País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Clobetasone butyrate 0.05%{relative};
GlaxoSmithKline NZ Limited
Clobetasone butyrate 0.05% w/w
0.05% w/w
Topical cream
Active: Clobetasone butyrate 0.05%{relative} Excipient: Beeswax, synthetic Cetostearyl alcohol Chlorocresol Citric acid monohydrate Dimeticone Glycerol Glyceryl monostearate Purified water Self-emulsifying glyceryl monostearate Sodium citrate dihydrate
Tube, aluminium, 15 g
Restricted
Restricted
Glaxo Operations UK Ltd
Short-term (up to 7 days) treatment of milder forms of eczema and dermatitis.
Package - Contents - Shelf Life: Tube, aluminium, - 15 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 25°C
2006-04-21
EUMOVATE 1 EUMOVATE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING EUMOVATE? EUMOVATE contains the active ingredient clobetasone butyrate. EUMOVATE is used to treat eczema and dermatitis. For more information, see Section 1. Why am I using EUMOVATE? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE EUMOVATE? Do not use if you have ever had an allergic reaction to clobetasone butyrate, other similar medicines such as hydrocortisone or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use EUMOVATE? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with EUMOVATE and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE EUMOVATE? • Follow the instructions provided and use EUMOVATE for no more than 7 days • The minimum amount of EUMOVATE cream should be used for the minimum amount of time More instructions can be found in Section 4. How do I use EUMOVATE? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING EUMOVATE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using EUMOVATE THINGS YOU SHOULD NOT DO • Do not use EUMOVATE for more than 7 days without speaking to your doctor • Do not use EUMOVATE on children under the age of 12 unless advised by a doctor • Do not use EUMOVATE to treat any other medical conditions other than eczema and dermatitis unless advised by doctor • Do not give the cream to anyone else, even if they have similar symptoms to you DRIVING OR USING MACHINES • Be careful before you drive or use any machines or tools until you know how EUMOVATE affects you. LOOKING AFTER Y Leer el documento completo
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME EUMOVATE clobetasone 17-butyrate 0.05% w/w cream_. _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clobetasone 17-butyrate BP 0.05% w/w Excipients with known effect: cetostearyl alcohol; chlorocresol For the list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICL FORM Cream EUMOVATE cream is white in appearance. The emollient cream is water-miscible. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Short-term (up to 7 days) treatment of milder forms of eczema and dermatitis in adults and children aged 12 years and over. _4.2 _ DOSE AND METHOD OF ADMINISTRATION _ _ DOSE Adults and children 12 years and over Apply a thin film and gently rub in, using only enough to cover the affected area twice daily for up to 7 days. If the condition resolves within 7 days, treatment with EUMOVATE cream should be stopped. If the condition does not improve within the first 7 days or becomes worse, the patient should see a doctor. If after 7 days of treatment, improvement is seen but further treatment is required, the patient should see a doctor. After application, the hands should be washed unless they are the site being treated. Patients advised by their doctors to use this cream for prolonged periods should be advised to tell subsequent doctors about this use. All patients should be warned against prolonged used on one area of skin, or use of excessive quantities. Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with potent preparations. 2 All patients should also be informed that the preparation is prescribed only for a specific condition occurring in a specific individual. Children Use in children under 12 years only on the advice of a doctor. Children are more likely to develop local and systemic adverse reactions of topical corticosteroids and, in general, require shorter courses and less potent agents than adults. Care should be taken when using clobetasone to ensure the amount applied is the minimum t Leer el documento completo