Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
GELATINE POLYSUCCINATE SODIUM CHLORIDE SODIUM HYDROXIDE
B. Braun Medical Limited
GELATINE POLYSUCCINATE SODIUM CHLORIDE SODIUM HYDROXIDE
4 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0179/038/001 Case No: 2035401 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 GELOFUSINE, SOLUTION FOR INFUSION 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 14/10/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/11/2007_ _CRN 2035401_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gelofusine, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear, colourless or slightly yellowish, aqueous solution with a pH of 7.1-7.7 and an osmolarity of 274 mOsm/l. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a plasma volume substitute for use in the initial management of hypovolaemic shock due to blood or plasma loss, dehydration or peri-operative loss of circulating fluid. The solution can be used for haemodilution and as a priming solution for extracorporeal circulation systems and as a carr Prečítajte si celý dokument