Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE POTASSIUM CHLORIDE GLUCOSE SODIUM CITRATE ACID
G & A Licensing Limited
0.47/0.3/3 Grams
Powder for Oral Solution
2010-06-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dioralyte Blackcurrant Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: Exipients-Also contains ethanol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution _Product imported from UK_: White, homogeneous, granular powder with an odour and taste of blackcurrant 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the oral correction of fluid and electrolyte loss and in the management of watery diarrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The basic unit of dosage is the content of a single sachet reconstituted in 200ml (approximately 7 fluid ounces) of drinking water. Use fresh drinking water for adults and children. For infants where drinking water is unavailable the water should be freshly boiled and cooled. The solution should be made up immediately before use. If refrigerated, the solution may be stored for up to 24 hours, otherwise any solution remaining an hour after reconstitution should be discarded. The solution must not be boiled after reconstitution. Daily intake may be based on a volume of 150ml/kg body weight for infants and 20-40 mg/kg body weight for adults and children. A reasonable approximation is: Infants – One to one and a half times the usual feed volume. For infants under 12 months, use only under medical advice. Children – One sachet after every loose motion. Adults including elderly – One or two sachets after every loose motion. More may be required initially to ensure early and full volume repletion. Sodium Chloride Ph. Eur 0.47g Potassium Chloride Ph. Eur 0.30g Glucose Ph. Eur 3.56g Disodium Hydrogen Citrate B.P 0.53g IRISH MEDICINES BOARD _________________________________________________________ Read the complete document