CUTIVATE CREAM 0.05% WW

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

FLUTICASONE PROPIONATE

Mevcut itibaren:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Adı):

FLUTICASONE PROPIONATE

Paketteki üniteler:

15gm1Units Units; 100gmUnits Units

Tarafından üretildi:

GLAXO WELLCOME OPERATIONS UK LTD

Bilgilendirme broşürü

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
CUTIVATE CREAM
_ _
Fluticasone propionate (0.05% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Cutivate is used for
2.
How Cutivate works
3.
Before you use Cutivate
4.
How to use Cutivate
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Cutivate
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CUTIVATE IS USED FOR
The name of this medicine is
Cutivate Cream. Cutivate is used
to reduce the risk of chronic
atopic eczema from coming
back once an acute episode has
been treated effectively.
Cutivate relieves the
inflammatory and itching
manifestations of corticosteroid-
responsive skin problems. These
include:
•
eczema
•
chronic itchy skin such as
prurigo, neurodermatoses
including lichen simplex
and lichen planus
•
seborrhoeic dermatitis (a
red, scaly, itchy and
stubborn dandruff that
mainly affect the scalp)
•
discoid lupus
erythematosus (recurring
scaly rash)
•
used in addition to oral or
injectable steroids for
generalised erythroderma
(widespread redness and
scaling of the skin due to
imflammatory skin disease)
•
contact sensitivity reactions
•
prickly heat
•
insect bite reactions
•
psoriasis (thickened rough
patches of inflamed red
skin, often covered by fine
silvery scales)
For babies above three months
and children Cutivate is used for
skin inflammation that has not
responded to milder steroid
creams or ointments.
HOW CUTIVATE WORKS
Cutivate contains fluticasone
propionate
_ _
which belong to a
group of medicines called
steroids. Steroids help to reduce
redness, swelling and irritation
of the skin.
BEFORE YOU USE CUTIVATE
-
_When you must not use it _
Do not use Cutivate to treat any
of the following skin problems,
it could make them worse:
•
infected skin (unless the
infection is being treated
with an anti-infective
medicine at the same time)
•
acne
•
rosacea (a facial skin
condition where the nose,
cheeks, chin, forehead or
entire face are unusually red
•
rashe

Ürün özellikleri

CONFIDENTIAL
[GSK logo]
CUTIVATE
FLUTICASONE PROPIONATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of
_CUTIVATE_
Cream 0.05% w/w contains 500 micrograms of fluticasone
propionate (micronised). It also contains Imidurea 0.2%w/w as a
preservative.
CLINICAL INFORMATION
INDICATIONS
TREATMENT OF INFLAMMATORY DERMATOSES
_CUTIVATE_
Cream is indicated for adults and children aged 1 year and over for
the relief of
the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses such
as:
−
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
−
Prickly heat
_CUTIVATE_
Cream is indicated for children aged 3 months to less than 1 year for
the relief
of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses
such as:
CONFIDENTIAL
−
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
The safety and efficacy of drug use for longer than 4 weeks in this
population have not
been established. The safety and efficacy of
_CUTIVATE_
Cream in paediatric patients below
3 months of age have not been established.
REDUCTION OF RISK OF RELAPSE
_CUTIVATE_
Cream is indicated for the reduction of the risk of relapse of chronic
recurrent
atopic eczema once an acute episode has been treated effectively.
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Cream
ADULTS, ELDERLY, CHILDREN AND INFANTS AGED 3 MONTHS AND OVER
Creams are especially appropriate for moist