Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE
TERAPUTICS SDN BHD
BETAMETHASONE
50 gm; 30 gm
TERAPUTICS SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ZONTRON BETASONE CREAM 0.1%W/W Betamethasone Valerate (1mg/1g) 1 WHAT IS IN THIS LEAFLET 1. What Zontron Betasone Cream 0.1%w/w is used for 2. How Zontron Betasone Cream 0.1%w/w works 3. Before you use Zontron Betasone Cream 0.1%w/w 4. How to use Zontron Betasone Cream 0.1%w/w 5. While you are using it 6. Side effects 7. Storage and Disposal of Zontron Betasone Cream 0.1%w/w 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT ZONTRON BETASONE CREAM 0.1%W/W IS USED FOR Zontron Betasone Cream 0.1%w/w is used for inflammatory condition responding to corticosteroid therapy. HOW ZONTRON BETASONE CREAM 0.1%W/W WORKS Zontron Betasone Cream 0.1%w/w contains a medicine called betamethasone valerate. It belongs to a group of medicine called corticosteroids that reduces swelling and itchiness. BEFORE YOU USE ZONTRON BETASONE CREAM 0.1%W/W _- When you must not use it _ Do not apply Zontron Betasone Cream 0.1%w/w if: You are allergic (hypersensitive) to betamethasone or to any of the other ingredients in this medicine. Do not use Zontron Betasone cream 0.1%w/w for the following condition: Untreated skin infections Face redness Acne Itchiness without inflammation Itchiness around the anus and genital rashes around your mouth skin conditions in infants under one year of age, including inflammation. _ _ _ _ _ _ _ _ _- Before you start to use it _ Pregnancy and breast feeding: Ask your doctor or pharmacist for advice before applying this medicine if you are pregnant or breastfeeding. It is not known whether betamethasone is found in breast milk or whether it has a harmful effect in the newborn. ·If used during breastfeeding, do not apply betamethasone valerate to the breasts to avoid accidental ingestion by the baby. Inform your doctor or pharmacist if you: have history of allergic reaction to corticosteroids have psoriasis _- Taking other medicines _ Tell your doctor or pharmaci Прочитайте повний документ
PRODUCT LITERATURE ZONTRON BETASONE CREAM 0.1%W/W EACH G CONTAINS Betamethasone 17-Valerate 1.215 mg equivalent to Betamethasone 1 mg PRESERVATIVE Methyl Paraben 0.1% w/w DESCRIPTION Odourless, white soft cream PHARMACODYNAMICS PROPERTIES 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 PROPERTIES 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. Distribution The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary because 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. INDICATION Indicated for inflammatory condition responding to steroid therapy RECOMMENDED DOSAGE Apply a thin layer on the affected part 2 to 3 times a day until complete resolution of lesions. ROUTE OF ADMINISTRATION Topical CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed. The following conditions should not be treated Прочитайте повний документ