Icodextrin

Icodextrin

1. Name of the medicinal product

EXTRANEAL (Icodextrin 7.5%)

Solution for peritoneal dialysis

2. Qualitative and quantitative composition

A sterile peritoneal dialysis fluid containing Icodextrin at a concentration of 7.5% w/v in an electrolyte solution.

Icodextrin 75 g/L
Sodium Chloride 5.4 g/L
Sodium S-Lactate 4.5 g/L
Calcium Chloride 0.257 g/L
Magnesium Chloride 0.051 g/L

Theoretical osmolarity: 284 (milliosmoles per litre)

Theoretical osmolality: 301 (milliosmoles per kg)

Electrolyte solution content per 1000 ml:

Sodium 133 mmol/L
Calcium 1.75 mmol/L
Magnesium 0.25 mmol/L
Chloride 96 mmol/L
Lactate 40 mmol/L

pH = 5 to 6

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Solution for peritoneal dialysis.

Extraneal is a sterile, clear, colorless solution.

4. Clinical particulars
4.1 Therapeutic indications

Extraneal is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients.

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