KABIVEN PERIPHERAL

The ability to eliminate fat and metabolise glucose should govern the dosage and infusion rate. 4 “Special warning and precautions for use”. Posology The dose should be individualised and the choice of bag size should be made with regard to the patient’s clinical condition, body weight and nutritional requirements.

g. nutritional state and degree of catabolic stress). /day in the normal nutritional state. /day). 0 g for fat. /day. In obese patients the dose should be based on the estimated ideal weight. Kabiven Peripheral 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. 0 g amino acid/kg body weigh/day) and a total energy of 20-30 kcal body weight/day corresponds to approx.

/day. Paediatric population The ability to metabolise individual nutrients must determine the dosage. e. 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 Kabiven peripheral is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential. /h. w. /h. /h. 13 g fat per kg body weight). The recommended infusion period for individual bags of Kabiven Peripheral is 12-24 hours.

/day. /day). The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. Method of administration Intravenous infusion into a peripheral or central vein. Infusion may be continued for as long as required by the patient’s clinical condition.

In order to minimise the risk of thrombophlebitis for peripheral application, daily rotation of infusion site is recommended.

g. anaphylactic reaction, skin rash, urticaria) Investigations Increase in plasma levels of liver enzymes Nervous system disorders Headache Reproductive system and breast disorders Priapism Vascular disorders Thrombophlebitis Hypotension, hypertension General disorders and administration site conditions Rise in body temperature Chills, tiredness As with all hypertonic solutions for infusion, thrombophlebitis may occur if peripheral veins are used.

Fat overload syndrome An impaired capacity to eliminate fat may lead to the fat overload syndrome. This may occur as a result of overdosage, but also at recommended rates of infusion, in association with a sudden change in the patient’s clinical condition resulting in severe renal or hepatic impairment.

The fat overload syndrome is characterised by hyperlipidaemia, fever, hepato- splenomegaly, anaemia, leucopenia, thrombocytopenia, coagulopathies and coma. These changes are invariably reversible on discontinuation of the fat infusion.

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 national reporting system.

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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, specially 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.

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. Kabiven Peripheral should be given with caution in conditions of impaired lipid metabolism which may occur in patients with renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridaemia) or sepsis.

If Kabiven Peripheral is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory. Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests should be regularly monitored.

Blood cell count and coagulation should be monitored when fat is given for a longer period. In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphataemia and hyperkalemia.

The amount of supplemental electrolytes should be determined by regular monitoring taking into consideration the clinical condition of the patient. This emulsion is free of vitamins and trace-elements. The addition of trace elements and vitamins is always required.

1. 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.

g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma) Infants and children under 2 years of age.