EXTRANEAL Solution for peritoneal dialysis Ref.[50603] Active ingredients: Calcium chloride Lactic acid Magnesium chloride Sodium chloride

Posology

Extraneal is recommended for use during the longest dwell period, i.e. in CAPD usually overnight and in APD for the long daytime dwell.

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

Adults

By intraperitoneal administration limited to a single exchange in each 24 hour-period, as part of a CAPD or APD regimen.

The volume to be instilled should be given over a period of approximately 10 to 20 minutes at a rate which the patient finds comfortable. For adult patients of normal body size the instilled volume should not exceed 2.0 L. For larger patients (more than 70-75 kg), a fill volume of 2.5 L may be used.

If the instilled volume causes discomfort due to abdominal tension the instilled volume should be reduced. The recommended dwell time is between 6 and 12 hours in CAPD and 14-16 hours in APD. Drainage of the fluid is by gravity at a rate comfortable for the patient.

Older people

As for Adults.

Paediatric population

The safety and efficacy of Extraneal in children aged less than 18 years has not been established. No data are available.

Administration:

Precautions to be taken before handling or administering the medicinal product

• EXTRANEAL is intended for intraperitoneal administration only. Not for intravenous injection.
• Peritoneal dialysis solutions may be warmed in the overpouch to 37°C 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 discoloured, cloudy, contains particulate matter or shows evidence of leakage, or if seals are not intact.
• The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of infection or aseptic peritonitis (see Section 4.4).
• For single use only

No data are available on the effects of overdosage. However, continuous administration of more than one bag of Extraneal in 24 hours would increase plasma levels of carbohydrate metabolites and maltose. The effects of such an increase are unknown but an increase in plasma osmolality may occur. Treatment could be managed by Icodextrin-free peritoneal dialysis or haemodialysis.

2 years.

12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).

The product, once removed from its overpouch should be used immediately.

Do not store below 4°C.

Do not use unless the solution is clear and the container undamaged.

Flexible PVC container holding 1.5, 2.0 or 2.5 litres.

Not all pack sizes may be marketed.

For details see section 4.2

A range of antibiotics including vancomycin, cephazolin, ampicillin/flucloxacillin, ceftazidime, gentamycin, amphotericin and insulin have shown no evidence of incompatibility with Extraneal. However aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

The product should be used immediately after adding any drug. Discard any unused remaining solution.