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986 ml 1477 ml 1970 ml 2463 ml
The appearance of the product after mixing the 3 chambers is a white emulsion.
The patient’s ability to eliminate fat and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate.
The dose should be individualised with regard to the patient’s clinical condition and body weight (bw).
The nitrogen requirements for maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress or anabolism).
The requirements are 0.10-0.15 g nitrogen/kg bw/day (0.6-0.9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.25 g nitrogen/kg bw/day (0.9-1.6 g amino acids/kg bw/day). In some very special conditions (e.g. burns or marked anabolism) the nitrogen need may be even higher.
The dosage range of 13 ml – 31 ml SmofKabiven/kg bw/day corresponds to 0.10-0.25 g nitrogen/kg bw/day (0.6-1.6 g amino acids/kg bw/day) and 14-35 kcal/kg bw/day of total energy (12-27 kcal/kg bw/day of nonprotein energy). This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight.
Infusion rate: The maximum infusion rate for glucose is 0.25 g/kg bw/h, for amino acid 0.1 g/kg bw/h, and for fat 0.15 g/kg bw/h.
The infusion rate should not exceed 2.0 ml/kg bw/h (corresponding to 0.25 g glucose, 0.10 g amino acids, and 0.08 g fat/kg bw/h). The recommended infusion period is 14-24 hours.
Maximum daily dose: The maximum daily dose varies with the clinical condition of the patient and may even change from day to day. The recommended maximum daily dose is 35 ml/kg bw/day.
The recommended maximum daily dose of 35 ml/kg bw/day will provide 0.28 g nitrogen/kg bw/day (corresponding to 1.8 g amino acids/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g fat/kg bw/day and a total energy of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).
Method of administration: Intravenous use, infusion into a central vein.
The four different package sizes of SmofKabiven are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, vitamins and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven) should be added to SmofKabiven according to the patients need.
Pediatric patients: SmofKabiven is not recommended for use in children.
Parenteral nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.
– Hypersensitivity to fish-, egg, soya- or peanut protein or to any of the active substances or excipients
– Severe hyperlipidemia
– Severe liver insufficiency
– Severe blood coagulation disorders
– Congenital errors of amino acid metabolism
– Severe renal insufficiency without access to hemofiltration or dialysis
– Acute shock
– Uncontrolled hyperglycaemia
– Pathologically elevated serum levels of any of the included electrolytes
– General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency
– Hemophagocytotic syndrome
– Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma)
The capacity to eliminate fat is individual and should therefore be monitored according to the routines of the clinician. This is in general done by checking the triglyceride levels. The concentration of triglycerides in serum should not exceed 4 mmol/l during infusion. An overdose may lead to fat overload syndrome.
SmofKabiven should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis.
This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.
To avoid risks associated with too rapid infusion rates, it is recommended to use a continuous and wellcontrolled infusion, if possible by using a volumetric pump.
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.
SmofKabiven should be given with caution to patients with a tendency towards electrolyte retention. 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.
Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests should be 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 hyperphosphatemia and hyperkalaemia.
The amount of individual electrolytes to be added is governed by the clinical condition of the patient and by frequent monitoring of serum levels.
Parenteral nutrition should be given with caution in lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
The fat content of SmofKabiven may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before fat has been adequately cleared from the bloodstream. Fat is cleared after a fat-free interval of 5-6 hours in most patients.
Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements, in particular copper and zinc. This should be considered in the dosing of trace elements, especially during longterm intravenous nutrition. Amounts of zinc administered with SmofKabiven should be taken into account.
In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphorus, magnesium and water soluble vitamins. These changes can occur within 24 to 48 hours,
therefore careful and slow initiation of parenteral nutrition is recommended in this patient group, together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.
SmofKabiven should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.
In patients with hyperglycaemia, administration of exogenous insulin might be necessary.
Due to composition of the amino acid solution in SmofKabiven it is not suitable for the use in new-borns or infants below 2 years of age. There is at present no clinical experience of the use of SmofKabiven in children (age 2 years to 11 years).
Common: Slight increase in body temperature.
See prescribing information for full details.
Some medicinal products, like insulin, may interfere with the body’s lipase system. This kind of interaction seems, however, to be of limited clinical importance.
Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation. This may result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance.
Soya-bean oil has a natural content of vitamin K1. However, the concentration in SmofKabiven is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.
Pregnancy and Lactation
There are no data available on exposure of SmofKabiven in pregnant or breast-feeding women. There are no studies available on reproductive toxicity in animals. Parenteral nutrition may become necessary during pregnancy and lactation. SmofKabiven should only be given to pregnant and breast-feeding women after careful consideration.
If symptoms of overdose of fat or amino acids occur, the infusion should be slowed down or discontinued.
There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately.
If hyperglycaemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate.
Additionally, overdose might cause fluid overload, electrolyte imbalances and hyperosmolality.
In some rare serious cases, haemodialysis, haemofiltration or haemo-diafiltration may be considered.