DIANEAL PD-4 PERITONEAL DIALYSIS SOLUTION WITH 2.27 % GLUCOSE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CALCIUM CHLORIDE; GLUCOSE; GLUCOSE AS MONOHYDRATE; LACTIC ACID AS SODIUM; MAGNESIUM CHLORIDE; SODIUM CHLORIDE

Available from:

BAXTER HEALTHCARE DISTRIBUTION LTD., ISRAEL

Pharmaceutical form:

SOLUTION FOR PERITONEAL DIALYSIS

Composition:

LACTIC ACID AS SODIUM 4.5 G/L; SODIUM CHLORIDE 5.4 G/L; GLUCOSE 22.7 G/L; CALCIUM CHLORIDE 0.184 G/L; MAGNESIUM CHLORIDE 0.051 G/L; GLUCOSE AS MONOHYDRATE 25 G/L

Administration route:

PERITONEAL DIALYSIS

Prescription type:

Required

Manufactured by:

BAXTER HEALTHCARE S.A, IRELAND

Therapeutic indications:

Indicated whenever peritoneal dialysis is employed including acute and chronic renal failure, severe water retention, electrolyte disorders, drug intoxication.

Authorization date:

2020-04-30

Patient Information leaflet

لوانتت ة
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ازيلايدلا زكرم وأ بيبطلا غلابإ بجي
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داتعملا نم رثكأ عفترم مد طغض
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
Dianeal PD4 Peritoneal Dialysis Solution with 1.36% Glucose
Dianeal PD4 Peritoneal Dialysis Solution with 2.27% Glucose
Dianeal PD4 Peritoneal Dialysis Solution with 3.86% Glucose
1.
NAME OF THE MEDICINAL PRODUCT
Dianeal PD4 Peritoneal Dialysis Solution with 1.36% Glucose
Dianeal PD4 Peritoneal Dialysis Solution with 2.27% Glucose
Dianeal PD4 Peritoneal Dialysis Solution with 3.86% Glucose
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_DIANEAL PD4 PERITONEAL DIALYSIS SOLUTION WITH 1.36% W/V GLUCOSE _
Glucose (as monohydrate)
Ph.Eur.
1.36% w/v
Sodium Chloride
Ph.Eur.
0.538% w/v
Sodium Lactate
Ph.Fr. + internal specification
0.448% w/v
Calcium Chloride
Ph.Eur.
0.0184% w/v
Magnesium Chloride
Ph.Eur.
0.0051% w/v
_DIANEAL PD4 PERITONEAL DIALYSIS SOLUTION WITH 2.27% W/V GLUCOSE _
Glucose (as monohydrate)
Ph.Eur.
2.27% w/v
Sodium Chloride
Ph.Eur.
0.538% w/v
Sodium Lactate
Ph.Fr. + internal specification
0.448% w/v
Calcium Chloride
Ph.Eur.
0.0184% w/v
Magnesium Chloride
Ph.Eur.
0.0051% w/v
_DIANEAL PD4 PERITONEAL DIALYSIS SOLUTION WITH 3.86% W/V GLUCOSE _
Glucose (as monohydrate)
Ph.Eur.
3.86% w/v
Sodium Chloride
Ph.Eur.
0.538% w/v
Sodium Lactate
Ph.Fr. + internal specification
0.448% w/v
Calcium Chloride
Ph.Eur.
0.0184% w/v
Magnesium Chloride
Ph.Eur.
0.0051% w/v
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Clear solution.
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.
Route of administration
Intraperitoneal administration only.
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
Patients on continuous ambulatory peritoneal dialysis (CAPD) typically
perform 4
cycles per day (24 hour