情報リーフレット
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LOCOID
®
0.1 % cream
Information
for
the
user
________________________________________________________________________________________________________________
We advise you to read this package insert, also if you have
used Locoid cream before.
The information may have changed.
WHAT IS LOCOID CREAM AND HOW DOES IT
WORK?
_Composition _
Locoid cream contains as active
ingredient 1 mg hydrocortisone
17-butyrate per gram.
The other ingredients are: cetostearyl
alcohol, cetomacrogol 1000, liquid
paraffin, white soft paraffin,
propylparahydroxybenzoate,
buthylparahydroxybenzoate, citric acid,
sodium citrate and purified water.
_What does Locoid cream look like and _
_how is it supplied ? _
Locoid cream is white and is packed in
tubes of 30 g. The tube is packed in a
yellow/grey/white box imprinted Locoid
cream.
_How does Locoid cream work? _
Locoid cream contains an adrenal cortex
hormone (corticosteroid) and quickly
decreases symptoms, such as itching,
redness or scaling of the skin, which
occur in certain skin disorders.
Corticosteroids in general do not cure the
underlying disease. The cream base
provides for the skin disorder to become
less moist.
_Authorization holder and manufacturer _
Locoid cream has been registered in the
name of and is manufactured by
Astellas Pharma Europe B.V.
Leiden, The Netherlands.
Locoid cream is only available on
prescription.
WHAT CAN LOCOID CREAM BE USED FOR?
Locoid cream may be used for the
treatment of superficial skin diseases in
which itching, redness or scaling are often
present. Locoid cream contains little fat
and is therefore suitable for those skin disorders
in which the skin is red and wet.
WHAT YOU SHOULD KNOW BEFORE USING
LOCOID CREAM
_When should you not use Locoid cream? _
Locoid cream should not be used for:
-
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製品の特徴
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Locoid
®
ointment 0.1%
Locoid Lipocream
®
, cream 0.1%
Locoid
®
cream 0.1%
Locoid Crelo
®
, cutaneous emulsion 0.1%
Locoid
®
scalp lotion 0.1%
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Locoid ointment and cream, Locoid Lipocream and Locoid Crelo
contain 1 mg/g and Locoid lotion
1mg/ml hydrocortisone 17-butyrate.
The ointment base is hydrophobic (fat); Locoid cream, Locoid
Lipocream and Locoid Crelo contain
buffered oil-in-water emulsions (Locoid Lipocream contains more fat,
Locoid cream and Locoid
Crelo more water). The lotion is buffered, somewhat viscous and
based on isopropanol-water.
3. PHARMACEUTICAL FORM
Ointment, cream, cutaneous emulsion and cutaneous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Superficial, corticosteroid responsive dermatoses, which are not
caused by micro-organisms.
Follow-up or maintenance treatment of dermatoses which have
been suppressed previously by a
stronger corticosteroid.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply 1-3 times daily a small amount of Locoid to the skin.
After improvement of the disorder, application once daily or two
to three times a week is usually
adequate.
Do not use more than 30-60 g per week in general.
Locoid should be applied evenly in a thin layer onto the diseased
skin.
To promote penetration it may be lightly massaged into the skin.
Occlusion may be necessary to obtain a better therapeutic result.
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4.3 CONTRAINDICATIONS
- Skin lesions caused by:
o
bacterial infections (e.g. pyodermias, luetic
and tuberculous processes)
o
viral infections (e.g. varicellae, herpes simplex, herpes zoster,
verrucae vulgares, verrucae
planae, condylomata, mollusca contagiosa)
o
mycotic and yeast infections
o
parasitic infections (e.g. scabies)
- Ulcerous skin lesions, wounds
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