TEVA-LEFLUNOMIDE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LEFLUNOMIDE

متاح من:

TEVA CANADA LIMITED

ATC رمز:

L04AK01

INN (الاسم الدولي):

LEFLUNOMIDE

جرعة:

10MG

الشكل الصيدلاني:

TABLET

تركيب:

LEFLUNOMIDE 10MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2004-12-10

خصائص المنتج

TEVA-LEFLUNOMIDE
Page 1 of 77
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR TEVA-LEFLUNOMIDE
Leflunomide Tablets
Film-coated tablets, 10 mg and 20 mg, Oral
Teva Standard
Antirheumatic, Immunomodulator Agent
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
December 10, 2004
Toronto, ON
M1B 2K9
Date of Revision:
Canada June 5, 2023
www.tevacanada.com
Submission Control Number: 270353
2
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics
.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 5
4.4
Administration
....................................................................................................
6
4.5
Missed Dose
........................................................................................................
6
5
OVERDOSAGE
..........................................................................................................
6
6
DOSAGE FORMS, S