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 anhydrous ; Glucose monohydrate; Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate

Available from:

Baxter Holding B.V.

ATC code:

B05DB

INN (International Name):

Glucose anhydrous ; Glucose monohydrate; Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate

Dosage:

3.86 percent weight/volume

Pharmaceutical form:

Solution for peritoneal dialysis

Therapeutic area:

Hypertonic solutions

Authorization status:

Marketed

Authorization date:

1993-06-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIANEAL PD4 GLUCOSE 1.36% W/V / 13.6 MG/ML
DIANEAL PD4 GLUCOSE 2.27% W/V / 22.7 MG/ML
DIANEAL PD4 GLUCOSE 3.86% W/V / 38.6 MG/ML
SOLUTIONS FOR PERITONEAL DIALYSIS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What DIANEAL PD4 is and what it is used for
2.
What you need to know before you use DIANEAL PD4
3.
How to use DIANEAL PD4
4.
Possible side effects
5.
How to store DIANEAL PD4
6.
Contents of the pack and other information
1.
WHAT DIANEAL PD4 IS AND WHAT IT IS USED FOR
DIANEAL PD4 is a solution for peritoneal dialysis.
It removes water and waste products from the blood. It also corrects
abnormal levels of different
blood components. DIANEAL PD4 contains varying levels of glucose
(1.36%, 2.27% or 3.86%).
The higher the strength of glucose in the solution, the greater the
amount of water that will be
removed from the blood.
DIANEAL PD4 may be prescribed to you if you have:

either temporary or permanent kidney failure

severe water retention

severe disturbances in the acidity or alkalinity and the level of
salts in your blood

certain types of drug intoxication where no other treatments are
available.
DIANEAL PD4 is particularly indicated for the control of your serum
calcium and phosphate levels
if you receive calcium or magnesium containing phosphate binders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIANEAL PD4
DO NOT USE DIANEAL PD4

If you are allergic to active substances or any of the other
ingredients of this medicine (listed
in section 6).

If you have severe lactic acidosis (too much acid in the blood) before
you use this solution
for the first time.

If you have a surgically uncorrectable problem affe

Summary of Product characteristics

Health Products Regulatory Authority
19 November 2019
CRN009GH0
Page 1 of 7
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
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
MMOL/L
Na
+
132.00
Ca
2+
1.25
Mg
2+
0.25
Cl
-
95.00
C
3
H
5
O
3
-
40.00
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_:
The mode of therapy, frequency of treatment, exchange volume, duration
of dwell and length of dialysis should be selected by
the attending physician.
Adults
Health Products Regulatory Authority
19 November 2019
CRN009GH0
Page 2 of 7
Patients on continuous ambulatory peritoneal dialysis (CAPD) typically
perform 4 cycles per day (24 hours). Patients on
automated peritoneal dialysis (APD) typically perform 4-5 cycles at
night and up to 2 cycles during the day. The fill volume
depends on body size, usually from 2.0 to 2.5 litres.
Paediatric population (i.e., newborn to 18 years of age)
800 to 1400 ml/m2 per cycle up to a maximum amount of 2000 ml, as
tolerated, is recommended. Fil