Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Sodium chloride ; Potassium chloride; Glucose; Disodium hydrogen citrate
Sanofi-Aventis Ireland Limited T/A SANOFI
A07CA
Sodium chloride ; Potassium chloride; Glucose; Disodium hydrogen citrate
0.47/0.30/3.56/0.53 gram(s)
Powder for oral solution
Oral rehydration salt formulations
2020-02-14
PACKAGE LEAFLET: INFORMATION FOR THE USER DIORALYTE REBALANCE NATURAL/CITRUS/BLACKCURRANT POWDER FOR ORAL SOLUTION _glucose, sodium chloride, potassium chloride, disodium hydrogen citrate _ _ _ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 4035600 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DIORALYTE REBALANCE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 24-36 hours. IN THIS LEAFLET: 1. What Dioralyte Rebalance is and what it is used for 2. What you need to know before you take Dioralyte Rebalance 3. How to take Dioralyte Rebalance 4. Possible side effects 5. How to store Dioralyte Rebalance 6. Contents of the pack and other information 1. WHAT DIORALYTE REBALANCE IS AND WHAT IT IS USED FOR Dioralyte Rebalance is an oral rehydration therapy containing a balanced combination of electrolytes which include glucose, sodium chloride, potassium chloride and disodium hydrogen citrate. It is recommended for the replacement of essential water and salt loss which can happen for various reasons including when you have diarrhoea. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIORALYTE REBALANCE DO NOT TAKE DIORALYTE REBALANCE AND TALK TO YOUR DOCTOR OR PHARMACIST IF: • You are allergic (hypersensitive) to glucose, sodium chloride, potassium chloride and disodium hydrogen citrate or any of the other ingredients of Dioralyte Rebalance (see Section 6: Contents of the pack and other information) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue • Your bowel is partially or fully bl Pročitajte cijeli dokument
Health Products Regulatory Authority 13 May 2021 CRN009T1N Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dioralyte Rebalance Blackcurrant Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: Sodium Chloride Ph.Eur 0.47g Potassium Chloride Ph.Eur 0.30g Glucose Ph.Eur 3.56g Disodium Hydrogen Citrate B.P 0.53g Excipients: Also includes ethanol, less than 100mg per dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. White, homogeneous, granular powder with an odour and taste of blackcurrant. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dioralyte Rebalance is indicated for use in infants, children and adults for the oral correction of fluid and electrolyte loss of gastrointestinal origins and in the management of watery diarrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The contents of each sachet should be dissolved 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 up to the age of 24 months and 20-40 ml/kg body weight for adults and children. A reasonable approximation is: Infants under 24 months Use only under medical advice. One to one and a half times the usual 24 hour feed volume. Children over 24 months One sachet after every loose stool. Adults including elderly One or two sachets after every loose stool. More may be required initially to ensure early and full volume repletion. If diarrhoea persists for longer than 24 to 36 hours the patient should be seen by a doctor. Do not exceed the maximum daily dose of 1 Pročitajte cijeli dokument