 2021
Toronto, Ontario
M1B 2K9
Control No.: 256177
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................
3
SUMMARY PRODUCT INFORMATION
................................................................................3
INDICATIONS AND CLINICAL USE
.....................................................................................3
CONTRAINDICATIONS
.........................................................................................................3
WARNINGS AND PRECAUTIONS
.........................................................................................4
ADVERSE
REACTIONS........................................................................................................
11
DRUG INTERACTIONS
........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
23
OVERDOSAGE
.....................................................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY.....................................................................
26
STORAGE AND STABILITY
................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING....................................................... 30
PART II: SCIENTIFIC INFORMATION
.............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
.......
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