ARAVA TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LEFLUNOMIDE

Tersedia dari:

SANOFI-AVENTIS CANADA INC

Kode ATC:

L04AK01

INN (Nama Internasional):

LEFLUNOMIDE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

LEFLUNOMIDE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

30

Jenis Resep:

Prescription

Area terapi:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2006-06-16

Karakteristik produk

_ _
_ARAVA (Leflunomide) _
_Page 1 of 75_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ARAVA®
Leflunomide
Film-coated Tablets 10, 20, 100 mg
Antirheumatic, Immunomodulator Agent
ATC Code: L04AA13
sanofi-aventis Canada Inc.
2905, Place Louis-R.-Renaud
Laval, Québec H7V 0A3
Date of Initial Authorization:
MAY 16, 2008
Date of Revision:
OCT 11, 2022
Submission Control Number: 264125
_ _
_ARAVA (Leflunomide) _
_Page 2 of 75_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
10/2022
TABLE OF CONTENTS
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, STRENGTHS, COMPOSITION AND PACKAGING
..........................