Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
SODIUM BICARBONATE DILL SEED OIL TERPENELESS
SSL International PLC
SODIUM BICARBONATE DILL SEED OIL TERPENELESS
0.69mg/5ml %v/v
Product not subject to medical prescription
Withdrawn
2011-03-03
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Woodward’s Gripe Water Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium Hydrogen Carbonate 52.5 mg/5ml Terpeneless Dill Seed Oil 0.69 mg/5ml For excipients, see 6.1 3 PHARMACEUTICAL FORM Oral solution. A clear, colourless to very pale straw liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of distress associated with wind in infants up to one year old. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Adults and the elderly: not applicable Children: 1-6 months old: one 5ml spoonful 6-12 months old: two 5ml spoonfuls Under one month old: not to be used These doses may be given during or after each feed or up to six times in 24 hours. 4.3 CONTRAINDICATIONS Should not be used where impaired kidney function or hypersensitivity to hydroxybenzoates exists. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist, medical advice should be sought. Keep all medicines out of the reach of children. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/10/2007_ _CRN 2042535_ _page number: 1_ 4.6 PREGNANCY AND LACTATION Not applicable. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS None known. 4.9 OVERDOSE Symptoms following overdose are rare and are generally due to the effects of sodium bicarbonate. These may include diarrhoea, metabolic alkalosis and hypernatraemia. In the event of severe o Perskaitykite visą dokumentą