Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
KETOCONAZOLE
PROPHARM (M) SDN. BHD.
KETOCONAZOLE
25ml mL
CHAROEN BHAESAJ LAB CO., LTD.
FUNGINOX SOLUTION Ketoconazole (2% w/v) _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Funginox Solution is used for 2. How Funginox Solution works 3. Before you use Funginox Solution 4. How to use Funginox Solution 5. While you are using it 6. Side effects 7. Storage and Disposal of Funginox Solution 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FUNGINOX SOLUTION IS USED FOR It is used for fungal and yeast infections of the skin and scalp. HOW FUNGINOX SOLUTION WORKS Funginox Solution contains ketoconazole, which is an antifungal agent. It kills the fungus and yeasts that causes the infections. BEFORE YOU USE FUNGINOX SOLUTION - _When you must not use it _ _ _ Do not take this medicine if you are allergic to ketoconazole or any other ingredient of this medicine (listed in product description). - _Before you start use it _ _ _ • This preparation contains sodium metabisulfite that may cause allergic reaction. Do not use if known to be hypersensitive to any bisulfites. • Please consult your doctor or pharmacist if you are pregnant, planning for pregnancy or breast- feeding before using any medicine. - _Taking other medicines _ _ _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE FUNGINOX SOLUTION - _How much to use _ _ _ • Clean and dry the affected area, before spraying Funginox Solution. • Spray or apply sufficient amount of the solution to the affected areas and immediate surrounding area. Gently rub in as directed by your doctor or pharmacist. • Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help. - _When to use it _ _ _ Use once or twice daily or as directed by your doctor or pharmacist. For infection on the sca Baca dokumen lengkap
93 mm 296 mm DESCRIPTION Funginox Solution is a clear, pink liquid packed in an opaque glass bottle which is closed with a white plastic cap. A white plastic sprayer which is packed separately from the glass container is enclosed within the same cardboard box. NAME AND STRENGTH OF ACTIVE INGREDIENT Funginox Solution contains Ketoconazole 2% PHARMACODYNAMICS Ketoconazole, a synthetic imidazole dioxolane derivative, is a broad-spectrum antifungal agent. It has a potent antimycotic activity against dermatophytes namely, Trichophyton sp.. Epidermophyton floccosum and microsporum sp. and yeasts. The effect on Pityrosporum sp.is especially very distinctive. PHARMACOKINETICS Percutaneous absorption of Ketoconazole topical solution spray is negligible since blood levels cannot be detected even after prolonged use. There should not be any systemic effect. INDICATION Topical treatment and prophylaxis of dermatophyte infections of the skin: Tinea Corporis, tinea cruris, tinea menus and tinea pedis due to Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis, Epidermophyton floccosum, cutaneous candidosis and tinea (pityriasis) versicolor, seborrhoeic dermatitis (a skin condition related with the presence of Pityrosporum ovale). Topical treatment and prophylaxis of infections of the scalp in which the yeast pityrosporum is involved e.g. pityriasis versicolor (localized), seborrhoeic dermatitis and pityriasis capitis (dandruff associated with fungal infections of the scalp). RECOMMENDED DOSE For topical treatment of dermatophyte infections of the skin: Tinea corporis, tinea cruris, tinea manus, tinea pedis, cutaneous candidosis and pityriasis versicolor : it is recommended that Funginox Solution should be gently sprayed or applied once daily to cover the affected and immediate surrounding area. SEBORRHEIC DERMATITIS: Funginox Solution should be sprayed or applied to the affected area once or twice daily depending on the severity of infection. DANDRUFF: Funginox Solution to be sprayed or applied on the scalp twic Baca dokumen lengkap