Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOBETASOL PROPIONATE
Top Biopharma Sdn Bhd
CLOBETASOL PROPIONATE
15 gm
POLIPHARM CO., LTD.
Consumer Medication Information Leaflet (RiMUP) 1 BIO CLOBETATE CREAM 0.05%w/w Clobetasol propionate (0.05% w/w) What is in this leaflet 1. What Bio Clobetate cream is used for 2. How Bio Clobetate cream works 3. Before you use Bio Clobetate cream 4. How to use Bio Clobetate cream 5. While you are using it 6. Side effects 7. Storage and Disposal of Bio Clobetate cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What Bio Clobetate cream is used for Bio Clobetate cream relieves the symptoms of certain skin problems frequently relapsing eczemas psoriasis (thickened patches of inflamed, red skin, often covered by silvery scales) lichen planus (a skin disease that causes itchy, reddish- purple, flat- topped bumps on the wrists, forearms or lower legs) discoid lupus erythematosus (a disease of the skin most often affecting the face, ears and scalp causing scarring and increased sensitivity of the affected skin to sunlight) conditions which do not respond satisfactorily to less potent steroids. For children over the age of one year Bio Clobetate cream is used for dermatitis that has not responded to milder steroid creams. How Bio Clobetate cream works The name of your medicine is Bio Clobetate cream. Bio Clobetate cream contains clobetasol propionate which belongs to a group of medicines called steroids. Steroids help to reduce redness, swelling and irritation of the skin. Before you use Bio Clobetate cream - When you must not use it Don’t use Bio Clobetate cream to treat any of the following skin problems, it could make them worse: infected skin (unless the infection is being treated with an anti-infective medicine at the same time) acne rosacea (a facial skin condition where the nose, cheeks, chin, forehead or entire face are unusually red, with or without tiny visible blood vessels, bumps (papules) or pus- filled bumps (pustules)) rashes around the mouth itchy skin which is not inflamed around the anus or genitals (penis and Perskaitykite visą dokumentą
Font size: 10, Times New Roman PACKAGE INSERT BIO CLOBETATE CREAM 0.05%w/w (Clobetasol Propionate 0.05%w/w) Name and Strength of active ingredient BIO CLOBETATE CREAM 0.05%w/w contains Clobetasol propionate 0.05%w/w. Product description BIO CLOBETATE CREAM 0.05%w/w is smooth, white, water soluble, characteristic odor cream. BIO CLOBETATE CREAM 0.05%w/w also contains Chlorocresol 0.1%w/w as preservative. Pharmacological properties Pharmacodynamics ATC code D07AD Corticosteroids, very potent (group IV) Mechanism of action Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late phase allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells and eosinophils, and inhibiting the metabolism of arachidonic acid. Pharmacodynamic effects Topical corticosteroids, have anti-inflammatory, antipruritic, and vasoconstrictive properties. Pharmacokinetics Absorption Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Mean peak plasma clobetasol propionate concentrations of 0.63 nanograms/ml occurred in one study eight hours after the second application (13 h after an initial application) of 30 g clobetasol propionate 0.05 % ointment to normal individuals with healthy skin. Following the application of a second dose of 30 g clobetasol propionate cream 0.05 %, mean peak plasma concentrations were slightly higher than the ointment and occurred 10 h after application. In a separate study, mean peak plasma concentrations of approximately 2.3 nanograms/ml and 4.6 nanograms/ml occurred respectively in patients with psoriasis and eczema three hours after a single application o Perskaitykite visą dokumentą