Pharmacotherapeutic group: Solutions for parenteral nutrition, combinations. ATC Code: B05BA10.
Pharmacology: Pharmacodynamics: OLIMEL's/PERIOLIMEL's content in nitrogen (L series amino acids) and energy (glucose and triglycerides) enables maintaining an adequate nitrogen/energy balance.
This formulation also contains electrolytes.
The lipid emulsion included in OLIMEL/PERIOLIMEL is an association of refined olive oil and refined soybean 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.
Olive oil contains significant amounts of alpha-tocopherol which, combined with a moderate PUFA intake, contribute to improved vitamin E status and the reduction of lipid peroxidation.
The amino acids solution contains 17 L-series amino acids (including 8 essential amino acids), which are required for protein synthesis.
Amino acids also represent an energy source. Their oxidation results in excretion of nitrogen in the form of urea.
The amino acids profile is as follows: Essential amino acids/total amino acids: 44.8 %.
Essential amino acids (g)/total nitrogen (g): 2.8 %.
Branched-chain amino acids/total amino acids: 18.3 %.
The carbohydrate source is glucose.
Pharmacokinetics: The ingredients of OLIMEL/PERIOLIMEL (amino acids, electrolytes, glucose and lipids) are distributed, metabolised and removed in the same way as if they had been administered individually.
Toxicology: Preclinical safety data: No preclinical studies with OLIMEL/PERIOLIMEL have been performed.
Preclinical toxicity studies performed using the lipid emulsion contained in OLIMEL/PERIOLIMEL have identified the changes, which are conventionally found with a high intake of a lipid emulsion: fatty liver, thrombocytopenia and elevated cholesterol.
Preclinical studies performed using the solutions of amino acids and glucose contained in OLIMEL/PERIOLIMEL of different qualitative compositions and concentrations have not, however, revealed any specific toxicity.