Nutrineal PD-4 with 1.1% Amino Acids Solution for Peritoneal Dialysis

/ Teva

Administration: NUTRINEAL is intended for intraperitoneal administration only. Not for intravenous administration.
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 due to an increased risk of contamination. Solutions should not be heated in a microwave oven due to the potential for damage to the solutions container and 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 peritonitis.
For single use only.
Posology: 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.
Adults: one peritoneal dialysis exchange per day of one 2.0 l or one 2.5 l bag is the recommended dose for a 70 kg body weight patient. In smaller patients the fill volume may need to be reduced depending on body size. In exceptional cases, a different posology may be indicated but the dose should not exceed two exchanges per day. Note that the recommended daily total intake of proteins is over or equal to 1.2 g/kg body weight for adult dialysis patients. A 2.0 l bag of Nutrineal contains 22 g of amino acids which corresponds to 0.30 g/kg body weight/24 h (approximately 25% of the daily protein requirements) for an adult dialysis patient of 70 kg body weight.
Elderly: as for adults.
Children and adolescents: The recommended posology is one peritoneal dialysis exchange per day. The risk/benefit ratio should be assessed and individual dialysis prescription is necessary which includes appropriate adaptation of fill volumes.

Nutrineal is a supplement for malnourished renal failure patients (albumin concentration lower than 35 g/liter) being maintained on peritoneal dialysis.

– known hypersensitivity to any amino acids in the product or to any of the excipients.
– serum urea level above 38 mmol/L,
– uraemic symptoms,
– metabolic acidosis,
– inborn errors of amino acid metabolism,
– liver insufficiency,
– severe hypokalaemia,
– 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.

Encapsulating peritoneal sclerosis (EPS) is considered to be a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including NUTRINEAL
– If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated.
– Metabolic acidosis should be corrected before and during Nutrineal treatment.
– Safety and effectiveness in paediatric patients has not been established.
– Significant losses of medicinal products (including water soluble vitamins) may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.
– Dietary protein intake should be monitored
– Peritoneal dialysis should be done with caution in patients with: 1) abdominal conditions, including disruption of the peritoneal membrane and diaphragm by surgery, from congenital anomalies or trauma until healing is complete, abdominal tumours, abdominal wall infection, hernias, faecal fistula, colostomy or iliostomy, frequent episodes of diverticulitis, inflammatory or ischemic bowel disease, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity; and 2) other conditions including aortic graft placement and severe pulmonary disease.
– Overinfusion of a peritoneal dialysis solution into the peritoneal cavity may be
characterised by abdominal distension/abdominal pain and/or shortness of breath.
– Treatment of peritoneal dialysis solution overinfusion is to drain the solution from the peritoneal cavity.
– Patients should be carefully monitored to avoid over- and underhydration. An accurate fluid balance record should be kept and the patient’s body weight monitored.
– Potassium is omitted from NUTRINEAL solutions due to the risk of hyperkalaemia.
In situations in which there is a normal serum potassium level or hypokalaemia, the addition of potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia and should be made after careful evaluation of serum and total body potassium, only under the direction of a physician.
– Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone) and haematological parameters should be monitored periodically.
– In diabetic patients, blood glucose levels should be regularly monitored and the dosage of insulin or other treatment for hyperglycaemia should be adjusted.
– A portion of the amino acids in Nutrineal is converted to metabolic nitrogenous waste, such as urea. If dialysis is insufficient, the additional metabolic waste generated by the use of Nutrineal may lead to the appearance of uraemic symptoms such as anorexia or vomiting. Symptoms can be managed by reduction of the number of Nutrineal exchanges, or discontinuation of Nutrineal or an increased dialysis dose with a non amino acid based solution.
– In patients with secondary hyperparathyroidism, the benefits and risks of the use of dialysis solution with a low calcium content should be carefully considered as it might worsen hyperparathyroidism.

Very common: Acidosis, Hypervolaemia, Vomiting, Nausea, Gastritis,
Asthenia, Blood urea increased.
Common: Infection, Anaemia, Hypokalaemia, Hypovolaemia, Depression,
Dyspnoea, Abdominal pain.
See prescribing information for full details.

No interaction studies have been conducted with NUTRINEAL. Blood concentration of other dialysable medicinal products may be reduced during dialysis.
Plasma levels of potassium, calcium and magnesium in patients using cardiac glycosides must be carefully monitored, as there is a risk of digitalis intoxication. Potassium supplements may be necessary.

There are no clinical data on exposed pregnancies and lactation, and no animal studies are available. Nutrineal should not be used during pregnancy or lactation unless clearly necessary.

There is potential for overdose resulting in hypervolaemia and electrolyte disturbances.
Management of Overdose: Hypervolaemia may be managed by using hypertonic peritoneal dialysis solutions and fluid restriction.
Electrolyte disturbances may be managed according to the specific electrolyte disturbance verified by blood testing. The most probable disturbance, hypokalaemia, may be managed by the oral ingestion of potassium or by the addition of potassium chloride in the peritoneal dialysis solution prescribed by the treating physician.

Incompatibilities: Nutrineal PD4 in the PVC container should not be mixed with other medicinal products.
Storage: Store below 30°C. Keep in the original container.