XORSONE 1:8 cream

Country: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Kauptu það núna

Vara einkenni Vara einkenni (SPC)
28-02-2023

Virkt innihaldsefni:

BETAMETHASONE VALERATE

Fáanlegur frá:

Xorix Sdn Bhd

INN (Alþjóðlegt nafn):

BETAMETHASONE VALERATE

Einingar í pakka:

15 gm

Framleitt af:

Xorix Sdn Bhd

Upplýsingar fylgiseðill

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XORSONE 1:8 CREAM
BETAMETHASONE (AS-VALERATE) 0.0125 % W/W
Page 1 of 2
WHAT IS IN THIS LEAFLET:
1.
What XORSONE 1:8 cream is
used for.
2.
How XORSONE 1:8 cream
works.
3.
Before you use XORSONE 1:8
cream
4.
How to use XORSONE 1:8
cream.
5.
While you are using it.
6.
Side E
ff
ects.
7.
Storage and disposal of use
XORSONE 1:8 cream.
8.
Product Description.
9.
Manufacturer and Product
Registration Holder.
10.
Date of Revision.
WHAT XORSONE 1:8 CREAM IS USED FOR
XORSONE 1:8 Cream is used to
alleviate itching, redness and swelling
of certain skin problems, such as
eczema, psoriasis and dermatitis. It is
used for:

milder skin problems, or


to keep your skin problem under
control after Betamethasone
Valerate 0.1%w/w cream has
improved it.

HOW XORSONE 1:8 CREAM WORKS
XORSONE 1:8 Cream contains a
medicine called Betamethasone (as 17-
valerate). It belongs to a group of
medicines called steroids. It works by
reducing the inflammation in the
affected area to reduce the redness and
itchiness of skin.
BEFORE YOU USE XORSONE 1:8 CREAM
_When you must not use it _

If you allergic to betamethasone
valerate and any of the ingredients
listed at the end of this leaflet.


On a children under 1 year.


To treat any of the following skin
problems:

-
Acne.
-
severe flushing of skin on and
around your nose (rosacea).
-
spotty red rash around your
mouth (perioral dermatitis)
-
itching around your anus or
private parts.
-
Primary infected skin lesions
caused by infection with fungi
or bacteria.
-
Primary cutaneous viral
infections e.g. herpes simplex,
chickenpox.
If you think any of these apply to you,
do not use XORSONE 1:8 Cream until
you have checked with your doctor or
pharmacist.
_Before you start to use it _
Check with your doctor or pharmacist
before using your medicine if:

If
you
have
previously
had
an
allergic
reaction
with
another
steroid.


If you are applying near eyes or on
eyelids, as cataracts or glaucoma
may result if the cream r
                                
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Vara einkenni

                                XORSONE 1:8
_XORSONE 1:8 CREAM _
_DESCRIPTION _
_XORSONE 1:8 Cream is a white, soft cream and free from foreign matter
containing _
_Betamethasone (as 17-valerate) 0.0125% w/w._
_PHARMACODYNAMICS/PHARMACOKINETICS_
_XORSONE _
_1:8 _
_cream _
_contains _
_betamethasone _
_(as _
_17-valerate), _
_an _
_active _
_corticosteroid with topical anti-inflammatory, antipruritic and
vasoconstrictive _
_properties._
_Topical corticosteroid can be absorbed through skin. Skin with
inflammation _
_and/or _
_other _
_disease _
_processes _
_in _
_the _
_skin _
_may _
_increase _
_percutaneous _
_absorption. Occlusive dressings on the skin increase percutaneous
absorption _
_and substantially increase the percutaneous absorption of
corticosteroid._
_Topical corticosteroid follow the same pharmacokinetic pathways
similar to _
_systemically administered corticosteroid. Corticosteroid are bound to
plasma _
_proteins in varying degrees and are metabolised primarily by the
liver and _
_excreted by the kidneys._
_INDICATIONS_
_Betamethasone _
_valerate _
_readily _
_diluted _
_preparations _
_are _
_indicated _
_for _
_maintenance treatment once an acute episode has been treated
effectively with _
_a continuous course of betamethasone valerate 0.1%w/w._
_• _
_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._
_• _
_An adjunct to systemic steroid therapy in generalised erythroderma._
_• _
_Insect bite reactions._
_RECOMMENDED DOSAGE_
_ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR_
_Creams are especially appropriate for moist or weeping surfaces._
_Once an acute episode has been treated effectively with a continuous
course _
_of betamethasone valerate, improvement may be maintained with a small
_
_amount of readily diluted betamethasone valerate applied once or
twice a d
                                
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