Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
GLUCOSE MONOHYDRATE SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE SODIUM LACTATE
Baxter Healthcare Limited
Solution for Haemofiltration
1999-11-26
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0167/103/001 Case No: 2044285 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to BAXTER HEALTHCARE LIMITED CAXTON WAY, THETFORD, NORFOLK IP24 3SE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product MONOSOL. SOLUTION FOR HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION 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 08/06/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/03/2010_ _CRN 2044285_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Monosol Solution for haemodialysis, haemodiafiltration and haemofiltration 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for haemodialysis, haemodiafiltration and haemofiltration Monosol is a sterile, non-pyrogenic, clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As substitution solution in continuous hemofiltration and hemodiafiltration and as dialysis solution in continuous hemodialysis and hemodiafiltration for acute renal failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Substitution fluid Lugege kogu dokumenti