NUTRINEAL PD4 WITH

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 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.

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.

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.

2 g/kg body weight for adult dialysis patients. 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:

Safety and effectiveness in paediatric patients has not been established. If Nutrineal is used, the recommended posology is one peritoneal dialysis exchange per day. The clinical benefits of Nutrineal have to be balanced versus the risk of side effects in this patient category.

For paediatric patients > 2 years old, a fill volume of 800 to 1400 ml/m2 to a maximum amount of 2000 ml, as tolerated, has been recommended. Fill volumes of 200 to 1000 ml/m2 are recommended in children less than 2 years of age.

The adverse reactions within this section represent those that are thought to have an association with Nutrineal or in conjunction with performing the peritoneal dialysis procedure. Undesirables effects which occurred in patients treated with Nutrineal from clinical trials and post marketing are listed below.

0. The term has been retained to reflect the available source data. Other undesirable effects of peritoneal dialysis related to the procedure: catheter site infection, catheter related complication, hypocalcaemia and peritonitis bacterial.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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. - If any signs or symptoms of a suspected hypersensitivity reaction develop, intraperitoneal administration of Nutrineal should be stopped immediately.

Appropriate therapeutic measures should be instituted as clinically 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 hypokalaemia 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.

1, - 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.