CAPD/DPCA 18 %v/v Solution for Dialysis

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

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

可用日期:

Fresenius Medical Care Deutschland GmbH

INN（国际名称）:

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

剂量:

%v/v

药物剂型:

Solution for Dialysis

处方类型:

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

授权状态:

Withdrawn

授权日期:

2010-02-16

产品特点

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