FUCICORT® LIPID CREAM

Country: Singapor

Lingwa: Ingliż

Sors: HSA (Health Sciences Authority)

Ingredjent attiv:

Betamethasone valerate; Fusidic acid

Disponibbli minn:

DKSH SINGAPORE PTE. LTD.

Kodiċi ATC:

D07CC01

Għamla farmaċewtika:

CREAM

Kompożizzjoni:

Betamethasone valerate 1mg/g; Fusidic acid 20mg/g

Rotta amministrattiva:

TOPICAL

Tip ta 'preskrizzjoni:

Prescription Only

Manifatturat minn:

LEO Laboratories Ltd

L-istatus ta 'awtorizzazzjoni:

ACTIVE

Data ta 'l-awtorizzazzjoni:

2019-06-18

Karatteristiċi tal-prodott

IIE007-01 - 175 x 280 mm
280 mm
175 mm
Calcipotriene. Conoptal
®
,
Daivonex
®
,
Dovonex
®
, Daivobet
®
, Dovobet
®
Taclonex
®
,
Psorcutan
®
, Token
®
,
Fucidin
®
, Fucidin
®
H, Fucicort
®
,
Fucibet
®
, Fucithalmic
®
, Isathal
®
,
Isathalmic
®
, Verutex
®
, Verutex
®
B
1 column
2 columns
Comments:
INS007-00 - 22/09/2017 DVR - Moved details about itemnumber
IIE007-01 - 03/06/2018 - OMA - Updated for CI project (CAPA 173674),
changed reference from INS005 to IIE005-01
Revision info:
Used for:
OMA
11/06/2018
Insert
175 x 280mm
IIE007-01
20/01/2004
PSR
100%
1 column, Space for text: 155 mm x 260 mm
2 columns, Space for text: 2 x 75 mm x 260 mm
font: OCRB, 8 pt., kerning Quark +10 / InDesign +50, rotate 90%
Approval:
Date:
Production site approval:
Graphic approval:
Material number and pharmacode must be printed on both sides,
469
065418-XX
469
NAME OF THE MEDICINAL PRODUCT
FUCICORT® LIPID 20 MG/G + 1 MG/G CREAM
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusidic acid 20 mg/g and betamethasone 1 mg/g (as betamethasone
valerate).
Excipients: contains cetostearyl alcohol 40 mg/g, methyl
parahydroxybenzoate (E218) 1 mg/g, propyl parahydroxybenzoate (E216)
0.2 mg/g and potassium
sorbate 2.5 mg/g.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
A white highly viscous oil-in-water emulsion cream.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Use in inflammatory dermatoses where bacterial infection is present or
likely to occur.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Apply a small quantity to the affected area twice daily until a
satisfactory response is obtained. A single treatment course should
not normally exceed 2 weeks.
4.3. CONTRAINDICATIONS
Hypersensitivity to fusidic acid/sodium fusidate, betamethasone
valerate or any of the excipients listed in section 6.1.
Due to the content of corticosteroid, Fucicort® Lipid is
contraindicated in the following conditions: Systemic fungal
infections
Primary skin infections caused by fungi, virus or bacteria, either
untreate