TEVA-LACOSAMIDE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
01-08-2018
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ingredients actius:
LACOSAMIDE
Disponible des:
TEVA CANADA LIMITED
Codi ATC:
N03AX18
Designació comuna internacional (DCI):
LACOSAMIDE
Dosis:
50MG
formulario farmacéutico:
TABLET
Composición:
LACOSAMIDE 50MG
Vía de administración:
ORAL
Unidades en paquete:
60
tipo de receta:
Prescription
Área terapéutica:
MISCELLANEOUS ANTICONVULSANTS
Resumen del producto:
Active ingredient group (AIG) number: 0152810001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2018-10-01
Fitxa tècnica
_Teva-Lacosamide _
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PRODUCT MONOGRAPH
Pr
TEVA-LACOSAMIDE
lacosamide
50 mg, 100 mg, 150 mg, and 200 mg film-coated tablets
Antiepileptic Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
August 01, 2018
Submission Control No: 217490
_ _
_Teva-Lacosamide _
_Page 2 of 37_
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
................................................................................27
PHARMACEUTICAL INFORMATION
..........................................................................27
CLINICAL TRIALS
..........................................................................................................28
DETAILED PHARMACOLOGY
................................
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