Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Nystatin
Imbat Limited
A07AA; A07AA02
Nystatin
100,000 unit(s)/millilitre
Oral suspension
Product subject to prescription which may be renewed (B)
Antibiotics; nystatin
Authorised
2008-02-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mycostatin 100,000 units/ml Oral Suspension (Ready-Mixed) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre of suspension contains 100,000 units nystatin. Excipient: sucrose and parahydroxybenzoates. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Suspension _Product imported from Portugal:_ Light creamy, yellow suspension 4 CLINICAL PARTICULARS As per PA0002/007/007 5 PHARMACOLOGICAL PROPERTIES As per PA0002/007/007 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Imitation cherry flavour Cinnamic aldehyde Ethanol Glycerol Parahydroxybenzoates Peppermint oil Carboxymethylcellulose Sodium phosphate Sucrose Water 6.2 INCOMPATIBILITIES Not applicable . 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE 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_ _ _ _0_ _9_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ _2_ _1_ _8_ _2_ _7_ _2_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ Do not store above 25°C. Do not freeze. 6.5 NATURE AND CONTENTS OF CONTAINER Amber glass bottle packed in a cardboard carton with a measuring dropper. Pack size 30ml. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Shake well before use. Perskaitykite visą dokumentą