Kabiven Perifer

The dose should be individualized and the choice of bag size should be made with regard to the patient's clinical condition, body weight, and nutritional requirements

Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-030 g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day); The corresponding commonly accepted requirements are 2-6 g for glucose and 1.0-2.0 g for fat.

The total energy requirement depends on the patient's clinical condition and is often between 20-30 kcal/kg/day In obese patients, the dose should be based on the estimated ideal weight. This solution is produced in three sizes intended for patients with moderately increased, basal or low nutritional requirements. To provide total parenteral nutrition, the addition of trace elements, vitamins and supplemental electrolytes may be required. The dose range of 0.10-0 15 g N/kg/day (0.7-1.0 g amino acid/kg/day) and total energy of 20-30 kcal body weight/day corresponds to approx. 27-40 ml/kg/day.

Children: The ability to metabolize individual nutrients must determine the dosage. In general the infusion for small children (2-10 years) should start with a low dose l.e. 14-28 ml/kg (corresponding to 0.49-0.98 g fat/kg/day, 0.34-0.67 g amino acids/kg/day and 0.95-1.9 g glucose/kg/day) and increased by 10-15 ml/kg/day up to maximum dosage of 40 ml/kg/day. For children over 10 years of age the dosage for adults can be applied. The use of this solution is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.

The infusion may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence<1 %). Transient increases in liver enzymes during intravenous nutrition have also been reported. Reports of other undesirable effects in conjunction with the included components are extremely rare. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haernolvsis. reticulocytosis, abdominal pain, headache, nausea, vomiting, tiredness and priapism have been reported.

Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate. An impaired capacity to eliminate fat may lead to the fat overload syndrome as a result of overdosage, but also at recommended rates of infusion in association with a sudden change in the patient's clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. These changes are invariably reversible on discontinuation of the fat infusion If symptoms of overdose occur, the infusion should be slowed down or discontinued. In some rare serious cases, hemodialysis. haemofiltration or haemo-diafiltration may be necessary.

This parenteral nutrition is indicated for patients and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.

The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/l during infusion. The bag size, especially the volume and the quantitative composition, should be carefully chosen. These volumes should be adjusted according to the hydration and nutritional status of the children. One reconstituted bag is for single use. Disturbances of the electrolyte and fluid balance (e g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.

Special clinical monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.

This solution should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia or sepsis. If this solution is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory.

Parenteral nutritional preparations