DOM-LEFLUNOMIDE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

LEFLUNOMIDE

Commercializzato da:

DOMINION PHARMACAL

Codice ATC:

L04AA13

INN (Nome Internazionale):

LEFLUNOMIDE

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

LEFLUNOMIDE 10MG

Via di somministrazione:

ORAL

Confezione:

30

Tipo di ricetta:

Prescription

Area terapeutica:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2008-04-29

Scheda tecnica

PRODUCT MONOGRAPH
PR DOM-LEFLUNOMIDE
Leflunomide Tablets, House Standard
10 mg and 20 mg
Antirheumatic, Immunomodulator Agent
DOMINION PHARMACAL
6111 Royalmount Avenue, Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
June 15, 2016
Submission Control No.: 194974
_Dom-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
.............................................................