Riik: Lõuna-Aafrika Vabariik
keel: inglise
Allikas: South African Health Products Regulatory Authority (SAHPRA)
Adcock
ADCO-BETAMETHASONE CREAM SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): ADCO-BETAMETHASONE CREAM COMPOSITION : Each 5 g contains 6 mg betamethasone valerate equivalent to 5 mg betamethasone. Preservatives: Methyl hydroxybenzoate 0,2% m/m Propyl hydroxybenzoate 0,02% m/m PHARMACOLOGICAL CLASSIFICATION: A. 13.4.1Corticosteroids with or without anti-infective agents. PHARMACOLOGICAL ACTION: Betamethasone valerate is a potent topical corticosteroid which exhibits anti-inflammatory and anti-allergic properties when applied to the skin and mucosa. The mechanism of action is related to causing vasoconstriction, stabilising lysosomal membranes, suppressing cell division and suppressing the immune response. INDICATIONS: Non-infected steroid responsive dermatoses. CONTRA-INDICATIONS: Hypersensitivity to any of the ingredients. Rosacea, acne, peri-oral dermatitis, tuberculosis of the skin and varicose ulcers. Skin lesions caused by infection with viruses (e.g. herpes simplex) vaccinia or varicella), Fungi (e.g. candidiasis, tinea) or bacteria (e.g. impetigo). ADCO-BETAMETHASONE must not be used in the nappy areas of infants for flexural eruptions. Betamethasone valerate should not be used in acute infections. Corticosteroids have shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity following topical application cannot be excluded. Therefore ADCO-BETAMETHASONE must not be used during pregnancy. Betamethasone should not be used to treat infections and ulcers of the leg. It causes delayed wound healing and increased liability to infections. WARNING: For external use only. DOSAGE AND DIRECTIONS FOR USE: Apply to the affected areas 1 to 3 times daily by gentle inunction. SIDE EFFECTS AND SPECIAL PRECAUTIONS: Local effects include subcu Lugege kogu dokumenti