GENTACORTIN

Country: Indónesía

Tungumál: indónesíska

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

Virkt innihaldsefni:

FLUPREDNIDENE ACETATE; GENTAMICIN SULFATE

Fáanlegur frá:

MERCK TBK - Indonesia

INN (Alþjóðlegt nafn):

FLUPREDNIDENE ACETATE; GENTAMICIN SULFATE

Skammtar:

0,1 %

Lyfjaform:

KRIM

Einingar í pakka:

DUS, 1 TUBE @ 10 G

Framleitt af:

MERCK TBK - Indonesia

Leyfisdagur:

2017-11-24

Vara einkenni

1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Gentacortin cream contains Fluprednidene-21-acetate 0.1% and
Gentamicin
sulfate equivalent to Gentamicin 0.1% in a well-tolerated special
cream base.
2. PHARMACEUTICAL FORM
Cream.
3. CLINICAL PARTICULARS
3.1 INDICATIONS
Gentacortin is indicate in the following skin diseases, particularly
where
bacterial infections are present or suspected:
• Eczema vulgaris (dermatitis) of all aetiology, phases and forms;
• Dyshidrotic eczema; Seborrhoic dermatitis;
• Lichen planus;
• Atopic dermatitis (endogenous eczema, neurodermatitis
disseminata);
• Insect bites and stings;
• Dermatitis solaris (sunburn);
• Small first and second degree burns and chemical burns; and
especially
under occlusive dressing,
• Psoriasis vulgaris and
• Lichen simplex chronicus (neurodermatitis circumscripta).
TOLERANCE
Gentacortin is exceptionally well tolerated.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
Gentacortin cream should be applied gently to the lesion 3 or 4 times
daily.
The area treated may be covered with a gauze dressing if desired. In
impetigo
contagiosa, the crusts should be removed before application of
gentamicin
to permit maximum contact between the antibiotics and infection.
DURATION OF ADMINISTRATION
Gentacortin cream should be applied to the affected parts of the skin
for as
there is a bacterial finding.
3.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
The following conditions should not be treated with
Fluprednidene-21-acetate:
• Unresolved cutaneous viral, bacterial or fungal infections
• Rosacea
• Acne vulgaris
• Pruritus without inflammation
• Perianal and genital pruritus
• Perioral dermatitis
• Widespread plaque psoriasis, except single lesions
• Varicella
• Cases of smallpox
• Vaccination reaction
• Skin tuberculosis and syphilis
3.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Gentacortin should be used with caution in patients with a history of
local
hypersensitivity to corticosteroids or to