Combiflex Lipid Central/Combiflex Lipid Peri Special Precautions

The ability to eliminate lipid should be monitored. It is recommended that this is done by measuring serum triglycerides after a lipid-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/L during infusion. The bag size, especially the volume and the quantitative composition, should be carefully chosen. These volumes should be adjusted according to the hydration and nutritional status of the children. One reconstituted bag is for single use. 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. 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. Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridaemia) or sepsis. If Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory. Serum glucose, electrolytes and osmolality as well as fluid balance, acid-base status and liver enzyme tests should be regularly monitored. Blood cell count and coagulation should be monitored when lipid is given for a longer period. In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphataemia and hyperkalemia. The amount of supplemental electrolytes should be determined by regular monitoring taking into consideration the clinical condition of the patient. This emulsion is free of vitamins and trace-elements. The addition of trace elements and vitamins is always required. Parenteral nutrition should be given with caution to patients with metabolic acidosis (e.g. lactic acidosis), increased serum osmolarity or those in need of fluid resuscitation. Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) should be given with caution to patients with a tendency towards electrolyte retention. Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnea) necessitates immediate interruption of the infusion. The lipid content of Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) 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. Lipid is cleared after a lipid-free interval of 5-6 hours in most patients. This medicinal product contains soy bean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soy-bean and peanut.
Intravenous infusion of amino acids may be accompanied by increased urinary excretion of trace elements, particularly zinc. Additional supplements of trace elements may be required in patients requiring long-term intravenous nutrition. In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure. In addition, decreases in the serum concentrations of potassium, phosphorus, magnesium and water soluble vitamins may occur within 24 to 48 hours. Careful and slow initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.
Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) should not be given simultaneously with blood or blood products in the same infusion set. In patients with hyperglycemia, administration of exogenous insulin might be necessary.
Effects on Ability to Drive and Use Machine: Not applicable.
Combiflex Lipid Peri: Peripheral Infusion: As with all hypertonic solutions, thrombophlebitis may occur if peripheral veins are used for infusions. Several factors contribute to the incidence of thrombophlebitis. These include the type of cannula used and its diameter and length, the duration of infusion, pH and osmolality of infusates, infection and the number of manipulations. It is recommended that venous access sites for Total Parenteral Nutrition should not be used for other intravenous additive or solutions.