CUTIVATE

البلد: أندونيسيا

اللغة: الإندونيسية

المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

العنصر النشط:

FLUTICASONE PROPIONAT

متاح من:

GLAXO WELLCOME INDONESIA - Indonesia

INN (الاسم الدولي):

FLUTICASONE PROPIONAT

جرعة:

0,05%

الشكل الصيدلاني:

KRIM

الوحدات في الحزمة:

DUS, 1 TUBE @ 10 GRAM

المصنعة من قبل:

GLAXO WELLCOME INDONESIA - Indonesia

تاريخ الترخيص:

2017-11-24

خصائص المنتج

Page 1 of 6
CUTIVATE
TM
FLUTICASONE PROPIONATE
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluticasone propionate (micronised) 0.05% w/w (500 micrograms/g).
2. PHARMACEUTICAL FORM
Cream.
3. CLINICAL PARTICULARS
3.1 INDICATIONS
_CUTIVATE_ Cream is indicated 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); Neudermatoses
including Lichen simplex; Lichen planus, Seborrhoeic dermatitis;
Contact sensitifity reactions;
Discoid
lupus
erythematosus;
An
adjunct
to
systemic
steroid
therapy
in
generalised
erythroderma; Insect bites reactions, Prickly heat.
3.2 DOSAGE AND ADMINISTRATION
For eczema/dermatitis, apply a thin of _CUTIVATE_ Cream to the
affected skin areas once daily.
For all other indications, apply a thin film of _CUTIVATE_ Cream to
the affected skin areas twice
daily. Calculation of the appropriate dosage for children should allow
for their greater surface area
to body weight ratio.
3.3. CONTRAINDICATIONS
The following conditions should not be treated with _CUTIVATE_ Cream:

Untreated cutaneous infections

Rosacea_ _

Acne vulgaris

Perioral dermatitis

Primary cutanoeous viral infection

Hypersensitivity to corticosteroids or other materials contained in
_CUTIVATE_ cream

Perianal and genital pruritus

Primary infected skin lesion

Pruritus without inflammation

Dermatoses in children under one year of age, including dermatitis and
napkin eruptions
3.4 WARNINGS AND PRECAUTIONS
_CUTIVATE_ Cream should be used with caution in patients with a
history of local hypersensitivity
to corticosteroids or to any of the excipients in the preparation.
Local hypersensitivity reactions
(_see Adverse Reactions_) may resemble symptoms of the condition under
treatment.
Manifestations of hypercortisolism (Cushing’s Syndrome) and
reversible hypothalamic-pituitary-
adrenal (HPA) axis suppression, leading to a gluc