Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
B. Braun Melsungen AG
POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE
6 %w/w
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Withdrawn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) PA0736/020/003 Case No: 2052630 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B. BRAUN MELSUNGEN AG CARL-BRAUN STRASSE 1, 34212 MELSUNGEN, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product VENOFUNDIN 60MG/ML SOLUTION FOR INFUSION, ECOBAG 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 17/12/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/01/2010_ _CRN 2052630_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Venofundin 6% w/v solution for infusion, Ecobag 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml contains Poly(O-2-hydroxyethyl)starch (HES) 60.0 g (Molar substitution: 0.42) (Mean molecular weight: 130,000 Da) Sodium chloride 9.0 g _Electrolyte concentration:_ Sodium 154 mmol/l Chloride 154 mmol/l For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion. Clear, colorless aqueous solution. pH: 4.0 6.5 Theoretical osmolarity: 309 mOsmol/l Titration acidity: <1.0 mmol/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of imminent or manifest hypovolaemia and shock. 4.2 POSOLOGY AND MET Lugege kogu dokumenti