Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clobetasone butyrate; Oxytetracycline calcium; Nystatin
Ennogen Healthcare Ltd
D07CB
Clobetasone butyrate; Oxytetracycline calcium; Nystatin
500microgram/1gram ; 30mg/1gram ; 100000unit/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000; GTIN: 5000123104352
NUMBER OF FINGERTIP UNITS NEEDED CHILDS AGE FACE ARM LEG FRONT BACK AND NECK AND HAND AND FOOT INCLUDING BUTTOCKS 3-6 months 1 1 1.5 1 1.5 1-2 years 1 ½ 1 ½ 2 2 3 3-5 years 1 ½ 2 3 3 3 ½ 6-10 years 2 2 ½ 4 ½ 3 ½ 5 Trimovate Cream CLOBETASONE 17-BUTYRATE, CALCIUM OXYTETRACYCLINE AND NYSTATIN PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ! Keep this leaflet. You may need to read it again. ! If you have any further questions, ask your doctor or pharmacist. ! This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ! If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 What Trimovate is and what it is used for 2 What you need to know before you use Trimovate 3 How to use Trimovate 4 Possible side effects 5 How to store Trimovate 6 Contents of the pack and other information 1 WHAT TRIMOVATE IS AND WHAT IT IS USED FOR Trimovate contains three different active substances called clobetasone butyrate, calcium oxytetracycline and nystatin. Clobetasone butyrate belongs to a group of medicines called corticosteroids. It helps to reduce redness, swelling and irritation of the skin. Calcium oxytetracycline (an antibiotic) and nystatin (an antifungal) are medicines used to fight infections. They fight certain bacterial and fungal infections of the skin. Trimovate is used in adults, the elderly, children and infants to help reduce the redness and itchiness of certain skin problems, such as eczema, nappy rash and dermatitis where infection may be a problem. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE TRIMOVATE DO NOT USE TRIMOVATE: ! if you are allergic to clobetasone butyrate, calcium oxytetracycline or oxytetracycline, nystatin or any of the other ingredients of this medicine (listed in section 6) ! to tre Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trimovate Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Trimovate Cream is a yellow water-miscible cream containing clobetasone 17- butyrate 0.05% w/w, oxytetracycline 3.0% w/w as calcium oxytetracycline and nystatin 100,000 units per gram. Excipients with known effect: Cetostearyl alcohol Chlorocresol For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clobetasone 17-butyrate 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. Nystatin is a polyene antifungal. Oxytetracycline is a broad spectrum antibiotic. Topical preparations combining clobetasone with nystatin and oxytetracycline are indicated for the treatment and management of steroid responsive dermatoses where candidal or bacterial infection is present, suspected or likely to occur. These include the following: - Atopic dermatitis - Nappy rash - Intertrigo - Anogenital pruritis - Seborrhoeic dermatitis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS, ELDERLY, CHILDREN AND INFANTS For topical use only. 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 a day for up to seven days. If the infection worsens, treatment and diagnosis should be re-evaluated as soon as possible. If the condition does not improve within seven days, treatment and diagnosis should be re-evaluated. Treatment should not be continued for more than seven days without medical supervision. Allow adequate time for absorption after each application before applying an emollient. Patients should be advised to wash their hands after applying clobetasone with nystatin and oxytetracycline, unless it is the hands that are being treated. Rebound of pre-existing dermatoses can occur with abrupt discontinu Lees het volledige document