País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
Betamethasone valerate; Fusidic acid
DKSH SINGAPORE PTE. LTD.
D07CC01
CREAM
Betamethasone valerate 1mg/g; Fusidic acid 20mg/g
TOPICAL
Prescription Only
LEO Laboratories Ltd
ACTIVE
2019-06-18
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 Leia o documento completo