Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE
Fresenius Medical Care Deutschland GmbH
SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE
%v/v
Solution for Dialysis
Product subject to prescription which may not be renewed (A)
Withdrawn
2010-02-16
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CAPD/DPCA 19, Solution for Peritoneal Dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 litre contains: Theoretical osmolarity 399 mosm/l pH 5.5 For excipients, _see Section 6.1_ 3 PHARMACEUTICAL FORM Solution for Peritoneal Dialysis Clear colourless to slightly yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in patients with end-stage (decompensated) chronic renal failure of any origin which can be treated with peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE CAPD/DPCA 19 is exclusively indicated for intraperitoneal use. The mode of therapy, frequency of administration, and dwell time required will be specified by the attending physician. Continuous ambulatory peritoneal dialysis (CAPD) Unless otherwise prescribed, patients will receive 2,000 ml solution per exchange four times a day (corresponding to a Sodium chloride 5.786 g Sodium-(S)-lactate solution 7.85 g equivalent to 3.925 g sodium-(S)-lactate Calcium chloride x 2 H O 0.1838 g Magnesium chloride x 6 H O 0.1017 g Glucose monohydrate 25.00 g equivalent to 22.73 g/l anhydrous glucose and up to 1.1 g/l fructose Na+ 134.00 mmol/l Ca++ 1.25 mmol/l Mg++ 0.50 mmol/l Cl - 102.50 mmol/l (S)-lactate 35.00 mmol/l Glucose 126.1 mmol/l 2 2 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/12/2009_ _CRN 2075802_ _page number: 1_ daily dose of 8,000 ml). After a dwell time between 2 and 10 hours the solution will be drained. Adjustment of dosage will be necessary for individual patients. If pain due to abdominal distension occurs at the commencement of peritoneal dialysis treatment, the solution volume per exchange should be reduced. Children receive Les hele dokumentet