PMS-LEFLUNOMIDE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

LEFLUNOMIDE

Доступна з:

PHARMASCIENCE INC

Код атс:

L04AA13

ІПН (Міжнародна Ім'я):

LEFLUNOMIDE

Дозування:

10MG

Фармацевтична форма:

TABLET

Склад:

LEFLUNOMIDE 10MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100

Тип рецепту:

Prescription

Терапевтична области:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2006-11-10

Характеристики 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
....................................