LEFLUNOMIDE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
29-12-2016
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ingredients actius:
LEFLUNOMIDE
Disponible des:
SANIS HEALTH INC
Codi ATC:
L04AK01
Designació comuna internacional (DCI):
LEFLUNOMIDE
Dosis:
20MG
formulario farmacéutico:
TABLET
Composición:
LEFLUNOMIDE 20MG
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: 0140182002; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2014-07-11
Fitxa tècnica
PRODUCT MONOGRAPH
PR
LEFLUNOMIDE
(Leflunomide)
10 mg and 20 mg Tablets
Sanis Standard
Antirheumatic, Immunomodulator Agent
SANIS HEALTH INC.
Date of Revision:
1 Presidents Choice Circle
December 20, 2016
Brampton, Ontario
L6Y 5S5
Submission Control No.: 200318
2
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
.........................................................................................................
18
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 P
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