Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
CALCIUM GLUBIONATE, CALCIUM LACTOBIONATE
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
A12AA06
CALCIUM GLUBIONATE, CALCIUM LACTOBIONATE
15ml 3.27g 2.18g Grams
Syrup
Product not subject to medical prescription
Calcium
Authorised
2016-07-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calcium Sandoz Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15ml contains 3.27g calcium glubionate and 2.18g calcium lactobionate. Three 5ml spoonfuls provide 325mg calcium (8.1 mmol:16.2mEq Ca++) Each 15ml also contains 4.54g of Sucrose. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Syrup Colourless to pale straw-coloured, fruit flavoured syrup 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS High-dose oral calcium in the form of Calcium Sandoz Syrup is indicated in the treatment of neonatal tetany, and as a therapeutic supplement in osteoporosis, post-gastrectomy malabsorption, osteomalacia, rickets, pregnancy and lactation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION USE IN CHILDREN The usual total daily dose is 30-50 ml. Neonatal hypocalcaemia: Calcium-Sandoz Syrup may be given at a dose of 1 mmol calcium/kg/24 hours in divided doses. Serum calcium levels should be monitored and the dosage adjusted if necessary. Doses may be mixed with the first (small) part of milk feeds. Note: 1 mmol of calcium is equivalent to 1.85 Calcium-Sandoz Syrup. USE IN THE ELDERLY No evidence exists that dosage or tolerance of Calcium Sandoz Syrup is directly affected by advanced age; however, elderly patients should be supervised as factors sometimes associated with ageing, such as poor diet or impaired renal function, may indirectly affect dosage or tolerance. (see also Precautions). ORAL DAILY DOSAGE INDICATION SYRUP Osteoporosis Post-gastrectomy malabsorption 60 – 100 ml Osteomalacia and rickets Lactation 20 – 60 ml Pregnancy supplement HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 15/07/2016_ _CRN 217 Прочетете целия документ