DIANEAL PD4 GLUCOSE 3.86 % W/V (38.6 MG/ML), SOLUTION FOR PERITONEAL DIALYSIS.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLUCOSE SODIUM CHLORIDE SODIUM LACTATE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE

Available from:

Baxter Healthcare Limited

Dosage:

3.86 %w/v

Pharmaceutical form:

Solution for Dialysis

Authorization date:

1993-06-03

Summary of Product characteristics

License
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Dianeal PD4 Glucose 3.86 % w/v (38.6 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 binders.
Anhydrous Glucose
3.86 %
w/v
38.60
g/L
or
Glucose Monohydrate
4.25 %
w/v
42.50
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 Posol