SmofKabiven/SmofKabiven Peripheral

Parenteral nutrition.

SmofKabiven: SmofKabiven consists of a three chamber bag system. Each bag contains the following partial volumes depending on the four pack sizes. (See Table 1.)

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This corresponds to the following total compositions: See Table 2.

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Corresponding to: See Table 3.

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SmofKabiven Peripheral: SmofKabiven Peripheral consists of a three chamber bag system. Each bag contains the following partial volumes depending on the three pack sizes. See Table 4.

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This corresponds to the following total compositions: See Table 5.

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Corresponding to: See Table 6.

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Pharmacotherapeutic group: Solutions for parenteral nutrition. ATC code: B05BA10.
Pharmacology: Pharmacodynamics: Lipid emulsion: The lipid emulsion of SmofKabiven is composed of Smoflipid and has a particle size and biological properties similar to those of endogenous chylomicrons. The constituents of SmofKabiven; soya-bean oil, medium-chain triglycerides, olive oil and fish oil have except for their energy contents, their own pharmacodynamics properties.
Soya-bean oil has a high content of essential fatty acids. The omega-6 fatty acid linoleic acid is the most abundant (approx. 55-60%). Alpha-linolenic acid, an omega-3 fatty acid, constitutes about 8%. This part of SmofKabiven provides the necessary amount of essential fatty acids. Medium-chain fatty acids are rapidly oxidized and provide the body with a form of immediately available energy.
Olive oil mainly provides energy in the form of mono-unsaturated fatty acids, which are much less prone to peroxidation than the corresponding amount of poly-unsaturated fatty acids.
Fish oil is characterised by a high content of eicosapentaenoic acid (EPA) and docosahexaenoicacid (DHA). DHA is an important structural component of cell membranes, whereas EPA is a precursor of eicosanoids as prostaglandins, thromboxanes and leucotrienes.
Two studies providing home parenteral nutrition in patients in need of long-term nutrition support have been performed. The primary objective in both studies was to show safety.
Efficacy was the secondary objective in one of the studies, which was done in paediatric patients. This study was stratified by age groups (1 month - <2 years, and 2-11 years respectively). Both studies showed that Smoflipid has the same safety profile as the comparator (Intralipid 20%). Efficacy in the paediatric study was measured by weight gain, height, body mass index, pre-albumin, retinol binding protein and fatty acid profile. There was no difference between the groups in any of the parameters except the fatty acid profile after 4 weeks treatment. The fatty acid profile in the Smoflipid patients revealed an increase in omega-3 fatty acids in plasma lipoproteins and red blood cells phospholipids and hence reflects the composition of the infused lipid emulsion.
Amino acids and electrolytes: The amino acids, constituents of protein in ordinary food, are utilized for tissue protein synthesis and any surplus is channeled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino acid infusion.
Glucose: Glucose should have no pharmacodynamics effects apart from contributing to maintain or replete the normal nutritional status.
Pharmacokinetics: Lipid emulsion: The individual triglycerides in Smoflipid have different clearance rate but Smoflipid as a mixture is eliminated faster than long chain triglycerides (LCT). Olive oil has the slowest clearance rate of the components (somewhat slower than LCT) and medium chain triglycerides (MCT) the fastest. Fish oil in a mixture with LCT has the same clearance rate as LCT alone.
Amino acids and electrolytes: The principal pharmacokinetic properties of the infused aminoacids and electrolytes are essentially the same as for amino acids and electrolytes supplied by ordinary food. However, the amino acids of dietary protein first enter the portal vein and then the systemic circulation, while intravenously infused amino acids reach the systemic circulation directly.
Glucose: The pharmacokinetic properties of infused glucose are essentially the same as those of glucose supplied by ordinary food.

Parenteral nutrition for adult patients and children aged 2 years and above (for SmofKabiven only) when oral or enteral nutrition is impossible, insufficient or contraindicated.

