PMS-LEFLUNOMIDE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

LEFLUNOMIDE

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

L04AA13

SNN (starptautisko nepatentēto nosaukumu):

LEFLUNOMIDE

Deva:

10MG

Zāļu forma:

TABLET

Kompozīcija:

LEFLUNOMIDE 10MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100

Receptes veids:

Prescription

Ārstniecības joma:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2006-11-10

Produkta apraksts

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
....................................