Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LACTULOSE
Novartis Consumer Health UK Limited
67 %w/v
Oral Solution
1998-03-14
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0030/043/001 Case No: 2061350 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 WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product LACTULOSE LIQUID PH. EUR. 67% W/V ORAL SOLUTION 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 12/06/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/06/2009_ _CRN 2061350_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lactulose Liquid Ph. Eur. 67% w/v Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of Lactulose Solution contains 3.35 g of Lactulose. Excipients: also includes Lactose and Galactose <1.34g per 5ml For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral Solution Clear to almost colourless to pale yellow syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic constipation. Chronic portal systemic encephalopathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION CHRONIC CONSTIPATION Because lactulose acts naturally to encourage the normal activity of the b Read the complete document