FUCIDIN OINTMENT 2%

Country: Կանադա

language: անգլերեն

source: Health Canada

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12-07-2017

active_ingredient:

FUSIDATE SODIUM

MAH:

LEO PHARMA INC

ATC_code:

D06AX01

INN:

FUSIDIC ACID

dosage:

2%

pharmaceutical_form:

OINTMENT

composition:

FUSIDATE SODIUM 2%

administration_route:

TOPICAL

units_in_package:

5G/30G

prescription_type:

Prescription

therapeutic_area:

ANTIBIOTICS

leaflet_short:

Active ingredient group (AIG) number: 0114229001; AHFS:

authorization_status:

MARKETED

authorization_date:

1984-12-31

SPC

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FUCIDIN
®
Fusidic acid
2% Cream
Sodium fusidate
2% Ointment
Antibiotic
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.com/canada
Date of initial
approval:
Aug 9, 1985
Date of Revision:
July 10, 2017
Submission Control No.: 202631
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
LEO®
_ _
_FUCIDIN® (fusidic acid/sodium fusidate) Product Monograph, version
1.04_
_ _
_Page 2 of 24_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
1
INDICATIONS
........................................................................................................................
3
2
CONTRAINDICATIONS
........................................................................................................
3
3
DOSAGE AND ADMINISTRATION
......................................................................................
3
3.1
Administration
.............................................................................................................
3
4
OVERDOSAGE
.....................................................................................................................
4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.............................. 4
6
WARNINGS AND PRECAUTIONS
.......................................................................................
5
6.1
Special Populations
....................................................................................................
5
6.1.1
Pregnant Women
....................................................................................................
5
6.1.2
Breast-feeding
.........................................................................................................
6
7
ADVERSE REACTIONS
.......................................................................................................
6
7.1
Adverse Reaction Overview
....................................
                                
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SPC SPC ֆրանսերեն 10-07-2017