Soya bean oil, medium chain triglycerides, glycerol, egg lecithin, all-rac-α-tocopherol, sodium oleate, linoleic acid, α-linolenic acid.
Each 1,000 mL of emulsion contains soya bean oil 100 g, medium-chain triglycerides 100 g. It also contains glycerol, egg lecithin, all-rac-α-tocopherol, sodium oleate and water for injections.
Content of Essential Fatty Acids: Linoleic acid: 48-58 g/L; α-linolenic acid: 5-11 g/L.
Caloric Value: 7,990 kJ/L (1,908 kCal/L). Theoretical Osmolarity: 380 mOsmol/L. Titration Acidity or Alkalinity (to pH 7.4): <0.5 mmol/L. pH: 6.5-8.5.
Calorie supply including a readily metabolisable fat component (MCT); supply of essential fatty acids and fluid in the setting of total parenteral nutrition.
As a rule, depending on calorie requirements:
Adults and School-Age Children: 1-2 g fat/kg body weight/day corresponding to 5-10 mL Lipofundin MCT/LCT 20% per kg body weight per day.
Neonates: 2-3 (maximum 4) g lipid/kg body weight/day, corresponding to 10-15 (maximum 20) mL Lipofundin MCT/LCT 20% per kg body weight per day.
The ability to eliminate triglycerides and lipids is not fully developed, particularly in the case of premature and hypotrophic neonates, hence to dosage limits should not be exploited completely and triglyceride and fatty acids should be monitored very carefully. There must not be any hyperlipaemia at the end of the interval between the daily infusions.
Infants and Pre-School Children: 1-3 g lipid/kg body weight/day, corresponding to 5-15 mL Lipofundin MCT/LCT 20% per kg body weight per day.
Infusion Rate: The infusion rate should be as low as possible. The infusion rate during the first 15 min of the infusion should not exceed 0.05-0.1 g lipid/kg body weight/hr, corresponding to 0.25-0.5ml of emulsion per kg body weight per hour.
Maximum Infusion Rate: Up to 0.15 g lipid/kg body weight/hr, corresponding to up to 0.75 mL Lipofundin MCT/LCT 20% per kg body weight per hour.
Accordingly, the drop rate should not exceed 0.25 drops/kg body weight/min.
This means that for a patient weighing 70 kg, the maximum infusion rate may be approximately 50 mL/hr or 18 drops/min.
The infusion rate should be reduced in malnourished patients and in children.
It is recommended that the infusion rate be so chosen that the planned daily dose can be administered within 24 hrs or not <16 hrs/day.
Duration of Use: The duration of administration of the fat emulsion as part of a complete parenteral nutrition is generally 1-2 weeks. If parenteral nutrition with lipid emulsions is further indicated, the emulsion can be administered over longer periods provided appropriate monitoring is employed.
Administration: As IV infusion.
Lipid emulsions are suitable for peripheral venous administration and can also be administered separately via peripheral veins as part of total parenteral nutrition.
If infusion sets with in-line filters are used, they must be lipid-permeable.
When lipid emulsions are to be simultaneously infused with amino acid and carbohydrate solutions, the Y- or the bypass connector should be placed as close to the patient as possible. It should be made sure that solutions to be infused together with Lipofundin MCT/LCT 20% through the same tubing are compatible with the fat emulsion.
When administering the fat emulsion from flexible bags, the air vent of the infusion set must be closed.
Only infuse emulsions having room temperature.
Symptoms: Overdose can cause an overload syndrome showing the following symptoms: Fever, headache, abdominal pain, fatigue, hyperlipaemia, hepatomegaly with or without jaundice, splenomegaly, pathological liver function tests, anaemia, reduction of platelet counts, reduction of leucocyte counts, haemorrhage and tendency to haemorrhage, alterations or reductions in blood coagulation factors (as indicated by pathological values of bleeding time, coagulation time, prothrombin time, etc).
Treatment: Immediate cessation of infusion. Further therapy is determined according to the individual symptoms and their severity; in some circumstances, it may be necessary to transfuse blood or blood components.
Lipofundin MCT/LCT 20% must not be administered in the following conditions: Severe blood coagulation disorders, states of shock and collapse, acute thromboembolism, fat embolism, severe septicaemia accompanied by acidosis and hypoxia, acute phases of myocardial infarction and stroke, ketoacidotic coma, decompensated diabetic metabolism or unstable metabolism.
