SMOFlipid emulsion for infusion 20% 100ml vials, 10pcs

Composition

Active ingredients:

soybean oil (refined) 60 g,

medium-chain triglycerides 60 g,

olive oil (refined) 50 g,

purified fish oil 30 g

Pharmacological action

SMOFlipid-replenishes the deficiency of essential fatty acids, replenishes the lack of energy substrates in the body.

Pharmacodynamics

SMOFlipid is identical in particle size and biological properties to endogenous chylomicrons. The components of the drug — soy oil, medium-chain triglycerides, olive oil and fish oil-in addition to differences in composition and energy value, have their own pharmacodynamic properties.

Soy oil contains a large amount of essential fatty acids. It is most rich in linoleic acid (approximately 55-60%), which is an omega-6 fatty acid. 8% of the soybean oil composition is represented by alpha-linolenic acid, which is an omega-3 fatty acid. This part of the drug provides the necessary amount of essential fatty acids.

Medium-chain fatty acids provide the body with readily available energy due to their ability to oxidize rapidly.

Olive oil supplies energy in the form of monounsaturated fatty acids, which are much less susceptible to oxidation compared to the corresponding amount of PUFA.

Fish oil is characterized by a high content of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids. DHA is an important structural component of cell membranes, and EPA is a precursor to eicosanoids such as PG, thromboxanes, and LT.

Vitamin E protects unsaturated fatty acids from peroxidation.

Pharmacokinetics

Different triglycerides in the composition of SMOFlipid have different clearance rates, but SMOFlipid on average (as a mixture) is eliminated faster than long chain triglycerides (LCT). Olive oil has the lowest clearance of all components (slightly lower than LCT), while Medium chain triglycerides (MCTs) have the highest clearance. Fish oil in the LCT mixture has the same clearance as pure LCTs.

Indications

Complete or partial parenteral nutrition as a source of energy and essential fatty acids, including u-3 fatty acids, when oral or enteral nutrition is impossible, insufficient or contraindicated; prevention and treatment of insufficiency (deficiency) of essential fatty acids, including w-3 fatty acids.

Contraindications

• hypersensitivity to proteins like fish, eggs, soy, peanuts or components of the drug;
• severe hyperlipidemia;
• severe hepatic impairment;
• severe blood coagulation disorders;
• severe renal insufficiency without possibility of hemofiltration or dialysis;
• shock;
• the unstable condition of the patient (e. g., traumatic shock, decompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotension, dehydration).
• pulmonary edema;
• hyperhydration;
• decompensated heart failure.

With caution:  impaired fat metabolism, which can be observed in patients with renal insufficiency, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis. Clinical experience with SMOFlipid in patients with diabetes mellitus and renal insufficiency is limited.

Side effects

Respiratory, thoracic and mediastinal disorders:  rarely-shortness of breath.

From the gastrointestinal tract:  infrequently-loss of appetite, nausea, vomiting.

From the side of blood vessels:  rarely — decrease HELL, raising HELL.

General disorders and disorders at the injection site:  often-a slight increase in body temperature; infrequently-chills; rarely-hypersensitivity reactions (anaphylactic and anaphylactoid reactions, skin rash, urticaria, hyperemia, headache), a feeling of warmth or cold, pallor, cyanosis, pain in the neck, chest and lower back.

From the genitals and mammary glands:  very rarely — priapism.

Interaction

The use of heparin in clinical doses causes a transient increase in the secretion of lipoprotein lipase into the bloodstream. Initially, this may lead to an increase in plasma lipolysis, and then to a temporary decrease in triglyceride clearance.

Soy oil is a source of natural vitamin K_-1. However, the content of this vitamin in SMOFlipid does not significantly affect the blood clotting process in patients treated with indirect anticoagulants — coumarin derivatives.

The addition of other medications or medicinal substances to the SMOFlipid emulsion is usually not recommended, unless their compatibility is proven.

SMOFlipid can be mixed with fat-soluble (Vitalipid) and water-soluble (Soluvit) vitamins.

SMOFlipid under aseptic conditions can be mixed with solutions of amino acids, glucose and electrolytes to produce an all-in-one parenteral nutrition solution.

When prescribing SMOFlipid with other infusion media (for example, solutions of amino acids, glucose) through a conventional system for intravenous infusions, the compatibility of the solutions and emulsions used must be guaranteed.

How to take, course of use and dosage

For central or peripheral vein infusion. The dose and rate of infusion should be determined by the patient’s ability to eliminate intravenous lipids. The standard dose is 1-2 g of fat/kg of body weight / day, which corresponds to 5-10 ml of the drug/kg/day.

Maximum daily dose: 2 g of fat/kg / day, which corresponds to 10 ml of the drug/kg / day.

The recommended infusion rate is 0.125 g of fat / kg of body weight / h, which corresponds to 0.63 ml of SMOFlipid /kg of body weight/h. The infusion rate should not exceed 0.15 g of fat / kg of body weight / h, which corresponds to 0.75 ml of SMOFlipid /kg of body weight/h.

Overdose

Reduced ability to eliminate triglycerides can lead to the development of fat overload syndrome, which can be caused by an overdose of any fat emulsions.

It is necessary to pay attention to possible signs of metabolic overload. The causes of impaired lipid metabolism may be genetic (individual differences in metabolism), in addition, current or previous diseases may affect fat metabolism.

This syndrome can also develop during severe hypertriglyceridemia, even at the recommended infusion rate, and may be accompanied by a sudden change in the patient’s clinical condition, such as the appearance of renal failure or infection.

Fat overload syndrome is characterized by hyperlipemia, fever, fat infiltration, hepatomegaly with or without jaundice, splenomegaly, leukopenia, thrombocytopenia, blood clotting disorders, hemolysis, reticulocytosis, abnormal results of functional liver tests and the development of coma.

Discontinuation of the fat emulsion infusion results in the disappearance of all symptoms.

Form of production

Emulsion for infusions

Storage conditions

At a temperature not exceeding 25 °C (do not freeze)

Shelf life

2 years

Active ingredient

Amino acids for parenteral nutrition

Conditions of release from pharmacies

By prescription

Dosage form

emulsion for infusions