Eumovate

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

유효 성분:

Clobetasone butyrate 0.05%{relative};  

제공처:

GlaxoSmithKline NZ Limited

INN (International Name):

Clobetasone butyrate 0.05% w/w

복용량:

0.05% w/w

약제 형태:

Topical cream

구성:

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

패키지 단위:

Tube, aluminium, sample, 5 g

수업:

Prescription

처방전 유형:

Prescription

Manufactured by:

Glaxo Operations UK Ltd

치료 징후:

Treatment of atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, prurigo nodularis, sevorrhoeic dermatitis, and other steroid responsive skin conditions which do not require the use of a more active topical corticosteroid in children and adults. In the more resistant dermatoses. Eumovate may be used as maintenance therapy between courses of one of the more active topical steroids.

제품 요약:

Package - Contents - Shelf Life: Tube, aluminium, sample - 5 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 - Tube, aluminium, - 100 g - 36 months from date of manufacture stored at or below 25°C

승인 날짜:

1976-04-14

환자 정보 전단

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

제품 특성 요약

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