FUCIDIN H CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FUSIDIC ACID; HYDROCORTISONE ACETATE

Available from:

LEO PHARMA INC

ATC code:

D07CA01

INN (International Name):

HYDROCORTISONE AND ANTIBIOTICS

Dosage:

2%; 1%

Pharmaceutical form:

CREAM

Composition:

FUSIDIC ACID 2%; HYDROCORTISONE ACETATE 1%

Administration route:

TOPICAL

Units in package:

5/30G

Prescription type:

Prescription

Therapeutic area:

ANTIBIOTICS

Product summary:

Active ingredient group (AIG) number: 0234281001; AHFS:

Authorization status:

APPROVED

Authorization date:

1998-08-13

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FUCIDIN
® H
Fusidic acid and Hydrocortisone acetate
2% / 1% Cream
Topical Antibiotic / Corticosteroid
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.com/canada
Date of initial
approval:
AUG 18, 1998
Date of Revision:
JUNE 30, 2017
Submission Control No.: 202375
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
LEO®
_ _
_FUCIDIN® H (fusidic acid & hydrocortisone acetate) Product
Monograph, version 1.03 _
_ Page 2 of 23 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 3
1
INDICATIONS
........................................................................................................................
3
2
CONTRAINDICATIONS
........................................................................................................
3
3
DOSAGE AND ADMINISTRATION
......................................................................................
3
3.1
Dosing considerations
.................................................................................................
3
3.2
Administration
.............................................................................................................
3
4
OVERDOSAGE
.....................................................................................................................
4
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
.............................. 4
6
WARNINGS AND PRECAUTIONS
.......................................................................................
4
6.1
Special Populations
....................................................................................................
5
6.1.1
Pregnant Women
....................................................................................................
5
6.1.2
Breast-feeding
.........................................................................................................
6
6.1.3
Pediatrics
.......