Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BETAMETHASONE
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
BETAMETHASONE
15gm mcg/mL
XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD
_CONSUMER MEDICAL INFORMATION LEAFLET (RIMUP) _ ___________________________________________________________________________________________________________________________ _ ____________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET: 1. What is Uniflex Cream used for 2. How Uniflex Cream works 3. Before you use Uniflex Cream 4. How to use Uniflex Cream 5. While you are using Uniflex Cream 6. Side Effects 7. Storage and Disposal of Uniflex Cream 8. Product Description 9. Manufacturer and Registration Holder 10. Date of Revision WHAT IS UNIFLEX CREAM USED FOR To be applied on the skin. For the relief of: • inflammatory manifestations of corticosteroid responsive skin diseases such as in eczema, dermatitis, some form of psoriasis and intertrigo. HOW UNIFLEX CREAM WORKS Betamethasone is a potent corticosteroid that helps to reduce inflammation and itchiness. BEFORE YOU USE UNIFLEX CREAM _-When you must not to use it_ • Do not use this medicine if you are allergic to Betamethasone or any other ingredients in this medicine. • Not to be use on mouth areas and around eye, anal and genital where skin is thinner. • If irritation develops with the use of Uniflex, treatment should be discontinued. • Topical steroids should not be used in large amounts or for prolonged periods in pregnant women. • Avoid prolonged use or over large areas of the body particularly with occlusive dressing present. • Do not use on the face, broken or infected skin, including cold sores, acne and athletes’ foot and chicken pox. • Do not use in your children under 1 year old. _-Before you start to use it_ Tell your doctor or pharmacist if you: • are pregnant or breast-feeding. • have viral, fungal or bacterial skin infection. _-Taking other medicines_ Tell your doctor or pharmacist if you are taking or having recently taken any other medicines. This includes any medicines which you have bought without a prescription especially barbiturates (used for depressants Przeczytaj cały dokument
UN0102/UN0401/UN0501-001 10.20 Important information. Please read carefully. Uniflex TM Cream 0.1%, 0.05% and 0.025% COMPOSITION UNIFLEX CREAM 0.1% Contains Betamethasone 17-valerate equivalent to Betamethasone 0.1% w/w in a non-greasy water miscible cream. Chlorocresol 0. 15 % w/w as preservative. UNIFLEX CREAM 0.05% Contains Betamethasone 17-valerate equivalent to Betamethasone 0.05% w/w in a non-greasy water miscible cream. Chlorocresol 0. 15 % w/w as preservative. UNIFLEX CREAM 0.025% Contains Betamethasone 17-valerate equivalent to Betamethasone 0.025% w/w in a non-greasy water miscible cream. Chlorocresol 0. 15 % w/w as preservative. PHARMACODYNAMICS Betamethasone 17-valerate is a potent synthetic corticosteroid with anti-inflammatory and antipruritic actions. Betamethasone is a synthetic glucocorticoid whose principal actions are gluconeogenesis, glycogen deposition, protein and calcium metabolism, inhibition of corticotrophin secretion and anti-inflammatory activity. Its effectiveness in topical applications is primarily due to its anti-inflammatory and antipruritic actions. PHARMACOKINETICS Betamethasone is absorbed through the skin, particularly in denuded areas. Its penetration through the skin can be increased by means of an occlusive dressing. The absorbed betamethasone is metabolized in the liver and excreted in the urine. INDICATIONS For the relief of inflammatory manifestations of corticosteroid-responsive dermatoses such as in eczema, infantile eczema, atopic dermatitis, dermatitis herpetiformis, contact dermatitis, seborrhoeic dermatitis, neurodermatitis, some form of psoriasis and intertrigo. DOSAGE AND ADMINISTRATION For external use only. Apply sparingly onto the affected area 2 to 3 times a day. When a favourable response is obtained, reduce application gradually and eventually discontinue. CONTRAINDICATIONS Unless under medical supervision, UNIFLEX should not be used for rosacea or on areas around the mouth. UNIFLEX should not be used for acne, viral skin infections e.g. herpes simplex (col Przeczytaj cały dokument