Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
BETAMETHASONE
15gm mcg/mL; 100gm mcg/mL
GLAXO WELLCOME OPERATIONS
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ BETNOVATE CREAM Betamethasone valerate 0.1% 1 WHAT IS IN THIS LEAFLET 1. What Betnovate is used for 2. How Betnovate works 3. Before you use Betnovate 4. How to use Betnovate 5. While you are using it 6. Side Effects 7. Storage and Disposal of Betnovate 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT BETNOVATE IS USED FOR Betnovate relieves the inflammatory and itching skin problems which are responsive to steroid including: eczema, psoriasis, dandruff, allergic reactions, insect bites, prickly heat and other conditions. For children over the age of one year Betnovate is used for skin condition that has not responded to milder steroid creams or ointments. HOW BETNOVATE WORKS Betnovate belongs to a group of medicines called steroids. Steroids help to reduce redness, swelling and irritation of the skin. BEFORE YOU USE BETNOVATE - _When you must not use it _ Do not use Betnovate 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 • face redness • rashes around the mouth • itchy skin which is not inflamed • itchiness around the anus or genitals (penis and vagina) • on children under 1 year If you think any of these apply to you, do not use Betnovate until you have checked with your doctor or pharmacist. - _Before you start to use it _ If you are pregnant, or think you could be, or if you are planning to become pregnant, do not use Betnovate without talking to your doctor first. If you are breast-feeding, you must check with your doctor before you use Betnovate. If you do use Betnovate when breast-feeding, do not use Betnovate on your breast area to ensure that the baby does not accidentally get Betnovate in their mouth. _ _ - _Taking other medicines _ Some medicines may affect how Betnovate works or make it more likely that you will have side effects. Examples of these Baca dokumen lengkap
CONFIDENTIAL [GSK logo] BETNOVATE Betamethasone 17-valerate QUALITATIVE AND QUANTITATIVE COMPOSITION Betnovate Cream is a smooth white cream containing 0.1% w/w betamethasone 17- valerate in a water miscible cream based. Betnovate Cream also contains chlorocresol 0.1% w/w as preservative. CLINICAL INFORMATION INDICATIONS _BETNOVATE _ is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. These include the following: - Atopic dermatitis (including infantile atopic dermatitis) - Nummular dermatitis (discoid eczema) - Prurigo nodularis. - Psoriasis (excluding widespread plaque psoriasis) - Lichen simplex chronicus (neurodermatitis) and lichen planus - Seborrhoeic dermatitis. - Irritant or allergic contact dermatitis - Discoid lupus erythematosus - Adjunct to systemic steroid therapy in generalised erythroderma - Insect bite reactions - Miliaria (prickly heat) DOSAGE AND ADMINISTRATION PHARMACEUTICAL FORM Cream ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR Creams are especially appropriate for moist or weeping surfaces. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice daily for up to 4 weeks until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient. CONFIDENTIAL In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of _BETNOVATE_ can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions; thereafter, improvement can usually be maintained by regular application without occlusion. If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated. ATOPIC DERMATITIS (ECZEMA) Therapy wi Baca dokumen lengkap