DIANEAL PD4 GLUCOSE 2.27 % W/V (22.7 MG/ML), SOLUTION FOR PERITONEAL DIALYSIS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
GLUCOSE SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE
Available from:
Baxter Healthcare Limited
Dosage:
2.27 %w/v
Pharmaceutical form:
Solution for Dialysis
Authorization date:
1993-06-03
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dianeal PD4 Glucose 2.27 % w/v (22.7 mg/ml), Solution for peritoneal dialysis.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
MMOL/L
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Peritoneal Dialysis.
A clear colourless to pale yellow, solution in PVC containers, which may have an integral administration set and
drainage bag.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dianeal PD4 is indicated whenever peritoneal dialysis is employed, including:
1.
Acute and chronic renal failure.
2.
Severe water retention.
3.
Electrolyte disorders.
4.
Drug intoxication, when a more adequate therapeutic alternative is not available.
Dianeal PD4 is particularly useful for the control of serum calcium and phosphate levels in renal failure patients
receiving calcium or magnesium-containing phosphate binder s.
Anhydrous Glucose
2.27 %
w/v
22.70
g/L
or
Glucose Monohydrate
2.50 %
w/v
25.00
g/L
Sodium Chloride
0.538 %
w/v
5.38
g/L
Sodium Lactate
0.448 %
w/v
4.48
g/L
Calcium Chloride Dihydrate
0.0184 %
w/v
184.00
mg/L
Magnesium Chloride Hexahydrate
0.0051 %
w/v
51.00
mg/L
Na
+
132.00
Ca
2+
1.25
Mg
2+
0.25
Cl
-
95.00
C
3
H
5
O
3
-
40.00
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 08/02/2012_
_CRN 2107266_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Administration_
DIANEAL PD4 is intended for intraperitoneal administration only. Not for intravenous administration.
Peritoneal dialysis solutions may be warmed to 37°C to enhance patient comfort. However, only dry heat (for example,
heating pad, warming plate) should be used. Solutions should not be heated in water due to an increased risk of
contamination. Solutions should not be heated
Read the complete document
