APO-LEFLUNOMIDE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

LEFLUNOMIDE

Disponível em:

APOTEX INC

Código ATC:

L04AK01

DCI (Denominação Comum Internacional):

LEFLUNOMIDE

Dosagem:

20MG

Forma farmacêutica:

TABLET

Composição:

LEFLUNOMIDE 20MG

Via de administração:

ORAL

Unidades em pacote:

30

Tipo de prescrição:

Prescription

Área terapêutica:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

2004-09-08

Características técnicas

_APO-LEFLUNOMIDE (Leflunomide Tablets) _
_ _
_ Page 1 of 73 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LEFLUNOMIDE
Leflunomide Tablets
Tablets, 10 mg and 20 mg, Oral
Apotex Standard
Antirheumatic, Immunomodulator Agent
ATC Code: L04AA13
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
September 8, 2004
Date of Revision:
July 24, 2023
Submission Control Number: 272007
_APO-LEFLUNOMIDE (Leflunomide Tablets) _
_ _
_Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2023
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