CALCIUM SANDOZ

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

CALCIUM GLUBIONATE CALCIUM LACTOBIONATE

Available from:

Novartis Consumer Health UK Limited

Dosage:

3.27/2.18 g/15ml Grams

Pharmaceutical form:

Syrup

Authorization date:

1998-04-01

Summary of Product characteristics

                                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,
                                
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