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 3.0 ml/kg bw/h (corresponding to 0.21 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 40 ml/kg bw/day. The recommended maximum daily dose of 40 ml/kg bw/day will provide 0.20 g nitrogen/kg bw/day (corresponding to 1.3 g amino acids/kg bw/day), 2.8 g glucose/kg bw/day, 1.1 g fat/kg bw/day and a total energy of 28 kcal/kg bw/day (corresponding to 22 kcal/kg bw/day of non-protein energy).
SmofKabiven: The dosage range of 13-31 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 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.
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 lipids 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 lipids/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 lipids/kg bw/day and a total energy of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).
Paediatric population: Children (2-11 years): Dosage: The dose up to 35 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients.
Infusion rate: The recommended maximum infusion rate is 2.4 ml/kg bw/h (corresponding to 0.12 g amino acids/kg/h, 0.30 g/glucose/kg/h and 0.09 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 14 hours 30 minutes, except in exceptional cases and with careful monitoring.
The recommended infusion period is 12-24 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 1.8 g amino acids/kg bw/day (corresponding to 0.28 g nitrogen/kg bw/day), 4.5 g glucose/kg bw/day, 1.33 g lipids/kg bw/day and a total energy content of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).
Adolescents (12-16/18 years): In adolescents, SmofKabiven can be used as in adults.
SmofKabiven Peripheral: The dosage range of 20 ml-40 ml SmofKabiven Peripheral/kg bw/day corresponds to 0.10-0.20 g nitrogen/kg bw/day (0.6-1.3 g amino acids/kg bw/day) and 14-28 kcal/kg bw/day of total energy (11-22 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.
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 3.0 ml/kg bw/h (corresponding to 0.21 g glucose, 0.10 g amino acids, and 0.08 g fat/kg bw/h).
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 40 ml/kg bw/day.
The recommended maximum daily dose of 40 ml/kg bw/day will provide 0.20 g nitrogen/kg bw/day (corresponding to 1.3 g amino acids/kg bw/day), 2.8 g glucose/kg bw/day, 1.1 g fat/kg bw/day and a total energy of 28 kcal/kg bw/day (corresponding to 22 kcal/kg bw/day of non-protein energy).
Method of Administration: Important: SmofKabiven/SmofKabiven Peripheral may only be mixed with other medicinal products for which compatibility has been documented.
SmofKabiven: 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.
SmofKabiven Peripheral: Intravenous use, infusion into a peripheral or central vein.
SmofKabiven Peripheral is available in three pack sizes intended for patients with 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 Peripheral) should be added to SmofKabiven Peripheral according to the patients need.
Pediatric patients: SmofKabiven Peripheral is not recommended for use in children.

Hypersensitivity to fish, egg, soya or peanut protein or to any of the active substances or excipients listed in Description.
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).
Infants and children under 2 years of age.

The capacity to eliminate lipids 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, see Adverse Reactions.
SmofKabiven/SmofKabiven Peripheral 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.
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/SmofKabiven Peripheral 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 or peripheral 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 lipids are 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 dyspnea) should lead to immediate interruption of the infusion.
The lipid content of SmofKabiven/SmofKabiven Peripheral may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before lipid has been adequately cleared from the bloodstream. Lipids are cleared after a lipid free interval 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 long-term intravenous nutrition. Amounts of zinc administered with SmofKabiven/SmofKabiven Peripheral 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/SmofKabiven Peripheral should not be given simultaneously with blood in the same infusion set due to the risk of pseudo-agglutination.
In patients with hyperglycaemia, administration of exogenous insulin might be necessary.
SmofKabiven: In adult malnourished hemodialysis patients, Intradialytic parenteral nutrition (IDPN) can be considered and is recommended by international guidelines (ESPEN Guideline). The usual dose rate limitations for SmofKabiven apply in this case, electrolyte should be closely monitored especially potassium and phosphate.
SmofKabiven Peripheral: Thrombophlebitis may occur if peripheral veins are used for infusions. The catheter insertion site should be evaluated daily for local signs of thrombophlebitis.
Use in Children: Due to composition of the amino acid solution in SmofKabiven/SmofKabiven Peripheral it is not suitable for the use in newborns or infants below 2 years of age. There is no clinical experience of the use of SmofKabiven/SmofKabiven Peripheral in children age 2 years to 16/18 years for SmofKabiven and age 2 years to 11 years for SmofKabiven Peripheral.

See Table 7.

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Should these side-effects occur the infusion of SmofKabiven/SmofKabiven Peripheral should be stopped or, if necessary, continued at a reduced dosage.

Do not store above 25°C. Do not freeze. Store in overpouch.
Shelf life of the medicinal product as packaged for sale: 2 years.
Shelf life after mixing: Chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 36 hours at 25°C. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.
Shelf life after mixing with additives: From a microbiological point of view, the product should be used immediately when additions have been made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hours at 2-8°C.

Parenteral Nutritional Products

V06DE - Amino acids/carbohydrates/minerals/vitamins, combinations ; Used as general nutrients.

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