Special Warning : אזהרת שימוש

4.4     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. An overdose may lead to fat overload syndrome, see section 4.8.

SmofKabiven Extra Nitrogen 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.


Page 5 of 15
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 Extra Nitrogen 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 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 dyspnoea) should lead to immediate interruption of the infusion.

The lipid content of SmofKabiven Extra Nitrogen may interfere with certain laboratory measurements (e.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. Amounts of zinc administered with SmofKabiven Extra Nitrogen 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 Extra Nitrogen should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.

Page 6 of 15
In patients with hyperglycaemia, administration of exogenous insulin might be necessary.

SmofKabiven Extra Nitrogen is a preparation of complex composition. It is, therefore, strongly advisable not to add other solutions if compatibility is not proven (see section 6.2).

Paediatric population
Due to composition of the amino acid solution in SmofKabiven Extra Nitrogen 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 in children and adolescents (age 2 to 16/18 years).

Effects on Driving

4.7    Effects on ability to drive and use machines
Not relevant.