The dosage range of 13 ml – 31 ml SmofKabiven Electrolyte Free/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 non-protein energy). This covers the need of the majority of the patients. In obese patients the dose should be based on the estimated ideal weight.
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.
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).
Intravenous use, infusion into a central vein.
The five different package sizes of SmofKabiven Electrolyte Free are intended for patients with high, moderately increased or basal nutritional requirements. To provide total parenteral nutrition, trace elements, electrolytes and vitamins should be added to SmofKabiven Electrolyte Free according to the patients need.
- Posology and Method of Administration
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, see section 4.4.
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
SmPC 11-385, 2011-12-14 and 12-397, 2012-06-04 MRP approved 2012-07-03 2(11)
- 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
- General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency
- Hemophagocytotic syndrome
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.
SmofKabiven Electrolyte Free is not recommended for use in children, see section
- 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)
- Special warnings and precautions for use
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 Electrolyte Free 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 well-controlled infusion, if possible by using a volumetric pump.
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.
SmofKabiven Electrolyte Free is produced almost electrolyte free for patients with special and/or limited electrolyte requirements. Sodium, potassium, calcium, magnesium and additional amounts of phosphate should be added governed by the clinical condition of the patient and by frequent monitoring of serum levels.
In patients with renal insufficiency, the phosphate intake should be carefully controlled to prevent hyperphosphatemia.
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 Electrolyte Free 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.
SmPC 11-385, 2011-12-14 and 12-397, 2012-06-04 MRP approved 2012-07-03 4(11)
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 long-term intravenous nutrition.
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 Electrolyte Free 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 Electrolyte Free 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 Electrolyte Free in children (age 2 years to 11 years).
4.5 Interaction with other medicinal products and other forms of interaction
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 Electrolyte Free is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.
There are no data available on exposure of SmofKabiven Electrolyte Free 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 Electrolyte Free should only be given to pregnant and breast-feeding women after careful consideration.
- Effects on ability to drive and use machines
Not relevant.
SmPC
