Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE
Fresenius Medical Care Deutschland GmbH
Solution for Dialysis
2000-06-14
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT CAPD/DPCA 18, Solution for Peritoneal Dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Na+ 134 mmol/l Ca++ 1.25 mmol/l Mg++ 0.50 mmol/l Cl - 102.50 mmol/l (S)-lactate 35.00 mmol/l Glucose 235.80 mmol/l Theoretical osmolarity 509.00 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 18 is exclusively indicated for intraperitoneal use. The mode of therapy, frequency of administration, and dwell time required will be specified by the attending physician. 1 litre contains: 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 46.75 g equivalent to 42.5 g/l anhydrous glucose and up to 2.1 g/l fructose 2 2 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/12/2009_ _CRN 2075687_ _page number: 1_ Continuous ambulatory peritoneal dialysis (CAPD) Unless otherwise prescribed, patients will receive 2,000 ml solution per exchange four times a day (corresponding to a 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 Lire le document complet