Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
DESONIDE
Galderma (UK) Ltd
DESONIDE
0.05 %w/w
Cream
Withdrawn
2008-03-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sterax Cream 0.05% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Desonide 0.05% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream White, shiny cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the cutaneous treatment of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as psoriasis, eczema, and other mainly inflammatory dermatoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For external use only. Adults, children and the elderly: To be applied once or twice a day depending on the severity of the condition. Squeeze the tube gently at its base to place a quantity of cream on the fingertips sufficient to cover the area to be treated. Wash hands thoroughly and replace the cap tightly after use. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the components of the formulation. Ulcerated lesions. Acne and rosacea. Conditions for which cutaneous corticosteroid therapy is contra-indicated, notably skin infections of bacterial, viral, fungal and parasitic origin, even when these include an inflammatory response. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Several preclinical studies were performed to establish the safety of cutaneous application of desonide. From these studies and based on the general knowledge of the adverse reactions associated with the use of topical corticosteroids, particularly their potential systemic action on the hormonal system, it is recommended that the application of Sterax on large areas or under occlusive dressings should be limited. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/07/2006_ _CRN 2025998_ _page number: 1_ In paediatric use, pati Baca dokumen lengkap