Beta

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

即購入

ダウンロード 製品の特徴 (SPC)
18-04-2023

有効成分:

Betamethasone valerate 0.1215%{relative} equivalent to betamethasone 0.1% w/w; Betamethasone valerate 0.1216%{relative} equivalent to betamethasone 0.1% w/w

から入手可能:

Viatris Limited

INN(国際名):

Betamethasone valerate 0.1215% w/w (equivalent to betamethasone 0.1% w/w)

投薬量:

0.1% w/w

医薬品形態:

Topical cream

構図:

Active: Betamethasone valerate 0.1215%{relative} equivalent to betamethasone 0.1% w/w Excipient: Ceteareth-20 Cetostearyl alcohol Chlorocresol Liquid paraffin Monobasic sodium phosphate dihydrate Purified water Sodium hydroxide White soft paraffin Active: Betamethasone valerate 0.1216%{relative} equivalent to betamethasone 0.1% w/w Excipient: Ceteareth-20 Cetostearyl alcohol Chlorocresol Liquid paraffin Monobasic sodium phosphate dihydrate Purified water Sodium hydroxide White soft paraffin

パッケージ内のユニット:

Tube, aluminium, 50g,

クラス:

Prescription

処方タイプ:

Prescription

製:

Sicor (Societa Italiana Corticosteroidi) Srl

適応症:

BETA preparations are indicated for the treatment of: eczema, including atopic, infantile and discoid eczemas, prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses, including lichen simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus; insect bite reactions; prickly heat; and they may be used as an adjunct to systemic steroid therapy in generalised erythroderma.

製品概要:

Package - Contents - Shelf Life: Tube, aluminium, - 30 g - 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 50 g - 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 100 g - 24 months from date of manufacture stored at or below 25°C

承認日:

2003-05-30

情報リーフレット

                                Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BETA
_BETAMETHASONE VALERATE 0.1% W/W CREAM AND OINTMENT _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using BETA
Cream or Ointment.
This leaflet answers some common
questions about BETA Cream and
Ointment.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using BETA Cream
or Ointment against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BETA CREAM
OR OINTMENT IS USED
FOR
Your BETA Cream or Ointment
contains the active ingredient
betamethasone valerate. It belongs to
a group of medicines known as topical
corticosteroids. “Topical” means that
they are applied onto the skin. Topical
corticosteroids are used to help
reduce the inflammation that causes
the redness and itchiness in a variety
of conditions (they are not ‘anabolic’
steroids which are sometimes
misused by athletes).
BETA Cream or Ointment is useful
in treating various inflamed
conditions of the skin such as:

psoriasis

severe forms of eczema

lichen planus (chronic itchy
skin of unknown origin)

discoid lupus
erythematosus (recurring
scaly rash)

prickly heat skin reaction

insect bite reactions

prurigo nodularis (an itching
and thickening of the skin
with lumps or nodules)

contact sensitivity reactions

an additional treatment for
an intense widespread
reddening and inflammation
of the skin
when milder topical corticosteroids
cannot treat the skin condition
effectively.
BETA Cream is usually used to treat
skin conditions on moist surfaces;
BETA Ointment is usually used to
treat skin conditions on dry, scaly
skin.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have pre
                                
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製品の特徴

                                Page 1 of 8
NEW ZEALAND DATA SHEET
BETA
1. PRODUCT NAME
Beta, 0.1%w/w, cream.
Beta, 0.1%w/w, ointment.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 g of cream contains 0.1% w.w of Betamethasone valerate cream.
Each 1 g of ointment contains 0.1% w.w of Betamethasone valerate
ointment.
Excipients with known effect include:
Beta cream: Cetostearyl alcohol, Chlorocresol.
Beta ointment: Propylene glycol
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
BETA cream: A white, soft, homogeneous cream containing 0.1% w/w
betamethasone as the
valerate ester.
BETA ointment: A soft, smooth, translucent ointment containing 0.1%
w/w betamethasone as the
valerate ester.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
BETA preparations are indicated for the treatment of:

eczema, including atopic, infantile and discoid eczemas;

prurigo nodularis;

psoriasis (excluding widespread plaque psoriasis);

neurodermatoses, including lichen simplex, lichen planus;

seborrhoeic dermatitis;

contact sensitivity reactions;

discoid lupus erythematosus;

insect bite reactions;

prickly heat;
and they may be used as an adjunct to systemic steroid therapy in
generalised erythroderma.
Page 2 of 8
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR_
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice daily
for up to 4 weeks until improvement occurs, then reduce the frequency
of the application or change
the treatment to a less potent preparation. Allow adequate time for
absorption after each application
before applying an emollient.
BETA cream is especially appropriate for moist or weeping surfaces and
BETA ointment for dry,
lichenified or scaly lesions, but this is not invariably so.
In the more resistant lesions, such as the thickened plaques of
psoriasis on the elbows and knees,
the effect of BETA can be enhanced, if necessary, by occluding the
treatment area with polythene
film. Overnight occlusio
                                
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