Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
CALCIUM GLUBIONATE CALCIUM LACTOBIONATE
Novartis Consumer Health UK Limited
3.27/2.18 g/15ml Grams
Syrup
1998-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0030/047/001 Case No: 2043297 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to NOVARTIS CONSUMER HEALTH UK LTD TRADING AS NOVARTIS CONSUMER HEALTH, WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CALCIUM SANDOZ SYRUP The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 01/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/11/2009_ _CRN 2043297_ _page number: 1_ PART II 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, Aqra d-dokument sħiħ