国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE ANHYDROUS SODIUM LACTATE
Fresenius Medical Care Deutschland GmbH
SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE ANHYDROUS SODIUM LACTATE
2.3%/1.75mmol/l %v/v
Soln for Peritoneal Dialysis
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-02-16
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0953/005/003 Case No: 2066197 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH D-61346 BAD HOMBURG, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product _BALANCE _2.3% GLUCOSE, 1.75MMOL/L CALCIUM, SOLUTION FOR PERITONEAL DIALYSIS 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 17/11/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/01/2010_ _CRN 2066197_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT _balance _2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _balance _2.3% glucose, 1.75 mmol/l calcium is delivered in a double chamber bag. One chamber contains the alkaline lactate solution, the other chamber contains the acidic glucose-based electrolyte solution. Mixing of both solutions by opening the middle seam between the two chambers results in the neutral ready-to-use solution. BEFORE RECONSTITUTION 1 litre of acidic glucose based electrolyte solution contains: Sodium chloride 11.279 g Calcium chloride dihydrate 0.514 完全なドキュメントを読む