NU-LEFLUNOMIDE TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
02-02-2012
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ingredients actius:
LEFLUNOMIDE
Disponible des:
NU-PHARM INC
Codi ATC:
L04AK01
Designació comuna internacional (DCI):
LEFLUNOMIDE
Dosis:
20MG
formulario farmacéutico:
TABLET
Composición:
LEFLUNOMIDE 20MG
Vía de administración:
ORAL
Unidades en paquete:
100
tipo de receta:
Prescription
Área terapéutica:
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Resumen del producto:
Active ingredient group (AIG) number: 0140182002; AHFS:
Estat d'Autorització:
CANCELLED (UNRETURNED ANNUAL)
Data d'autorització:
2018-03-28
Fitxa tècnica
Page 1 of 62
PRODUCT MONOGRAPH
Pr
NU-LEFLUNOMIDE
LEFLUNOMIDE TABLETS
HOUSE STANDARD
10 MG AND 20 MG
ANTIRHEUMATIC, IMMUNOMODULATOR AGENT
NU-PHARM INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT 2
FEBRUARY 2, 2012
VAUGHAN, ONTARIO
L4K 4N7
CONTROL #: 152701
Page 2 of 62
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
....................................................................................................................13
DRUG
INTERACTIONS.....................................................................................................................18
DOSAGE AND
ADMINISTRATION.................................................................................................21
OVERDOSAGE
...................................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................23
STORAGE AND
STABILITY.............................................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................26
PART II: SCIENTIFIC INFORMATION
...........................................................................................27
PHARMACEUTICAL
INFORMATION....................................................................................
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