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 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.
Always consult a registered doctor before taking any medicine. This information is for general knowledge only.
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.
Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. Severe hyperlipaemia Severe liver insufficiency Severe blood coagulation disorders Inborn errors of amino acid metabolism Severe renal insufficiency without access to haemofiltration or dialysis Acute shock Hyperglycemia, which requires more than 6 units insulin/h Pathologically elevated serum levels of any of the included electrolytes. General contra-indications to infusion therapy acute pulmonary oedema, hyper hydration and decompensated cardiac insufficiency and hypotonic dehydration Haemophagocytotic syndrome Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma) Infants under 2 years of age
The soybean oil present in this intravenous preparation has vitamin K1. Vitamin K1 can reverse the anticoagulant activity of coumarin and coumarin derivatives, including warfarin, which works by blocking recycling of vitamin K1. Monitor laboratory parameters for anticoagulant activity in patients who are on both this intravenous preparation and coumarin or coumarin derivatives.
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.