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)

Active ingredient:

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

Available from:

Baxter Healthcare Limited

ATC code:

B05DB

INN (International Name):

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

Dosage:

2.27 percent weight/volume

Pharmaceutical form:

Solution for Dialysis

Prescription type:

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

Therapeutic area:

Hypertonic solutions

Authorization status:

Marketed

Authorization date:

1993-06-03

Patient Information leaflet

1
CB-30-02-207
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 affecting your
abdominal wall or cavity or uncorrectable problem that increases risk
of abdominal infections.
•
if you have documented loss of peritoneal function due to severe
peritoneal

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 binders.
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
H
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_:
The mode of therapy, frequency