FUCIBET CREAM

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FUSIDIC ACID; BETAMETHASONE (BETAMETHASONE VALERATE)

Available from:

LEO PHARMA INC

ATC code:

D07CC01

INN (International Name):

BETAMETHASONE AND ANTIBIOTICS

Dosage:

2%; 0.1%

Pharmaceutical form:

CREAM

Composition:

FUSIDIC ACID 2%; BETAMETHASONE (BETAMETHASONE VALERATE) 0.1%

Administration route:

TOPICAL

Units in package:

15G/30G

Prescription type:

Prescription

Therapeutic area:

ANTIBIOTICS

Product summary:

Active ingredient group (AIG) number: 0245421003; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-04-12

Summary of Product characteristics

_FUCIBET® (fusidic acid and betamethasone valerate) PM, version 1.0_
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_Template Date: June 2017 _
_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FUCIBET®
Fusidic acid and Betamethasone valerate cream
Cream, 2% (w/w) fusidic acid / 0.1% (w/w) betamethasone (as valerate),
Topical
Topical Antibiotic / Corticosteroid (D07CC01)
LEO Pharma Inc.
Thornhill, Ontario
L3T 7W8
www.leo-pharma.com/canada
Date of Initial Approval:
April 12, 2018
Submission Control No: 203765
®Registered trademark of LEO Pharma A/S used under license by LEO
Pharma Inc., Thornhill, ON
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_FUCIBET® (fusidic acid and betamethasone valerate) PM, version 1.0 _
_Template Date: June 2017 _
_Page 2 of 21_
RECENT MAJOR LABEL CHANGES
Not Applicable
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................
2
TABLE OF CONTENTS
..................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 4
1
INDICATIONS
......................................................................................................
4
1.1
Pediatrics (6 to <18 years of age)
............................................................... 4
1.2
Geriatrics (≥ 65 years of age):
.....................................................................
4
2
CONTRAINDICATIONS
.......................................................................................
4
3
DOSAGE AND ADMINISTRATION
.....................................................................
5
3.1
Dosing
Considerations.................................................................................
5
3.2
Recommended Dose and Dosage Adjustment
............................................ 5
3.3
Administration
..............................................................................................
5
3.4
Missed Dose
.................................................................................