PMS-LEFLUNOMIDE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
02-02-2016
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Aktívna zložka:
LEFLUNOMIDE
Dostupné z:
PHARMASCIENCE INC
ATC kód:
L04AA13
INN (Medzinárodný Name):
LEFLUNOMIDE
Dávkovanie:
10MG
Forma lieku:
TABLET
Zloženie:
LEFLUNOMIDE 10MG
Spôsob podávania:
ORAL
Počet v balení:
30/100
Typ predpisu:
Prescription
Terapeutické oblasti:
DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
Prehľad produktov:
Active ingredient group (AIG) number: 0140182001; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2006-11-10
Súhrn charakteristických
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
....................................
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