Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
ERYTHROMYCIN
NEOPHARM LTD
D10AF02
SOLUTION - EXTERNAL
ERYTHROMYCIN 2 %
DERMAL
Required
ALMIRALL HERMAL GMBH, GERMANY
ERYTHROMYCIN
ERYTHROMYCIN
All forms of acne, particularly inflammatory forms with papules and pustules.
2014-06-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is to be supplied by physician’s prescription only AKNEMYCIN Solution for topical use – for external use 10g solution/0.2g Erythromycin COMPOSITION: ACTIVE INGREDIENT AND ITS CONCENTRATION –10g of solution for application to the skin contain Erythromycin 0.2g. Inactive ingredients and allergens in the product: See section “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains essential information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed for your treatment. 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 THIS MEDICINE INTENDED FOR? For external antibiotic treatment of all forms of acne ( skin lesions) particularly inflammatory forms with papules and pustules. THERAPEUTIC GROUP: Erythromycin – Macrolide antibiotics. 2. BEFORE USING THIS MEDICINE .X. DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredient or to any of the other ingredients that this medicine contains The inactive ingredients are listed in the section "Additional Information". .!. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE BEFORE THE TREATMENT WITH AKNEMYCIN, TELL YOUR PHYSICIAN: If you are sensitive to any food or medicine Oxidants (oxidizing agents) and water impair the efficacy of the product. Do not light a cigarette or expose yourself to flames until product has completely dried. IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INCLUDING NONPRESCRIPTION MEDICATIONS AND FOOD SUPPLEMENTS, INFORM YOUR PHYSICIAN OR PHARMACIST. PREGNANCY AND BREASTFEEDING If you are pregnant or breast-feeding, you should consult a physician or pharmacist before using this medicine. 3. HOW SHOULD YOU USE THE MEDICINE? Always use according to the physician's instructions. You shoul Baca dokumen lengkapnya
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aknemycin ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 10 g of solution contains 0.2 g of erythromycin. Structural formula of erythromycin Excipient with known effect: This medicinal product contains 752 mg alcohol (ethanol) per ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous solution Aknemycin is a clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS All forms of acne, in particular inflammatory forms with papules and pustules. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Generally the solution should be applied twice a day. Method of Administration The bottle has a special applicator; with this Aknemycin can be applied directly on to the skin. Page 2 of 6 The applicator bottle is prepared for use each time by pressing vigorously on the applicator beforehand with the reversed cap. This releases the safety mechanism and Aknemycin can be applied. Treatment with Aknemycin should not be longer than 4 – 6 weeks. 4.3 CONTRAINDICATIONS Aknemycin must not be used in cases of - hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other macrolides, rare serious allergic reactions, including acute generalised exanthematous pustulosis (AGEP) have been reported. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. Aknemycin should not be allowed to get into the eyes. This medicinal product contains 752 mg alcohol (ethanol) per ml. It may cause burning sensation on damaged skin. Do not light a cigarette or expose yourself to open flames until the medicine has dried completely 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known to date. 4.6 FERTILITY, PREGNANCY AND LACTATI Baca dokumen lengkapnya