Amino Acids + Lipids + Glucose + Electrolytes

Parenteral nutrition for adult patients and paediatric patients aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.

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 SMOFlipid, soya oil, medium chain triglycerides, olive oil and fish oil, have except for their energy contents individual pharmacodynamic properties. Soya oil has a high content of essential fatty acids (linoleic acid and alpha-linolenic acid). The omega-6 fatty acid linoleic acid is the most abundant. Medium-chain fatty acids are rapidly oxidised. Olive oil mainly provides energy in the form of mono-unsaturated fatty acids. Fish oil is characterised by a high content of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an important structural component of cell membranes, whereas EPA is a precursor of eicosanoids as prostaglandins, thromboxanes and leukotrienes.

Amino acids and electrolytes: The amino acids, constituents of protein in ordinary food, are utilised for tissue protein synthesis and any surplus is channelled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino acid infusion.

Glucose: Glucose should have no pharmacodynamic effects apart from contributing to maintain or replete the normal nutritional status.

Adults: 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.

Dosage: 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 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 body 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).

Children (2-11 years): 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).

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 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.

• Hypersensitivity to fish-, egg-, soya- or peanut protein or corn (maize) and corn products or to any of the active substances or excipients
• Severe hyperlipidaemia
• 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
• Haemophagocytotic 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

As with all parenteral nutrition products, SmofKabiven is exempt from pregnancy categorisation. There are no adequate and well-controlled studies in pregnant women with SmofKabiven or its individual components; therefore, the safety of SmofKabiven in pregnant women is not known.

It is not known whether SmofKabiven can enter maternal milk. As zinc is excreted in milk, there is a theoretical risk of zinc-induced copper deficiency in the infant at high doses of SmofKabiven. SmofKabiven should be used during lactation only if clearly needed.

Parenteral nutritional preparations

Store below 25°C. Do not freeze. Store in overpouch.