Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
GLUCOSE ANHYDROUS
B. Braun Medical Limited
GLUCOSE ANHYDROUS
50 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-08-15
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0179/001/036 Case No: 2040927 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B. BRAUN MEDICAL LIMITED 3 NAAS ROAD INDUSTRIAL PARK, DUBLIN 12, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product GLUCOSE INTRAVENOUS INFUSION BP 50% W/V, SOLUTION FOR INFUSION (500 ML) 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 27/03/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/03/2008_ _CRN 2040927_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucose Intravenous Infusion BP 50% w/v, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml contains 0.5 g anhydrous glucose, as glucose monohydrate. 1000 ml of solution contain 500 ml of solution contain Anhydrous glucose 500.0 g 250.0 g (as glucose monohydrate) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear, colourless or slightly yellowish aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Parenteral nutrition; High-caloric carbohydrate therapy, especially when fluid intake is restricted, as Les hele dokumentet