TEVA-LAMOTRIGINE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LAMOTRIGINE

Disponible desde:

TEVA CANADA LIMITED

Código ATC:

N03AX09

Designación común internacional (DCI):

LAMOTRIGINE

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

LAMOTRIGINE 100MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANTICONVULSANTS

Resumen del producto:

Active ingredient group (AIG) number: 0127134001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2010-11-12

Ficha técnica

PRODUCT MONOGRAPH
PR
TEVA-LAMOTRIGINE
(lamotri
g
ine)
25 mg, 100 mg and 150 mg
Tablets
Antiepileptic
USP
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
Nov 6, 2020
Submission Control No:
245553
TEVA-LAMOTRIGINE Product Monograph Page 2 of 49
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
........................................................................................................
13
DRUG
INTERACTIONS
........................................................................................................
20
DOSAGE
AND
ADMINISTRATION
....................................................................................
26
OVERDOSAGE
......................................................................................................................
30
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................... 30
STORAGE
AND
STABILITY
................................................................................................
34
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .................................................... 34
PART II: SCIENTIFIC INFORMATION
............................................................................
36
PHARMACEUTICAL
INFORMATION
................................................................................
36
CLINICAL
TRIALS
.....................................................................................................