Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Zinc oxide; Calamine
Ovelle Limited
D02AB
Zinc oxide; Calamine
15 %w/v + 5 percent weight/volume
Cutaneous suspension
Product not subject to medical prescription
Zinc products
Marketed
1992-10-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calamine Lotion, cutaneous suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calamine 15% w/v Zine Oxide 5% w/v For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Cutaneous Suspension. Calamine Lotion is a pale pink lotion which separates on standing. It has a faint characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calamine Lotion is a mild astringent lotion recommended for the topical treatment of mild skin irritation and inflammation, including mild sunburn. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Calamine Lotion is applied topically to the affected area with cotton wool and allowed to dry. 4.3 CONTRAINDICATIONS Calamine Lotion is contraindicated in patients with a known sensitivity to its ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE No adverse effects reported. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Zinc oxide is incompatible with benzylpenicillin. Zinc oxide reacts slowly with fatty acid in oils and fats to produce the corresponding fatty acid esters. 4.6 FERTILITY, PREGNANCY AND LACTATION No adverse effects reported. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No adverse effects reported. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _4_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _9_ _6_ _1_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.8 UNDESIRABLE EFFECTS None reporte Прочитайте повний документ