CAPD/DPCA 19 %v/v Solution for Dialysis

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Fresenius Medical Care Deutschland GmbH

INN (Jina la Kimataifa):

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

Kipimo:

%v/v

Dawa fomu:

Solution for Dialysis

Dawa ya aina:

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

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2010-02-16

Tabia za bidhaa

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