Šalis: Pietų Afrika
kalba: anglų
Šaltinis: South African Health Products Regulatory Authority (SAHPRA)
Adcock Ingram Limited
See ingredients
CREAM
EACH 1 g CREAM CONTAINS DIFLUCORTOLONE VALERATE 1 mg ISOCONAZOLE NITRATE 10 mg
Registered
1982-04-11
PATIENT INFORMATION LEAFLET FOR TRAVOCORT 09 May 2023 SCHEDULING STATUS S4 TRAVOCORT, 10 MG / 1 MG, CREAM ISOCONAZOLE NITRATE / DIFLUCORTOLONE VALERATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING TRAVOCORT • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other health care provider. • TRAVOCORT has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What TRAVOCORT is and what it is used for 2. What you need to know before you use TRAVOCORT 3. How to use TRAVOCORT 4. Possible side effects 5. How to store TRAVOCORT 6. Contents of the pack and other information 1. WHAT TRAVOCORT IS AND WHAT IT IS USED FOR 1 g TRAVOCORT contains isoconazole nitrate 10 mg and 1 mg diflucortolone valerate in an easy to remove low fat base emulsion. The active substances in TRAVOCORT are isoconazole nitrate and diflucortolone valerate. Other excipients include: White soft paraffin, liquid paraffin, cetostearyl alcohol, polysorbate 60, sorbitan stearate, disodium edetate dihydrate, purified water. PATIENT INFORMATION LEAFLET FOR TRAVOCORT 09 May 2023 TRAVOCORT is an anti-fungal medicine (an antimycotic) and an anti-inflammatory medicine (a corticosteroid) formulated as a cream to be used on the skin. One of TRAVOCORT's active ingredients, isoconazole nitrate, is effective against dermatophytes and yeasts, yeast-like fungi (including the causative organism of pityriasis versicolor) and moulds, as well as against the causative organism of erythrasma. The other active ingredient, diflucortolone valerate, suppresses inflammatory and allergic skin reactions. TRAVOCORT is used for the initial or interim treatment of those superficial fungal infections of the skin which are accompanied by highly inflammatory or eczematous skin conditions, e.g., in the region of the hands, the interdigital spaces of the feet, and in t Perskaitykite visą dokumentą
PROFESSIONAL INFORMATION FOR TRAVOCORT 09 May 2023 SCHEDULING STATUS S4 1. NAME OF THE MEDICINE TRAVOCORT, 10 MG / 1 MG, CREAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g TRAVOCORT contains isoconazole nitrate -imidazole, nitrate) 10 mg and diflucortolone valerate 1 mg in an easy-to-remove low fat base oil water emulsion. Excipients with known effect: cetostearyl alcohol For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. White to slightly yellowish opaque cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infections of hairless and hairy skin, e.g. in the region of the hands, the interdigital spaces of the feet, and in the inguinal and genital regions. Because of the addition of diflucortolone valerate, TRAVOCORT is indicated for the initial or intermediate treatment of those fungal diseases which are accompanied by highly inflammatory or eczematous skin conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY TRAVOCORT should be applied twice daily to the diseased areas of skin. In infections of the interdigital spaces it is often advisable to place a strip of gauze smeared with TRAVOCORT between _ _ 09 May 2023 the toes or fingers. The treatment with TRAVOCORT must be terminated after regression of the inflammatory or eczematous skin condition and the therapy continued or followed up with the isoconazole nitrate preparation without corticoid additive. This applies in particular for use in inguinal and genital regions. If a secondary microbial skin infection is present suitable concomitant anti-microbial therapy should be instituted. If fungal infections are present, a topically active antimycotic should be applied. _PAEDIATRIC POPULATION_ No data are available. METHOD OF ADMINISTRATION Cutaneous use. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. • Tuberculous or syphilitic processes in the area to be treated; virus diseases (e.g. varicella, herpes zoster), rosacea, perioral dermatitis and Perskaitykite visą dokumentą