Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
tacrolimus
Astellas Pharma GmbH
D11AX14
tacrolimus
Other dermatological preparations
Dermatitis, Atopic
Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids.Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).
Revision: 10
Withdrawn
2002-02-28
Medicinal product no longer authorised 34 B. PACKAGE LEAFLET Medicinal product no longer authorised 35 PACKAGE LEAFLET: INFORMATION FOR THE USER PROTOPY 0.03% OINTMENT Tacrolimus monohydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Protopy is and what it is used for 2. Before you use Protopy 3. How to use Protopy 4. Possible side effects 5. How to store Protopy 6. Further information 1. WHAT PROTOPY IS AND WHAT IT IS USED FOR The active substance of Protopy, tacrolimus monohydrate, is an immunomodulating agent. Protopy 0.03% ointment is used to treat moderate to severe atopic dermatitis (eczema) in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids and in children (2 years of age and older) who failed to respond adequately to conventional therapies such as topical corticosteroids. In atopic dermatitis, an over-reaction of the skin’s immune system causes skin inflammation (itchiness, redness, dryness). Protopy alters the abnormal immune response and relieves the skin inflammation and the itch. 2. BEFORE YOU USE PROTOPY DO NOT USE PROTOPY - If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Protopy or to macrolide antibiotics (e.g. azithromycin, clarithromycin, erythromycin). TAKE SPECIAL CARE WITH PROTOPY - Protopy ointment is not approved for children younger than 2 years of age. Therefore it should not be used in this age group. Please consult your doctor. - The effect of treatment with Protopy on the developing immune system in children, especially the you Lue koko asiakirja
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Protopy 0.03% ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of Protopy 0.03% ointment contains 0.3 mg of tacrolimus as tacrolimus monohydrate (0.03%). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ointment A white to slightly yellowish ointment. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Treatment of moderate to severe atopic dermatitis in children (2 years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Protopy should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Treatment should be intermittent and not continuous. Protopy ointment should be applied as a thin layer to affected areas of the skin. Protopy ointment may be used on any part of the body, including face, neck and flexure areas, except on mucous membranes. Protopy ointment should not be applied under occlusion (see section 4.4). Each affected region of the skin should be treated with Protopy until clearance occurs and then treatment should be discontinued. Generally, improvement is seen within one week of starting treatment. If no signs of improvement are seen after two weeks of treatment, further treatment options should be considered. Protopy can be used for short term and intermittent long term treatment. At the first signs of recurrence (flares) of the disease symptoms, treatment should be re-initiated. Protopy is not recommended for use in children below age of 2 years until further data are available. Use in children (2 years of age and above) Treatment should be started twice a day for up to three weeks. Afterwards the fr Lue koko asiakirja