Land: Indonesien
Sprache: Indonesisch
Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FLUPREDNIDENE ACETATE, GENTAMICIN SULFATE
MERCK TBK - Indonesia
FLUPREDNIDENE ACETATE, GENTAMICIN SULFATE
1 MG
KRIM
DUS, 1 TUBE @ 10 G
MEPROFARM - Indonesia
2021-03-28
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 Lesen Sie das vollständige Dokument