BETNOVATE SCALP APPLICATION

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BETAMETHASONE AS VALERATE

متاح من:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC رمز:

D07AC01

الشكل الصيدلاني:

SOLUTION

تركيب:

BETAMETHASONE AS VALERATE 0.1 %W/W

طريقة التعاطي:

TOPICAL- SCALP

نوع الوصفة الطبية :

Required

المصنعة من قبل:

ASPEN BAD OLDESLOE GMBH, GERMANY

المجموعة العلاجية:

BETAMETHASONE

المجال العلاجي:

BETAMETHASONE

الخصائص العلاجية:

Steroid responsive dermatoses of the scalp, such as psoriasis, seborrheic capitis and inflammation associated with severe dandruff.

تاريخ الترخيص:

2021-02-28

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
BETNOVATE SCALP APPLICATION
BETAMETHASONE VALERATE 0.1% W/W
Each 10 ml contains 0.01 ml of betamethasone valerate
The list of the additional ingredients is detailed in section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
The medicine is not intended for children under 1 year of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
BETNOVATE Scalp Application (called ’Betnovate’ in this leaflet)
contains a
medicine called betamethasone valerate.
BETNOVATE is used to help reduce the redness and itchiness of certain
scalp
problems, such as psoriasis and dermatitis associated with dandruff.
THERAPEUTIC GROUP: Corticosteroids.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
•
if you are sensitive (allergic) to betamethasone valerate or to any of
the
additional ingredients of Betnovate (as listed in Section 6)
•
if you have a skin infection on your scalp (viral, bacterial and
fungal)
•
on children under 1 year of age.
Do not use Betnovate if any of the above apply to you. If you are not
sure,
talk to your physician or pharmacist before using Betnovate.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
Talk to your physician or pharmacist before you use this medicine if:
•
you have previously had an allergic reaction to another steroid.
•
you are applying the solution under an airtight dressing. These types
of
dressings make the absorption of the active ingredient through the
skin
easier and it is possible to accidentally end up using too high a
dosage of
the solution.
•
you have psoriasis; your physician will want to see you more often.
•
you

خصائص المنتج

BETNOVATE SCALP APPLICATION
PRODUCT SUMMARY
1.
TRADE NAME OF THE MEDICINAL PRODUCT
BETNOVATE SCALP APPLICATION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone Valerate BP 0.122%
w
/
w.
Equivalent to 0.11% w/w betamethasone
3.
PHARMACEUTICAL FORM
Aqueous Suspension.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Steroid responsive dermatoses of the scalp, such as psoriasis
seborrhoeic capitis
and inflammation associated with severe dandruff.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
A small quantity of Betnovate Scalp Application should be applied to
the scalp
night and morning until improvement is noticeable. It may then be
possible to
sustain improvement by applying once a day, or less frequently.
For topical application.
This product is flammable. Keep the liquid away from open fire and
flames and
all sources of ignition including smoking during application and
immediately after
use.
PAEDIATRIC POPULATION
Betamethasone valerate is contraindicated in children under one year
of age.
Children are more likely to develop local and systemic side effects of
topical
corticosteroids and, in general, require shorter courses and less
potent agents than
adults; therefore, courses should be limited to five days and
occlusion should not
be used.
Care should be taken when using betamethasone valerate to ensure the
amount
applied is the minimum that provides therapeutic benefit.
ELDERLY
Clinical studies have not identified differences in responses between
the elderly
and younger patients. The greater frequency of decreased hepatic or
renal function
in the elderly may delay elimination if systemic absorption occurs.
Therefore the
minimum quantity should be used for the shortest duration to achieve
the desired
clinical benefit.
RENAL / HEPATIC IMPAIRMENT
In case of systemic absorption (when application is over a large
surface area for a
prolonged period) metabolism and elimination may be delayed therefore
increasing the risk of systemic toxicity. Therefore the minimum
quantity should
be used for the shortest durati