CAPD/DPCA 19 %v/v Solution for Dialysis

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE

Tilgjengelig fra:

Fresenius Medical Care Deutschland GmbH

INN (International Name):

SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE GLUCOSE MONOHYDRATE

Dosering :

%v/v

Legemiddelform:

Solution for Dialysis

Resept typen:

Product subject to prescription which may not be renewed (A)

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2010-02-16

Preparatomtale

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