البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
GENTAMICIN SULFATE; PREDNISOLONE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D07CA03
CREAM
PREDNISOLONE 0.5 %; GENTAMICIN SULFATE 0.16 %
DERMAL
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
PREDNISOLONE AND ANTIBIOTICS
PREDNISOLONE AND ANTIBIOTICS
For the treatment of skin inflammation associated with bacterial infection.
2022-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only Aflumycin Cream Active ingredients and their quantities per dosage unit: Each tube contains: Prednisolone 0.5% Gentamicin sulfate 0.16% Inactive and allergenic ingredients in the medicine – see section 2 “Important information about some of the ingredients of the medicine” and section 6 “Further information” in the leaflet. Read the 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 for you. Do not pass it 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? The medicine is indicated for the treatment of skin inflammation associated with bacterial infection. Therapeutic group: The medicine contains two active ingredients: Gentamicin – a broad-spectrum aminoglycoside antibiotic. Prednisolone – corticosteroid with an anti-inflammatory effect. 2. BEFORE USING THE MEDICINE Do not use the medicine: • If you are sensitive )allergic( to the active ingredients or to any of the additional ingredients in this medicine. • Do not use in case of viral infections )e.g., herpes or chickenpox( or tuberculosis. • If you have a sensitivity to another topical corticosteroid. • Do not use to treat a skin reaction to vaccine administration. • Do not use to treat acne. • Do not use to treat skin ulcers. • Do not use to treat rosacea. • Do not use to treat atrophic skin disease. • Do not use to treat perioral dermatitis. Special warnings regarding use of the medicine • Before treatment with Aflumycin, tell the doctor if: - you are pregnant or planning to become pregnant - you are breastfeeding or planning to breastfeed - you are in need of facial skin treatment • Use Aflumycin on the skin only. Do n اقرأ الوثيقة كاملة
PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Aflumycin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Prednisolone 0.5% Gentamicin Sulfate 0.16% Aflumycin dermal cream contains Prednisolone 5 mg/g (0.5%) and Gentamicin Sulfate 1. 6 mg/g (0.16%). Excipients with known effect: Aflumycin contains Cetostearyl alcohol and Benzyl alcohol. For a full list of excipients, see Section 6.1 3. PHARMACEUTICAL FORM Dermal white cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of skin inflammation associated with bacterial infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Aflumycin is for external topical use only. Apply a thin layer to the affected skin area 4 times daily. A gradual dose reduction should be made, according to the physician instructions. If clinical improvement is not achieved by one week, the condition should be assessed. Infants and children under the age of 4 years The treatment duration should not exceed 3 weeks, especially in areas covered by diapers. ELDERLY (OVER 65 YEARS): No data available. PAEDIATRIC USE In infants and children, plastic pants and napkins may act as occlusive dressings and increase absorption. Because of children’s larger skin surface area to bodyweight ratio, paediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than adults. Chronic/long-term corticosteroid therapy may interfere with growth and development of children. Use of topical corticosteroids in children should be limited to the least amount required for therapeutic effect. EFFECTS ON LABORATORY TESTS No data available. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. - Aflumycin is contraindicated in viral diseases (e.g. vaccinia, varicella/herpes zoster) and when tuberculous or syphilitic processes and post-vaccination skin reactions are present in the area to be treated. - Aflumycin is contraindicated if rosacea, ulcera, atrophic ski اقرأ الوثيقة كاملة