Pays: Arménie
Langue: anglais
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
betamethasone (betamethasone dipropionate), clotrimazole, gentamicin (gentamicin sulfate)
Schering-Plough Labo N.V.
betamethasone (betamethasone dipropionate), clotrimazole, gentamicin (gentamicin sulfate)
0,5mg/g+10mg/g+1mg/g
cream
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT TRIDERM CREAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _active ingredients:_ betamethasone, clotrimazole, gentamycin; 1 g of cream contains betamethasone 0.5 mg (0,643 mg as betamethasone dipropionate), 10 mg clotrimazole and 1.0 mg gentamycin (as gentamycin sulfate); _excipients: _ liquid paraffin, white soft paraffin, cetostearyl alcohol, propylene glycol, macrogol cetostearyl ether, benzyl alcohol, sodium dihydrogen phosphate dihydrate, phosphoric acid, sodium hydroxide, phosphoric acid, purified water._ _ 3. PHARMACEUTICAL FORM Cream. PHARMACOTHERAPEUTIC GROUP. Topical corticosteroid in combination with other agents for treatment of dermatological deceases. ATC code D07С01. 4. CLINICAL PARTICULARS. _ _ 4.1. INDICATIONS. TRIDERM is indicated for the treatment of corticosteroid-responsive dermatoses when complicated by infections caused by bacteria and/or fungi or when the possibility of such infections is suspected. The cream is suitable for the use of oozing lesions. 4.2. CONTRAINDICATIONS. Topical corticosteroids are contraindicated in skin infections (viral, bacterial [including tuberculosis] and fungal origin), reaction to vaccines, skin ulcers and acne. Cream should not be applied for face in the case of rosacea or perioral dermatitis. _ _ Hypersensitivity to any of active components or ingredients of the preparation, other aminoglycosides (polyvalent allergy to gentamycin) or imidazole derives (polyvalent allergy to clotrimazole). Triderm is not indicated for use with occlusive dressing. Triderm should not be applied on mucosae, skin around eyes and close to eyes. _ _ 4.3 POSOLOGY AND METHOD OF ADMINISTRATION. _Adolescents and adults. _ TRIDERM should be applied to cover completely the affected and surrounding skin areas twice daily. Duration of therapy varies depending upon the results of clinical examination, microbiological testing and patient response to treatment. In the case of foot mycoses a longer course of treatment (2-4 Lire le document complet