LEFLUNOMIDE TABLET

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LEFLUNOMIDE

Disponibbli minn:

PRO DOC LIMITEE

Kodiċi ATC:

L04AK01

INN (Isem Internazzjonali):

LEFLUNOMIDE

Dożaġġ:

20MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

LEFLUNOMIDE 20MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2016-01-14

Karatteristiċi tal-prodott

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_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
...................