SMOFLIPID 20 % 100 ml/250 ml/500 ml emulsion

INSTRUCTIONS for medical use of the medicinal product Olimel N9E

Olimel N9E

Composition:

active substances: alanine; arginine; aspartic acid; glutamic acid; glycine; histidine; isoleucine; leucine; lysine acetate (equivalent to lysine); methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine; sodium acetate trihydrate; potassium chloride; magnesium chloride hexahydrate; sodium glycerophosphate, hydrated; glucose, monohydrate (equivalent to anhydrous glucose); calcium chloride, dihydrate; refined olive oil; refined soybean oil.

Pharmaceutical form

Emulsion for infusion.

Main physical and chemical properties

glucose solution with calcium and amino acid solution with electrolytes: clear, colorless or slightly yellow, practically free from particles;

lipid emulsion: homogeneous milky liquid.

Pharmacotherapeutic group

Solutions for parenteral nutrition. Combinations.

ATC code B05B A10.

Pharmacological properties

Pharmacodynamics

The content of nitrogen (L-amino acid series) and calories (glucose and triglycerides) in the Olimel N9E preparation makes it possible to maintain an adequate nitrogen/calorie ratio.

The preparation also contains electrolytes.

Pharmacokinetics

The ingredients of the Olimel N9E preparation (amino acids, electrolytes, glucose, and fats) are distributed, metabolized, and excreted by the same pathways as the individual components.

Clinical characteristics

Indications

For parenteral nutrition of adults and children over 2 years of age when oral or enteral nutrition is impossible, insufficient, or contraindicated.

Contraindications

Age under 2 years.

Hypersensitivity to egg proteins, soy, peanuts, or corn/corn products (see section "Special warnings and precautions for use"), or to any of the active substances or excipients.

Inborn errors of amino acid metabolism.

Expressed hyperlipidemia or severe lipid metabolism disorders characterized by hypertriglyceridemia.

Severe hyperglycemia.

Pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium, and/or phosphorus.

Interaction with other medicinal products and other forms of interaction

No interaction studies have been conducted.

Olimel N9E should not be administered simultaneously with blood through the same infusion system due to the possibility of pseudoagglutination.

Special warnings and precautions for use

Too rapid administration

Too rapid administration of any complete parenteral nutrition solution may lead to severe or fatal consequences.

Infusion and monitoring

Infusion should be stopped immediately if any symptoms of an allergic reaction appear (such as sweating, increased body temperature, chills, headache, skin rash, or shortness of breath).

Adverse reactions

Potential undesirable effects may occur as a result of incorrect use (e.g., overdose, too high infusion rate) (see sections "Special warnings and precautions for use" and "Overdose").

Dosage and administration

Dosage

Olimel N9E is contraindicated for use in children under 2 years of age due to the inappropriate composition and volume (see sections "Pharmacodynamics", "Pharmacokinetics", and "Special warnings and precautions for use").

Children over 2 years of age

No studies have been conducted in pediatric patients.

Overdose

In case of incorrect use (overdose and/or exceeding the recommended infusion rate), signs of hypervolemia and acidosis may appear.

Adverse reactions

Potential undesirable effects may occur as a result of incorrect use (e.g., overdose, too high infusion rate) (see sections "Special warnings and precautions for use" and "Overdose").

Shelf life

2 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Do not freeze. Store in a place inaccessible to children.

Incompatibility

Do not add other medicinal products or substances to any of the chambers of the bag or to the reconstituted emulsion without first ensuring their compatibility and stability of the resulting solution (in particular, the stability of the fat emulsion).

Release category

Prescription only.

Manufacturer

Baxter S.A. / Baxter SA.

Boulevard Rene Branquart 80, Lessines, 7860, Belgium / Boulevard Rene Branquart 80, Lessines, 7860, Belgium.