PMS-LEFLUNOMIDE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

LEFLUNOMIDE

Disponible desde:

PHARMASCIENCE INC

Código ATC:

L04AA13

Designación común internacional (DCI):

LEFLUNOMIDE

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

LEFLUNOMIDE 10MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

tipo de receta:

Prescription

Área terapéutica:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0140182001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2006-11-10

Ficha técnica

PRODUCT MONOGRAPH
PR PMS-LEFLUNOMIDE
Leflunomide Tablets, House Standard
10 mg and 20 mg
Antirheumatic, Immunomodulator Agent
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
January 27, 2016
Submission Control No.: 190194
_pms-LEFLUNOMIDE Product Monograph _
_Page 2 of 69_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...............................................................3
INDICATIONS AND CLINICAL USE
.....................................................................3
CONTRAINDICATIONS
..........................................................................................3
WARNINGS AND PRECAUTIONS
.........................................................................5
ADVERSE REACTIONS
.........................................................................................14
DRUG INTERACTIONS
.........................................................................................19
DOSAGE AND ADMINISTRATION
.....................................................................23
OVERDOSAGE
.......................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
...................................................25
STORAGE AND STABILITY
.................................................................................27
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................28
PART II: SCIENTIFIC INFORMATION
................................................................................29
PHARMACEUTICAL INFORMATION
.................................................................29
CLINICAL TRIALS
.................................................................................................30
DETAILED PHARMACOLOGY
............................................................................38
TOXICOLOGY
....................................