البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
HYDROCORTISONE; MICONAZOLE NITRATE
J-C HEALTH CARE LTD
D07CA01
CREAM
HYDROCORTISONE 10 MG/G; MICONAZOLE NITRATE 20 MG/G
TOPICAL
Required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
HYDROCORTISONE AND ANTIBIOTICS
HYDROCORTISONE AND ANTIBIOTICS
Infections of the skin caused by dermatophytes or candida species in which inflammatory symptoms are prominent.
2020-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only NAME OF THE MEDICINE, ITS FORM AND STRENGTH DAKTACORT ® CREAM ACTIVE INGREDIENTS AND CONCENTRATIONS Miconazole nitrate 20 mg/g (2% w/w); hydrocortisone 10 mg/g (1% w/w) Inactive and allergenic ingredients in the preparation – see in section 2 “Important information about some of the ingredients of the medicine” and section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Daktacort Cream is a cream for the treatment of skin infections caused by fungi, including yeasts. Daktacort Cream is particularly intended for the treatment of infections accompanied by pronounced redness and itching. THERAPEUTIC GROUP: Miconazole nitrate – an antifungal from the imidazole group, which works by destroying both the fungi that cause infection and some of the associated bacteria. Hydrocortisone – a low-potency anti-inflammatory steroid for external use, which reduces inflammation, swelling, redness and itching of the skin. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are sensitive )allergic( to the active ingredients or any of the additional ingredients contained in the medicine, or to other similar antifungal medicines. For a list of the additional ingredients, see section 6 “Further Information”. • you have other skin problems, such as cold sores, herpes, chickenpox or shingles. Use this preparation only for the skin problem you have shown to the doctor. Do not use this preparation if any of these conditions apply to you. If you are uncertain, talk to the doctor or ph اقرأ الوثيقة كاملة
1 Daktacort cream_SPC_03_2021_sub 1. NAME OF THE MEDICINAL PRODUCT DAKTACORT CREAM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Miconazole nitrate 2% w/w and hydrocortisone 1% w/w. Excipients with known effect Daktacort ceam contains 2 mg/g benzoic acid (E210) 15 g: This medicine contains 30 mg benzoic acid in each tube of 15 g cream which is equivalent to 2 mg/g cream. Daktacort ceam contains 0.052 mg/g butylated hydroxyanisole (E320). For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White, homogeneous cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Infections of the skin caused by dermatophytes or candida species in which inflammatory symptoms are prominent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical administration. The properties of Daktacort ceam indicate it particularly for the initial stages of treatment . Because of its corticosteroid content avoid long-term treatment with Daktacort ceam. Daktacort ceam should be applied topically to the lesion once to twice daily. It should be rubbed in gently until it has been completely penetrated into the skin. The treatment with Daktacort ceam (or subsequently with miconazole nitrate 20 mg/g topical cream) should be continued without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks). Elderly Natural thinning of the skin occurs in the elderly, hence corticosteroids should be used sparingly and for short periods of time. Paediatrics In infants and children, caution is advised when Daktacort ceam is applied to extensive surface areas or under occlusive dressings including baby napkins (diapers). 2 Daktacort cream_SPC_03_2021_sub In infants, long term continuous topical corticosteroid therapy should be avoided (see _Section 4.4_ ). 4.3 CONTRAINDICATIONS True hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives, hydrocortisone or to any of the excipients listed in section 6.1. Tubercular or viral infections of the skin or those caused by Gram-negative bacteria. 4.4 SPECIA اقرأ الوثيقة كاملة