Beta Scalp Application

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Betamethasone valerate 0.127% equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency; Betamethasone valerate 0.127%{relative} equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency

Mevcut itibaren:

Viatris Limited

INN (International Adı):

Betamethasone valerate 0.127% (=Betamethasone 0.105%. Plus 5% overage to ensure potency)

Doz:

0.1 %

Farmasötik formu:

Scalp lotion

Kompozisyon:

Active: Betamethasone valerate 0.127% equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency Excipient: Carbomer Isopropyl alcohol Purified water Sodium hydroxide Active: Betamethasone valerate 0.127%{relative} equivalent to Betamethasone 0.105%. Plus 5% overage to ensure potency Excipient: Carbomer Isopropyl alcohol Purified water Sodium hydroxide

Paketteki üniteler:

Bottle, plastic, 1x100ml, 100 mL

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Sicor (Societa Italiana Corticosteroidi) Srl

Ürün özeti:

Package - Contents - Shelf Life: Bottle, plastic, - 100 mL - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 250 mL - 24 months from date of manufacture stored at or below 25°C

Yetkilendirme tarihi:

1986-01-22

Bilgilendirme broşürü

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BETA SCALP APPLICATION
_BETAMETHASONE VALERATE SCALP LOTION 0.1% W/W_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using BETA SCALP
APPLICATION.
This leaflet answers some common
questions about BETA SCALP
APPLICATION.
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 taking BETA
SCALP APPLICATION 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 SCALP
APPLICATION IS
USED FOR
BETA SCALP APPLICATION is
used to treat conditions of the
scalp, such as psoriasis and the
inflammation associated with
severe dandruff.
BETA SCALP APPLICATION
contains the active ingredient
betamethasone valerate. It belongs
to a group of medicines called
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).
Your doctor may have prescribed
it for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
There is no evidence that BETA
SCALP APPLICATION is
addictive.
BEFORE YOU USE
BETA SCALP
APPLICATION
_WHEN YOU MUST NOT USE _
_IT_
DO NOT USE BETA SCALP
APPLICATION IF YOU HAVE AN
ALLERGY TO:

any medicine containing
betamethasone valerate

any of the ingredients listed
at the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing
or difficulty breathing; swelling
of the face, lips, tongue or other
parts of the body; rash, itching
or hives on

Ürün özellikleri

Page 1 of 7
NEW ZEALAND DATA SHEET
BETA SCALP APPLICATION
1. PRODUCT NAME
Beta Scalp Application, 0.1% w/w, scalp lotion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Beta Scalp Application contains 0.1% w/w betamethasone as the valerate
ester.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Beta Scalp Application is a transparent, slightly gelled solution
containing 0.1% w/w betamethasone
as the valerate ester.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Steroid-responsive
dermatoses
of
the
scalp,
such
as
psoriasis,
seborrhoea
capitis
and
the
inflammation associated with severe dandruff.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
A small quantity of Beta 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.
_SPECIAL POPULATIONS_
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 beneficial effect.
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
Page 2 of 7
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 (where 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 t