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
ointment
Prescription
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1 NAME OF THE MEDICINAL PRODUCT TRIDERM _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION_ _ _ _ _COMPOSITION_: _active ingredients:_ betamethasone, clotrimazole, gentamycin; 1 g of ointment contains betamethasone dipropionate equivalent to 0.5 mg betamethasone, 10 mg clotrimazole and gentamycin sulfate equivalent to 1.0 mg of gentamycin base; _excipients:_ liquid paraffin, white soft paraffin. 3. PHARMACEUTICAL FORM Ointment. PHARMACOTHERAPEUTIC GROUP. Topical corticosteroid in combination with other dermatological agents. 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 POSOLOGY AND METHOD OF ADMINISTRATION _Adolescents and adults. _ A thin film of TRIDERM should be applied to cover completely the affected and surrounding skin areas twice daily, in the morning and at night. 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 weeks) should be considered. _Children 2 to 12 years old. _ A small amounts apply on affected skin areas only and massage gently. Use no more than twice in a day with an interval at least 6-12 hours. Under the care of a physician only the ointment should be applied to face, neck, scalp, genital area, rectal area and intertrigo. Duration of treatment is limited to 5-7 days. See also sections “Precautions” and "Use in children". _ _ 4.3 CONTRAINDICATIONS Topical corticosteroids are contraindicated in skin infections (viral, bacterial [including tuberculosis] and fungal origin), reaction to vaccines, skin ulcers and acne. Ointment should not be applied for face in the case of rosacea or perioral dermatitis. _ _ Hypersensitivity to any of active Lire le document complet