Nazione: Sudafrica
Lingua: inglese
Fonte: South African Health Products Regulatory Authority (SAHPRA)
Lennon
PERSIVATE® OINTMENT PERSIVATE® CREAM SCHEDULING STATUS: S4 PROPRIETARY NAME: (and dosage form) PERSIVATE ® OINTMENT PERSIVATE ® CREAM COMPOSITION: Each 5 g ointment contains betamethasone valerate equivalent to 5 mg betamethasone. Each 5 g cream contains betamethasone valerate equivalent of 5 mg betamethasone. Persivate cream is preserved with 0,1% m/m chlorocresol. PHARMACOLOGICAL CLASSIFICATION: A 13.4.1 Corticosteroids 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, stabilizing lysosomal membranes, suppressing cell division and suppressing the immune response. INDICATIONS: Non-infected steroid responsive dermatoses. CONTRA-INDICATIONS: Betamethasone valerate is contra-indicated in the treatment of herpes simplex, vaccinia or varicella. Long, term use is contra-indicated in patients with diabetes mellitus or tuberculosis. WARNING: FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. DOSAGE AND DIRECTIONS FOR USE. Persivate ® Ointment: Apply to the affected areas 2 or 3 times daily by gentle inunction or use with occlusive dressings. Persivate ® Cream: Apply to the affected areas 2 or 3 times daily by gently inunction. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Local effects include atrophy of the epidermis and dermal collagen (causing atrophic striae), drying and thinning of the skin, loss of elasticity, dilatation of superficial blood vessels, telangiectasiae and ecchymoses. Increased fragility of cutaneous vessels may result in bruising and purpura. Rosacea-like dermatitis, perioral dermatitis, hypopigmentation and acneiform eruptions occur. These changes are particularly Leggi il documento completo