Glucose 19% + Vamin 18 Novum + Intralipid 20%

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 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.

Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg/hour. Amino acid dosage should not exceed 0.1 g/kg/hour. Fat dosage should not provide more than 0.15 g/kg/hour. The infusion rate should not exceed 2.6 ml/kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.1g fat/kg). The recommended infusion period is 12-24 hours. This parenteral nutrition is recommended to be infused only into a central vein. The infusion may be continued for as long as required by the patient’s clinical condition.

• 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

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.

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

Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate. If symptoms of overdose occur, the infusion should be slowed down or discontinued. Additionally, an overdose might cause fluid overload, electrolyte imbalances, hyperglycemia, and hyperosmolality. In some rare serious cases, haemodialysis, haemofiltration or haemo diafiltration may be necessary.

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