PHL-LEFLUNOMIDE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

LEFLUNOMIDE

Dostupno od:

PHARMEL INC

ATC koda:

L04AK01

INN (International ime):

LEFLUNOMIDE

Doziranje:

20MG

Farmaceutski oblik:

TABLET

Sastav:

LEFLUNOMIDE 20MG

Administracija rute:

ORAL

Jedinice u paketu:

30

Tip recepta:

Prescription

Područje terapije:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0140182002; AHFS:

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2008-10-31

Svojstava lijeka

PRODUCT MONOGRAPH
PR PHL-LEFLUNOMIDE
Leflunomide Tablets, House Standard
10 mg and 20 mg
Antirheumatic, Immunomodulator Agent
PHARMEL INC.
6111 Royalmount Avenue, Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
June 22, 2016
Submission Control No.: 195001
_phl-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
...................................................................