8. SmofKabiven 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 soybean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions.
Cross allergic reaction has been observed between soybean 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.
g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion. SmofKabiven 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. 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 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 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. Paediatric population Due to composition of the amino acid solution in SmofKabiven 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 in children (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.
Soybean 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. 6 Fertility, pregnancy and lactation There are no data available on exposure of SmofKabiven 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 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 should be stopped or, if necessary, continued at a reduced dosage. Fat overload syndrome Impaired capacity to eliminate triglycerides can lead to “Fat overload syndrome” which may be caused by overdose.
Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the lipid metabolism may be affected by ongoing or previous illnesses. This syndrome may also […]