देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: 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 17, Solution for Peritoneal Dialysis 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 2 O 0.1838 g Magnesium chloride x 6 H 2 O 0.1017 g Glucose monohydrate 16.50 g equivalent to 15.0 g/l anhydrous glucose and up to 0.75 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 83.20 mmol/l Theoretical osmolarity 356 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 17 is exclusively indicated for intraperitoneal use. The mode of therapy, frequency of administration, and dwell time required will be specified by the attending physician. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/12/2009_ _CRN 2075719_ _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 पूरा दस्तावेज़ पढ़ें