Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1     Pharmacodynamic properties

Pharmacotherapeutic group:      Solutions for parenteral nutrition, fat emulsions ATC code:                       B05B A02

Lipofundin MCT/LCT 10% provides a source of energy and essential (polyunsaturated) fatty acids for the patient requiring parenteral nutrition. Medium-chain triglycerides are cleared from the bloodstream at a faster rate and are oxidised more completely for energy production than long-chain triglycerides. For that reason they serve as preferential fuel for the body, especially in conditions where the oxidation of long-chain triglycerides is impaired, eg due to carnitine deficiency (EFAD) or diminished carnitine palmitoyltransferase activity, resp.

The polyunsaturated fatty acids, which are only provided by long-chain triglycerides, prevent the biochemical disorders of essential fatty acid deficiency (EFAD), and correct the clinical manifestations of the EFAD syndrome

Pharmacokinetic Properties

5.2.    Pharmacokinetic properties

Because of the i.v. administration of Lipofundin MCT/LCT 10%, no data on absorption are provided; for the same reason, the bio-availability is 100 per cent.

The maximum serum triglyceride concentrations during infusion of Lipofundin MCT/LCT 10% mainly depend on the actual dose and infusion rate as well as on the patient's individual metabolic status and other patient-related factors, e.g. the fasting triglyceride level. In general, however, serum triglyceride concentrations will not exceed 5µmol/l as long as recommended doses and all other directions for use are observed.

The plasma half life time of triglycerides infused in the form of Lipofundin MCT/LCT 10% is approx. 9 minutes. Although the affinity of long-chain fatty acids to albumin is somewhat greater than that of medium-chain fatty acids, albumin binding of both types of fatty acids is virtually complete, provided the recommended doses are not exceeded. Therefore, medium- and long-chain fatty acids do not pass over into the cerebrospinal fluid. No data are presently available as to passage across the placental barrier and into breastmilk.

Triglycerides and free fatty acids are not excreted via the kidneys. In view of the intended nutritive effect of Lipofundin MCT/LCT 10%, such excretion is not even desirable. Poisoning requiring rapid elimination of the toxic agent is not to be expected with Lipofundin MCT/LCT 10% because this product only contains physiological nutrient substances.