Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betamethasone (betamethasone 17-valerate), gentamicin (gentamicin sulfate)
Schering-Plough Labo N.V.
D07CC01
betamethasone (betamethasone 17-valerate), gentamicin (gentamicin sulfate)
1mg/g+ 1mg/g
cream
aluminium tube 30g
Prescription
Registered
2021-08-04
[Organon] Proprietary SUMMARY OF PRODUCT CHARACTERISTICS 2 [Organon] Proprietary 1. NAME OF THE MEDICINAL PRODUCT CELESTODERM-V ® WITH GARAMYCIN ® INTERNATIONAL NONPROPRIETARY NAME: betamethasone and antibiotics. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of cream contains _active ingredients: _1 g of cream contains 1,220 mg betamethasone valerate equivalent to 1 mg of betamethasone and gentamicin sulfate equivalent to 1 mg (1000 I.U.) of gentamicin. _excipients_: white soft paraffin, cetostearylalcohol, liquid paraffin, macrogol cetostearyl ether, sodium dihydrogen phosphate dihydrate, chlorocresol, phosphoric acid, sodium hydroxide/ phosphoric acid, purified water. 3. PHARMACEUTICAL FORM Cream. DESCRIPTION: homogeneous, white to off-white soft cream without foreign inclusions PHARMACOTHERAPEUTIC GROUP. Corticosteroids, dermatological preparations. Corticosteroids, combinations with antibiotics. ATC code: D07С C01. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION(S) Treatment of skin diseases requiring treatment with a potent glucocorticoid in the presence of superinfection with gentamicin-susceptible organisms 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: 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 seborrheic skin diseases, in acute stage. Duration of use: The duration of treatment with cream should not exceed 7-10 days (7 days in children) because of the gentamicin content. As soon as medically confirmed that combined therapy is no longer necessary (i.e., either a dermatosis requiring a strong-acting glucocorticoid or a superinfection with gentamicin- susceptible organisms is no longer present), treatment should be continued on the basis of single-agent therapy with a glucocorticoid (p Baca dokumen lengkap