Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betamethasone (betamethasone 17-valerate), gentamicin (gentamicin sulfate)
Schering-Plough Labo N.V.
betamethasone (betamethasone 17-valerate), gentamicin (gentamicin sulfate)
1mg/g+1mg/g
cream
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CELESTODERM-V ® WITH GARAMYCIN ® 1 mg/g + 1 mg/g, Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances: gentamicin sulfate, betamethasone valerate (Ph. Eur.) 1 g CELESTODERM-V ® WITH GARAMYCIN ® contains: 1.22 mg betamethasone valerate (Ph. Eur.) (equivalent to 1 mg of betamethasone) 1.67 mg of gentamicin sulfate (equivalent to 1 mg of gentamicin) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION(S) Corticosteroid-responsive skin diseases in the presence of bacterial superinfection for which gentamicin is indicated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Unless otherwise prescribed, Cream is applied 2-3 times daily. The frequency may be reduced as the condition improves. Method of administration: A thin film of Cream should be applied to the affected areas of skin. The method of administration should be adjusted to the skin type and stage of the disease. Cream is recommended in particular for greasy skin, weeping, itching, burning and seborrhoic skin diseases, in body folds, in acute stage. Duration of use: The duration of use of Cream should not exceed more than a couple of days. 4.3 CONTRAINDICATIONS Cream is contraindicated in those patients hypersensitive to the active substances betamethasone valerate, gentamicin sulfate, chlorocresol or to any of the excipients listed in section 6.1 and in patients hypersensitive to other corticosteroids or aminoglycoside antibiotics. Do not use in the presence of skin diseases caused primarily by bacteria or viruses. Cream is contraindicated in the presence of cutaneous tuberculosis and viral infections. Cream is not indicated for use on the eye or ear. 2 Because of the possibility of absorption of the active substance, long-term treatment, application on extensive areas of skin and/or treatment using occlusive dressings should be avoided. Do not use in patients with fungal diseases of the skin Prečítajte si celý dokument