Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
KENALOG IN ORABASE SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): KENALOG IN ORABASE PASTE COMPOSITION: KENALOG IN ORABASE contains 1,0 mg triamcinolone acetonide per gram. PHARMACOLOGICAL CLASSIFICATION: Category A 13.4.1 Corticosteroids with or without anti-infective agents. PHARMACOLOGICAL ACTION: Triamcinolone acetonide is a glucocorticoid and has anti-inflammatory and antipruritic actions. INDICATIONS: Treatment of steroid responsive disorders of the oral mucosa, including inflammatory and ulcerative lesions. CONTRA-INDICATIONS: Patients with a history of hypersensitivity to any of its components. Tuberculosis and viral lesions, including herpes simplex, vaccinia and varicella. KENALOG IN ORABASE is not intended for ophthalmic use, nor should it be applied in the external auditory canal of patients with perforated eardrums. Corticosteroids have been shown to be teratogenic in animals following dermal application. As these agents are absorbed percutaneously, teratogenicity, following topical application cannot be excluded. Therefore KENALOG IN ORABASE should not be used during pregnancy. WARNINGS: If significant regeneration or repair of oral tissue has not occurred in seven days, reassessment into the etiology of the oral lesion is advised. DOSAGE AND DIRECTIONS FOR USE: Coat the lesion with a thin film, preferably at bedtime. Do not rub in. It may be necessary to apply the preparation 2 or 3 times a day, preferably after meals. SIDE EFFECTS AND SPECIAL PRECAUTIONS: Prolonged and intensive treatment may cause atrophic changes in the skin, such loss of elasticity, thinning, dilation of superficial blood vessels, telangiectasis, ecchymosis and purpura particularly when occlusive dressings are used. The possibility of systemic absorption of the steroid and complications of steroid read_full_document