Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1. Pharmacodynamic properties

Pharmacotherapeutic group : Solutions for parenteral nutrition/mixtures.
ATC code : B05 BA 10.
This is a ternary mixture enabling the nitrogen/energy balance to be maintained from the nitrogen source (L series amino acids) and energy in the form of glucose and essential fatty acids. In addition, this formulation contains electrolytes.

The amino acid solution contains 15 L series amino acids (including 8 essential amino acids), which are indispensable for protein synthesis.

Oliclinomel N4-550E,             9 6. 2015, RH             Page 9 sur 14 
The amino acids also represent an energy source, their oxidation resulting in excretion of nitrogen in the form of urea.

The amino acid profile is as follows :

• essential amino acids/total amino acids      : 40.5 %
• essential amino acids (g)/total nitrogen (g) : 2.5
• branched-chain amino acids/total amino acids : 19 %
The carbohydrate source is glucose (80 g/l).

The lipid emulsion is an association of refined olive oil and refined soya bean oil (ratio 80/20), with the following approximate distribution of fatty acids :

• 15 % saturated fatty acids (SFA)
• 65 % monounsaturated fatty acids (MUFA)
• 20 % polyunsaturated essential fatty acids (PUFA)

The phospholipid/triglyceride ratio is 0.06.
The moderate essential fatty acid (EFA) content improves the status of their upper derivatives while correcting essential fatty acid (EFA) deficiency.

Olive oil contains a significant amount of alpha tocopherol which, combined with a moderate polyunsaturated essential fatty acid (PUFA) intake, contributes to improve vitamin E status and reduce lipid peroxidation.

Pharmacokinetic Properties

5.2. Pharmacokinetic properties
The ingredients of the emulsion for infusion (amino acids, electrolytes, glucose, lipids) are distributed, metabolised and removed in the same way as if they had been administered individually.

The pharmacokinetic properties of the amino acids administered intravenously are principally the same as those of amino acids supplied by oral feeding. Amino acids from food proteins, however, first pass through the vena porta before reaching the systemic circulation.

The elimination rate of lipid emulsions depends on particle size. Small lipid particles appear to delay clearance whereas they increase lipolysis by lipoprotein lipase.

The size of the lipid particles in the emulsion contained in Oliclinomel is close to that of chylomicrons and this emulsion therefore has a similar elimination rate.