BETNOVATE OINTMENT

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:

OINTMENT

تركيب:

BETAMETHASONE AS VALERATE 0.1 %W/W

طريقة التعاطي:

DERMAL

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GLAXO OPERATIONS (UK) LIMITED

المجموعة العلاجية:

BETAMETHASONE

المجال العلاجي:

BETAMETHASONE

الخصائص العلاجية:

Betamethasone valerate is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.These include the following:Atopic dermatitis (including infantile atopic dermatitis)Nummular dermatitis (discoid eczema)Prurigo nodularisPsoriasis (excluding widespread plaque psoriasis)Lichen simplex chronicus (neurodermatitis) and lichen planusSeborrhoeic dermatitisIrritant or allergic contact dermatitisDiscoid lupus erythematosusAdjunct to systemic steroid therapy in generalised erythroderma

تاريخ الترخيص:

2021-05-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Betnovate Ointment
Betamethasone (as valerate) 0.1% w/w
Each 1 g contains 1 mg of betamethasone (as valerate).
For the list of the inactive and allergenic ingredients in the
medicine, see section
6 – “Additional information”.
Read the 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 the treatment of your ailment.
Do not
pass it on to others. It may harm them, even if it seems to you that
their medical
condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Betnovate contains a medicine called betamethasone valerate.
Betamethasone valerate is a potent topical steroid indicated for
adults, elderly
and children over 1 year of age for the relief of inflammatory and
pruritic
manifestations of steroid responsive dermatoses including the
following:
• Atopic dermatitis (including infantile atopic dermatitis)
• Nummular dermatitis (also called discoid eczema)
• Prurigo nodularis
• Psoriasis (excluding widespread plaque psoriasis)
• Lichen simplex chronicus (neurodermatitis) and lichen planus
• Seborrhoeic dermatitis
• Irritant or allergic contact dermatitis
• Discoid lupus erythematosus
• Adjunct to systemic steroid therapy in generalised erythroderma
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 contained in this medicine (as listed in
section 6)
∙
For treatment of any of the following skin problems, as the medicine
could make them worse:
-
acne
-
severe flushing of the skin on and around the nose (rosacea)
-
spotty red rash around the mouth
-
itching around your anus or genitals (penis or vagina)
-
skin i

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Betnovate Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone Valerate B.P. 0.122% w/w
Equivalent to 0.1 % w/w betamethasone
3
PHARMACEUTICAL FORM
Ointment
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Betamethasone valerate is a potent topical corticosteroid indicated
for adults, elderly
and children over 1 year for the relief of the inflammatory and
pruritic manifestations
of steroid responsive dermatoses. These include the following:
Atopic dermatitis (including infantile atopic dermatitis)
Nummular dermatitis (discoid eczema)
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Lichen simplex chronicus (neurodermatitis) and lichen planus
Seborrhoeic dermatitis
Irritant or allergic contact dermatitis
Discoid lupus erythematosus
Adjunct to systemic steroid therapy in generalised erythroderma
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Cutaneous
Ointments are especially appropriate for dry, lichenified or scaly
lesions.
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 application or change the treatment to a less potent
preparation.
Allow adequate time for absorption after each application before
applying an
emollient.
In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and
knees, the effect of betamethasone valerate can be enhanced, if
necessary, by
occluding the treatment area with polythene film. Overnight occlusion
only is usually
adequate to bring about a satisfactory response in such lesions;
thereafter,
improvement can usually be maintained by regular application without
occlusion.
If the condition worsens or does not improve within 2-4 weeks,
treatment and
diagnosis should be re-evaluated.
Therapy with betamethasone valerate should be gradually discontinued
once control
is achieved and an emollient continued as maintenance the