LEFLUNOMIDE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LEFLUNOMIDE

Tilgjengelig fra:

PRO DOC LIMITEE

ATC-kode:

L04AK01

INN (International Name):

LEFLUNOMIDE

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

LEFLUNOMIDE 10MG

Administreringsrute:

ORAL

Enheter i pakken:

30

Resept typen:

Prescription

Terapeutisk område:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2016-01-14

Preparatomtale

_ _
_Leflunomide (Leflunomide Tablets) _
_Page 1 of 79 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LEFLUNOMIDE
Leflunomide Tablets
Film-coated Tablets, 10 mg and 20 mg, Oral
BP
Antirheumatic, Immunomodulator Agent
ATC Code: L04AA13
Pro Doc Ltée
2925 boul. Industriel
Laval, Québec
H7L 3W9
Date of Initial Authorization:
NOV 26, 2013
Date of Revision:
JUL 11, 2023
Submission Control Number: 276418
_ _
_Leflunomide (Leflunomide Tablets) _
_Page 2 of 79 _
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
OVERDOSAGE
...................