Nazione: Armenia
Lingua: inglese
Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
isoconazole (isoconazole nitrate), diflucortolone (diflucortolone valerate)
Bayer Healthcare Manufacturing S.r.l.
առկա չէ (D07XC)
isoconazole (isoconazole nitrate), diflucortolone (diflucortolone valerate)
10mg/g+ 1mg/g
cream for external use
15g aluminium tube
Prescription
Registered
2019-01-31
Page 1 of 5 Summary of Product Characteristics Travocort 0.1% + 1% cream SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Travocort 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Travocort cream contains: Isoconazole nitrate 10 mg (1%) Diflucortolone valerate 1 mg (0.1%) 3. PHARMACEUTICAL FORM Cream 4. CLINICAL PARTICULARS _4.1 _ _THERAPEUTIC INDICATIONS _ Superficial fungal infections of the skin which are accompanied by highly inflammatory or eczematous skin conditions: - ringworm of the body including interdigital spaces and genital regions localization, - skin candidamycosis - pityriasis versicolor. _4.2 _ _POSOLOGY AND METHOD OF ADMINISTRATION _ Unless otherwise prescribed by your physician, Travocort should be applied twice a day. Maximum length of treatment is 2 weeks. After regression of the inflammatory skin condition, the therapy followed up with the corticoid-free preparation. _Paediatric population _ Only limited data is available on the safety and efficacy of Travocort in children under 12 years of age. The safety and efficacy in children under 2 years of age have not yet been established. _4.3 _ _CONTRAINDICATIONS _ Hypersensitivity to the active substance or to any of the excipients. Presence of tubercular, syphilitic or viral lesions (chicken pox, shingles), rosacea, perioral dermatitis and skin reactions to vaccinations in the area to be treated. _4.4 _ _SPECIAL WARNINGS AND PRECAUTIONS FOR USE _ It is advisable to associate a specific additional treatment when treating mixed infections caused by gram-negative bacteria. When applying the preparation to the face, it should not come into contact with the eyes. Page 2 of 5 Summary of Product Characteristics Travocort 0.1% + 1% cream The use of topical glucocorticoids on large areas of the body, or for prolonged periods of time, particularly under occlusive bandages, can increase the risk of systemic unwanted effects. As is known for systemic glucocorticoids, glaucoma can appear with the use of topical glucocorticoids (for exam Leggi il documento completo