The administration of Lipofundin MCT/LCT 20% is also contraindicated if serum triglycerides accumulate in the following conditions: Disorders of lipid metabolism, liver diseases, disorders of the reticuloendothelial system, haemorrhagic necrotising pancreatitis.
General contraindications for parenteral nutrition: Acidoses of various origin, uncorrected disturbances of the electrolyte and fluid balances (eg, hypotonic dehydration, hypokalaemia, hyperhydration), intrahepatic cholestasis.
Hypersensitivity reactions to one of the ingredients of Lipofundin MCT/LCT 20%, (eg, traces of protein in soya oil or egg lecithin), are extremely rare, however, these cannot be totally excluded for sensitised patients. Therefore, particular caution should be observed when Lipofundin MCT/LCT 20% (or fat emulsions in general) are to be administered to such patients.
If fat is to be administered in high doses every day, there should be controls of serum triglycerides and, if necessary, of blood sugar, acid-base and electrolyte status after the 1st day of infusion and then at suitable intervals.
The water balance and/or body weight should be monitored daily.
Because alterations in the blood cell counts may be symptoms of overdose, monitoring of the blood cell counts is advisable.
In the case of patients suspected to have disturbances of lipid metabolism, fasting hyperlipaemia should be excluded by determination of the serum triglyceride concentration. If during infusion the serum triglyceride concentrations exceed 3 mmol/L in adults and 1.7 mmol/L in children, the infusion rate must be reduced or the infusion must be stopped. Serum triglyceride concentrations exceeding above values 12 hrs after the lipid infusion has been stopped also indicates disturbance of lipid metabolism.
Fat administration should also be interrupted if there is a marked increase of the blood glucose concentration during fat infusion. Using fat emulsions as the only calorie source may provoke metabolic acidosis. Simultaneous carbohydrate infusions will prevent those complications. Therefore, fat infusions should always be accompanied by infusions of sufficient amounts of carbohydrate-containing solutions.
Vitamin E may have an influence on the effect of vitamin K in the synthesis of coagulation factors. Therefore, in patients receiving oral anticoagulants and suspected to have vitamin K deficiency, monitoring of the coagulation status is recommended.
The safety of Lipofundin MCT/LCT 20% during pregnancy and lactation has not been assessed, but its use during these periods is not considered to constitute a hazard. Nevertheless, medicines should not be used in pregnancy, especially during the 1st trimester, unless the expected benefit is thought to outweigh any possible risk to the foetus.
In very rare cases there can be acute reactions eg, dyspnoea, cyanosis, allergic reactions, hyperlipaemia, marked hyperglycaemia, hypercoagulability, nausea, vomiting, headache, flush, hyperthermia, hypertension or hypotension, sweating, shivering, drowsiness, chest and back pain during the intravenous infusion of lipids. The infusion should be stopped in such cases. When the symptoms have disappeared and elevated serum triglyceride concentrations (or lipaemic serum turbidity) have normalised, it is generally possible to recommence the infusion at a lower flow rate and/or dose. In such cases the patients should be carefully monitored, particularly in the initial stages, and the serum triglyceride concentrations (serum turbidity) should be controlled at short intervals.
In the case of patients suspected to have disturbances of lipid metabolism, fasting hyperlipaemia (serum triglyceride concentrations above 3 mmol/L in adults and above 1.7 mmol/L in children) should be excluded before the commencement of infusion. In the presence of fasting lipaemia, the further administration of lipid emulsions is contraindicated.
Hyperlipaemia (serum triglyceride concentrations above 3 mmol/L in adults and above 1.7 mmol/L in children) 12 hrs after the lipid infusion has been stopped also indicates disturbance of lipid metabolism.
Note: Patients are advised to inform the physician or pharmacist of any adverse effect they experience in connection with the administration of Lipofundin MCT/LCT 20%.
Interactions with other medicaments are not known so far.
Lipofundin MCT/LCT 20% must not be used as vehicle solutions for electrolyte concentrates or other medicaments. Uncontrolled mixing with other infusion solutions should also be avoided because adequate stability of the emulsion would no longer be guaranteed.
Combined regimes are only to be used for parenteral nutrition after their pharmaceutical compatibility has been controlled and guaranteed.
Admixture of alcohol containing injections or infusion solutions must be strictly avoided.
B05BA02 - fat emulsions ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.