EXTRANEAL PERITONEAL DIALYSIS SOLUTION 75 g/l

Therapeutic Indications

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

Contraindications

EXTRANEAL is contraindicated in patients with

• a known allergy to starch-based polymers (e.g. corn starch) and/or icodextrin

• maltose or isomaltose intolerance

• glycogen storage disease

• pre-existing severe lactic acidosis

• uncorrectable mechanical defects that prevent effective PD or increase the risk of infection

• documented loss of peritoneal function or extensive adhesions that compromise peritoneal function

Dosage and Method of Administration

Dosage

The volume to be instilled should be given over a period of approximately 10 to 20 minutes at a rate which patients find comfortable. For adult patients of normal body size the instilled volume should not exceed 2.0 litres. If this causes abdominal tension a 1.5 litre volume should be used. The recommended dwell time is between 6 and 12 hours in CAPD and 14–16 hours in APD

Administration:

• EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous administration.

• EXTRANEAL should be administered at a rate that is comfortable for the patient. The volume administered is determined by the prescribing physician.

• The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervised by the physician.

• Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort.

• Aseptic technique should be employed throughout the peritoneal dialysis procedure.

• Do not administer if the solution is discolored, cloudy, contains particulate matter or shows evidence of leakage, or if seals are not intact. In case of damage, the container should be discarded.

• The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.

• Discard any unused remaining solution.

• For single use only.

Special Populations:

• Adults: Use is limited to a single daily exchange for the long dwell, as part of a peritoneal dialysis regimen.

• Elderly: As for adults.

• Pediatrics: EXTRANEAL is not recommended in children.

  : Safety and effectiveness in pediatric patients have not been established.