Land: Malaysia
Sprache: Englisch
Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOBETASONE BUTYRATE
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
CLOBETASONE BUTYRATE
50 x 15 gm
MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 CLOBUTRATE CREAM 0.05% W/W Clobetasone Butyrate 0.05% w/w WHAT IS IN THIS LEAFLET: 1. What Clobutrate Cream 0.05% w/w is used for 2. How Clobutrate Cream 0.05% w/w works 3. Before you use Clobutrate Cream 0.05% w/w 4. How to use Clobutrate Cream 0.05% w/w 5. While you are using it 6. Side Effects 7. Storage and Disposal of Clobutrate Cream 0.05% w/w 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CLOBUTRATE CREAM 0.05% W/W IS USED FOR Clobutrate Cream relieves the symptoms of certain skin problems. These include: atopic eczema skin inflammation including seborrhoeic dermatitis (scaly patches, red skin and stubborn dandruff that mainly affect the scalp) and a type of skin reaction triggered by exposure to sunlight (photodermatitis) skin rash due to allergy or a substance that irritates your skin (irritant and allergic contact dermatitis) nappy rash inflammation of the outer ear canal prurigo nodularis (itchy nodules on the skin) insect bites HOW CLOBUTRATE CREAM 0.05% W/W WORKS? Clobutrate cream contains a medicine called clobetasone butyrate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation. BEFORE YOU USE CLOBUTRATE CREAM 0.05% W/W - _When you must not use it _ If you are allergic (hypersensitive) to Clobetasone Butyrate or any of the other ingredients of Clobutrate Cream 0.05% w/w. If you are planning to use it for the treatment of untreated cutaneous infection, rosacea (redness of skin), acne vulgaris, pruritus without inflammation. - _Before you start to use it _ You must tell your doctor if: you have allergies to any medicine which you have taken previously to treat your current condition. you are pregnant, trying to become pregnant or breast-feeding. _Pregnancy and breastfeeding _ Safety of its use during prenancy and breastfeeding have not been established. Women who are pregnant and breastfeeding should consult a doc Lesen Sie das vollständige Dokument
7218-00 CLOBUTRATE CREAM 0.05% W/W NAME AND STRENGTH OF ACTIVE INGREDIENT(S): Clobetasone Butyrate 0.05% w/w PRODUCT DESCRIPTION: Clobutrate Cream 0.05% w/w : A smooth white cream in aluminium tubes with white caps. PHARMACODYNAMICS: 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 mechanism 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 absoprtion 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. DISTRIBUTION The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary due to the fact that circulating levels are well below the level of detection. METABOLISM Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver. ELIMINATION Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile._ _ COMPOSITION: Clobetasone Butyrate 0.05% w/w: Each gram of cream contains 0.5mg of Clobetasone Butyrate INDICATION: Clobutrate Cream is a moderately potent topical corticosteroid indicated for adults, elderly, children and infants for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. These include the following: - Atopic d Lesen Sie das vollständige Dokument