NUTRINEAL PD4 WITH 1.1% AMINO ACID SOLUTION

1. Therapeutic Indications

Nutritional supplement for malnourished renal failure patients (albumin concentration lower than 35g/litre) being maintained on peritoneal dialysis.

3. Contraindication

NUTRINEAL is contraindicated in patients with:

• known hypersensitivity to any amino acids in the product or to any of the excipients
• Serum urea level above 38mmol/L
• uremic symptoms
• metabolic acidosis
• inborn errors of amino acid metabolism
• liver insufficiency
• severe hypokalemia
• 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

2. Dosage and Method of Administration

Administration:

• NUTRINEAL is intended for intraperitoneal administration only. Not for intravenous administration.
• The intraperitoneal administration route requires the use of a specific peritoneal dialysis catheter and an appropriate administration set which connects the solution container to the patient's catheter.
• NUTRINEAL 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 prescribing physician.
• Treatment should be re-evaluated after 3 months if there is no clinical or biochemical improvement in the status of the patient.
• Do not remove unit from over pouch until ready for use.
• 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 through the peritoneal dialysis procedure.
• Do not administer unless the solution is clear and free of particulate matter.
• In case of damage, the container should be discarded.
• Discard any unused remaining solution
• For single use only

Dosage:

• Dosage schedule, frequency of treatment and duration of dwell should be selected by the prescribing physician according to the patient's clinical status.
• Recommended dietary allowance of protein is approximately 1.2–1.3 g/kg for dialysed adults and 2–3 g/kg for infants. Higher amounts may be necessary in several catabolic states.
• For information, a 2-litre bag of Nutrineal with 1.1% amino acids provides 22g of amino acids which are equivalent to 0.30g/kg/day for a 70kg adult.
• Safety and effectiveness in pediatric patients has not been established.