Kabiven Central 1026 ml/bag

INDICATIONS

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

DOSAGE

The dose should be individualized and the choice of bag size should be made with regard to the patients clinical condition, body weight and nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.Adult patients: The nitrogen requirements for maintenance of body protein mass depend on the patients condition (e.q. nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.30g nitrogen/kg/day (1.0-2.0 g amino acid/kg/day). The corresponding commonly accepted requirements are 2.0-6.0 g for glucose and 1.0-2.0g for fat. The dose range of 0.10-0.20 g nitrogen/kg/day (0.7-1.3 g amino acid/kg/day) which covers the need of the majority of the patients. This corresponds to 19 ml-38 ml/kg/day. For a 70-kg-patient this is equivalent to 1330 ml-2660 ml of this solution per day. The total energy requirement depends on the patient's clinical condition and is most often between 25 - 35 kcal/kg/ day. In obese patients the dose should be based on the estimated ideal weight. This solution is produced in four sizes intended for patients with high, moderately increased, basal, or low nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.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 i.e. 12.5-25 ml/kg (corresponding to 0.49-0.98 g fat/kg/day,0.41-0.83 g amino acids/kg/day and 1.2-2.4 g glucose/kg/day) and increased by10-15ml/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 parenteral nutrition is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.

SIDE EFFECTS

Intralipid 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. As with all hypertonic solutions for infusion, thrombophlebitis may occur if peripheral veins are used. Reports of other undesirable effects in conjunction with Intralipid infusions are extremely rare; less than one adverse event per million infusions. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haemolysis, reticulocytosis, abdominal pain, headache, tiredness and priapism have been reported. Fat overload syndrome: An impaired capacity to eliminate Intralipid (the fat component in this parenteral nutrition) may lead to the fat overload syndrome as a result of over-dosage, but also at recommended rates of infusion in association with a sudden change in the patients clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipidaemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. All symptoms are usually reversible if the infusion is discontinued.

PRECAUTIONS & WARNINGS

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.

THERAPEUTIC CLASS

Parenteral nutritional preparations

STORAGE CONDITIONS

Store at 25°C. Do not freeze. It is recommended to store.