SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE

Posology The appearance of the product after mixing the 3 chambers is a white emulsion. The patient’s ability to eliminate lipids and metabolise nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate, see section

8. SmofKabiven extra Nitrogen 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 lipids are given for a longer period. SmofKabiven extra Nitrogen 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 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. g. bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before lipids have been adequately cleared from the bloodstream.

Lipids are cleared after a lipid-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 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 extra Nitrogen 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.

SmofKabiven extra Nitrogen Electrolyte free is a preparation of complex composition. 2). Paediatric population Due to composition of the amino acid solution in SmofKabiven extra Nitrogen Electrolyte free it is not suitable for the use in new-borns or infants below 2 years of age.

There is no clinical experience of the use of SmofKabiven extra Nitrogen Electrolyte free in children and adolescents (age 2 to 16/18 years). 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 extra Nitrogen Electrolyte free is so low that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.

6 Fertility, pregnancy and lactation There are no data available on exposure of SmofKabiven extra Nitrogen 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 extra Nitrogen Electrolyte free should only be given to pregnant and breast-feeding women after careful consideration. 7 Effects on ability to drive and use machines Not relevant. g. anaphylactic or anaphylactoid reactions, skin rash, urticaria, flush, headache), heat or cold sensation, paleness, cyanosis, pain in the neck, back, bones, chest and loins.

Should these side-effects occur the infusion of SmofKabiven extra Nitrogen Electrolyte free should be stopped or, if necessary, continued at a reduced dosage. Fat overload syndrome Impaired capacity to eliminate triglycerides can lead to “Fat […]

4. The dose should be individualised to the patient’s clinical condition, body weight (bw), nutritional and energy requirements, adjusting dosage based upon additional oral/enteral intake. g. nutritional state and degree of catabolic stress or anabolism).

9 g amino acids/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. 6 g amino acids/kg bw/day). g. burns or marked anabolism) the nitrogen need may be even higher. 0 g amino acids/kg bw/day) and 12-28 kcal/kg bw/day of total energy (8-19 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. 15 g/kg bw/h. 04 g lipids/kg bw/h). The recommended infusion period is 14-24 hours. 09 g lipids/kg/h). The usual infusion time for use in IDPN is 3-5 hours, depending on the patient’s needs and the scheduled duration of the renal replacement therapy session.

The maximum recommended daily dose remains unchanged.

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 31 ml/kg bw/day. 9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy).

Paediatric population Children (2-11 years) Dosage:

The dose up to 31 ml/kg bw/day should be regularly adjusted to the requirements of the paediatric patient that varies more than in adult patients. 05 g lipids/kg/h). At the recommended maximum infusion rate, do not use an infusion period longer than 17 hours, 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 31 ml/kg bw/day. 9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy).

Adolescents (12-16/18 years) In adolescents, SmofKabiven extra Nitrogen Electrolyte free can be used as in adults. Method of administration Intravenous use, infusion into a central vein. The five different package sizes of SmofKabiven extra Nitrogen 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 extra Nitrogen Electrolyte free according to the patients need. 6. g. 4 Special warnings and precautions for use 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. 8. SmofKabiven extra Nitrogen 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 […]

g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration and hyperosmolar coma) - Neonates and infants under 2 years of age