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26 ©2002 Novartis Pharma AG 09/02 Introducing the New Non-Steroid Cream for the Treatment of Mild to Moderate Atopic Eczema Eczema relief. Flare control. Summary of product characteristics as agreed by 13 member states of the European Union. Indication: Elidel is indicated in patients with mild to moderate atopic dermatitis (eczema) aged 2 years and over for short-term treatment of signs and symptoms and intermittent long-term treatment for prevention of progression to flares. Posology and administration: Elidel should be prescribed by physicians with experience in the topical treatment of atopic dermatitis. Data from clinical studies support intermittent treatment with Elidel for up to 12 months. If no improvement occurs after 6 weeks, or in case of disease exacerbation, Elidel should be stopped and further therapeutic options considered. Contraindications: Hypersensitivity to pimecrolimus, other macrolactams or to any of the excipients. Special warnings and precautions for use: Elidel should not be applied to areas affected by acute cutaneous viral infections (herpes simplex, chicken pox). Elidel has not been evaluated for its efficacy and safety in the treatment of clinically infected atopic dermatitis. Before commencing treatment with Elidel, clinical infections at treatment sites should be cleared.While patients with atopic dermatitis are predisposed to superficial skin infections including eczema herpeticum (Kaposi's varicelliform eruption), treatment with Elidel may be associated with an increased risk of skin herpes simplex virus infection, or eczema herpeticum (manifesting as rapid spread of vesicular and erosive lesions). In the presence of herpes simplex skin infection, Elidel treatment at the site of infection should be discontinued until the viral infection has cleared.Although patients treated with Elidel experienced overall a lower incidence of bacterial skin infections as compared to patients treated with the vehicle, patients with severe atopic dermatitis may have an increased risk of skin bacterial infections (impetigo) during treatment with Elidel. Use of Elidel may cause mild and transient reactions at the site of application, such as a feeling of warmth and/or burning sensation. If the application site reaction is severe, the risk-benefit of treatment should be re-evaluated. Care should be taken to avoid contact with eyes and mucous membranes. If accidentally applied to these areas, the cream should be thoroughly wiped off and/or rinsed off with water.The use of Elidel under occlusion has not been studied in patients. Occlusive dressings are not recommended.As the safety of Elidel has not been established in erythrodermic patients, the use of the product in this patient population cannot be recommended. Elidel has not been studied in patients with Netherton's syndrome. Due to the potential for increased systemic absorption of pimecrolimus, Elidel is not recommended in patients with Netherton's syndrome. Physicians should advise patients on appropriate sun protection measures, such as minimisation of the time in the sun, use of sunscreen product and covering the skin with appropriate clothing. Elidel has not been studied in immunocompromised patients and in patients with evidence of skin malignancies and there is no data to support its use in these patients. Long-term effect on the local skin immune response and on the incidence of skin malignancies is unknown. Elidel contains cetyl alcohol and stearyl alcohol which may cause local skin reactions. Elidel also contains propylene glycol, which may cause skin irritation.
XXIII EAACI Congress 12-16 June 2004 Amsterdam Young investigators at the frontiers of allergy Come and visit the XXIII EAACI Congress in Amsterdam. We offer you a well balanced scientific programme tailored to the needs of clinicians and basic scientists, of young investigators and established senior researchers, of physicians and allied health professionals. Attend the Allergy Forums and the unopposed poster sessions focused on young investigators. Go to the Year in Review sessions to have an update of scientific highlights. Amsterdam is the place to be. This international but yet compact city allows you to enjoy all kinds of culture or simply provides you with the pleasure of a relaxed stay. Visit www.congrex.com/eaaci2004 27
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