PMS-LEFLUNOMIDE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

LEFLUNOMIDE

Предлага се от:

PHARMASCIENCE INC

АТС код:

L04AA13

INN (Международно Name):

LEFLUNOMIDE

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

LEFLUNOMIDE 10MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100

Вид предписание :

Prescription

Терапевтична област:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2006-11-10

Данни за продукта

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