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Pharmacotherapeutic group: Solutions for parenteral nutrition/combination. ATC Code: B05 BA10.
Pharmacology: Pharmacodynamics: The content of nitrogen (20 L-series amino acids, including 8 essential amino acids) in Numeta and energy (glucose and triglycerides) enables maintenance of an adequate nitrogen/energy balance. Nitrogen and energy are required for normal functioning of all cells in the body, and are important for protein synthesis, growth, wound healing, immune function, muscle function, and many other cellular activities.
This formulation also contains electrolytes.
The amino acids profile is as follows: Essential amino acids/total amino acids: 47.5%; Branched-chain amino acids/total amino acids: 24.0%.
The lipid emulsion included in Numeta is a mixture of refined olive oil and refined soybean oil (ratio 80/20 approximately), with the following relative distribution of fatty acids: 15% saturated fatty acids (SFA); 65% monounsaturated fatty acids (MUFA); 20% polyunsaturated 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 EFA deficiency.
Olive oil contains significant amounts of alpha-tocopherol which, when combined with a moderate PUFA intake, contributes to vitamin E status and is important for limiting lipid peroxidation.
The carbohydrate source is glucose. Glucose is a primary source of energy in the body.
Pharmacokinetics: The ingredients of the emulsion for infusion (amino acids, electrolytes, glucose and lipids) are distributed, metabolized and eliminated in the same way as if they had been administered individually. The product is given intravenously and is thus 100% bioavailable and the constituents are distributed to and metabolized by all cells in the body.
Toxicology: Preclinical safety data: Preclinical studies performed on the components of the triple chamber bag have revealed no additional risks to those already mentioned in other sections of the SmPC.
Animal studies with Numeta (double or triple chamber combinations) have not been conducted.
