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Pharmacological properties

fat emulsion particles have a size and biological properties similar to endogenous chylomicrons. smoflipid 20% is an energy source. Soybean oil is high in essential fatty acids. omega-6 fatty acids and linoleic acid account for the largest share (55-60%). alpha-linoleic acid and omega-3 fatty acids account for almost 8%. this part of smoflipid 20% provides the necessary amount of essential fatty acids, which are quickly oxidized and provide the body with energy. olive oil provides mainly energy in the form of monounsaturated fatty acids, which are less prone to peroxidation than the corresponding amount of polyunsaturated fatty acids. fish oil is characterized by a high content of eicosapentaenoic acid (epa) and docosahexaenoic acid (dha). dha is an important structural component of cell membranes, while epa is a precursor to eicosanoids (prostaglandins, thromboxanes and leukotrienes).

Vitamin E protects unsaturated fatty acids from lipid peroxidation.

Pharmacokinetics Separately, TGs have different excretion rates, but SMOFlipid 20% as a mixture is excreted faster than long-chain TG (LCT) during infusion. Olive oil has the slowest excretion rate, unlike other components (slightly slower than LCT), and medium chain TG (MCT) has a high speed. Fish oil mixed with LCT has the same elimination rate as when used separately.

Indications

Smoflipid is a source of energy, essential fatty acids and omega-3 fatty acids for patients with parenteral nutrition, when oral or enteral nutrition is impossible, insufficient or contraindicated.

Application

IV infusion into the central or peripheral veins.

Adults The standard dose is 1–2 g of fat / kg body weight / day, which corresponds to 5–10 ml of the drug / kg / day.

The recommended infusion rate is 0.125 g fat / kg body weight / h, which corresponds to 0.63 ml of SMOFlipid 20% / kg / h. The infusion rate should not exceed 0.15 g fat / kg / h, which corresponds to 0.75 ml of SMOFlipid 20% / kg / h.

Newborns. The initial dose should be 0.5-1.0 g fat / kg / day, followed by a dose increase of 0.5-1.0 g fat / kg / day.

It is not recommended to exceed the daily dose of 3 g of fat / kg / day, which corresponds to 15 ml of SMOFlipida 20% / kg / day.

The infusion rate should not exceed 0.125 g fat / kg / h.

In premature and newborns with insufficient body weight, SMOFlipid should be administered continuously for 24 hours.

Children. It is not recommended to exceed a dose of 3 g fat / kg / day, which corresponds to 15 ml of SMOFlipid 20% / kg / day.

The daily dose should be increased gradually during the 1st week of administration.

The infusion rate should not exceed 0.15 g fat / kg / h.

Contraindications

Hypersensitivity to fish, egg, soy protein or any of the active or excipients; severe hyperlipidemia; severe liver failure; severe coagulation disorders; severe renal failure without hemofiltration or dialysis; acute shock; general contraindications to infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure; unstable state (for example, after severe injuries, decompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration).

Side effects

After using the drug, adverse reactions were noted with such a frequency: very often (1/10;) often (1/100, 1/10); infrequently (1/1000, 1/100); rarely (1/10 000, 1/1000); very rarely (1/10 000).

On the part of the respiratory system: rarely - shortness of breath.

From the digestive system: infrequently - lack of appetite, nausea, vomiting.

From the vascular system: rarely - arterial hypotension, hypertension.

General adverse reactions and reactions at the injection site: often - a slight increase in body temperature; infrequently - a feeling of cold; rarely - hypersensitivity reactions (anaphylactic reactions, rash, urticaria, redness, headache), sensation of heat or cold, pallor, cyanosis, pain in the neck, back, bones, chest and lower back.

From the reproductive system: very rarely - priapism.

In case of adverse reactions, the infusion of SMOFlipid 20% should be discontinued or continued at a reduced dose.

If the level of TG during the infusion rises above 3 mmol / L, the introduction of SMOFlipid 20% should be discontinued or, if necessary, continue, reducing the dose. During treatment, along with amino acids and glucose, SMOFlipid 20% should always be part of a comprehensive parenteral nutrition. Nausea, vomiting, and hyperglycemia are symptoms that are associated with parenteral nutrition conditions.

It is recommended to monitor the level of TG and blood glucose in order to avoid elevated levels, which can be dangerous.

Fat overload syndrome: impaired potential for TG elimination can lead to fat overload syndrome. It is necessary to monitor this manifestation, which may occur as a result of an overdose. Also, the cause of the syndrome may be a genetically determined individual characteristic of the metabolism, diseases with impaired fat metabolism or past illnesses. The syndrome can also appear during severe hypertriglyceridemia, even at the recommended infusion rate, and in connection with a sharp change in the patients clinical condition: renal failure or infection.

Fat overload syndrome is characterized by hyperlipidemia, fever, fatty infiltration, hepatomegaly, including jaundice, splenomegaly, anemia, leukopenia, thrombocytopenia, impaired coagulation, hemolysis and reticulocytosis, impaired liver and coma.

If signs of fat overload syndrome occur, the infusion should be discontinued.

special instructions

The potential for eliminating fat is individual, and therefore, medical monitoring of the tg level is required. especially caution should be used in patients with a pronounced risk of hyperlipidemia (for example, patients with a high dose of lipids, severe sepsis, newborns with low birth weight). the concentration of tg in blood plasma, as a rule, does not exceed 3 mmol / l during infusion. a dose reduction or cessation of the administration of a fat emulsion should be considered if the concentration of tg in the blood serum or blood plasma during or after the infusion exceeds 3 mmol / L. an overdose can cause fat overload syndrome. This medicine contains soybean oil, fish oil, and egg yolk phospholipids, which can occasionally cause allergic reactions. a cross-allergic reaction occurs between soybeans and peanuts.

SMOFlipid 20% should be used with caution in conditions of impaired lipid metabolism, which can occur in patients with liver failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism and sepsis. Clinical data regarding patients with diabetes mellitus or with liver failure are limited.

The use of medium chain fatty acids can lead to metabolic acidosis. This risk is largely eliminated by the simultaneous introduction of long chain fatty acids included in SMOFlipid 20%. The simultaneous use of carbohydrates helps to eliminate this threat.

Thus, simultaneous administration of carbohydrates containing amino acids is recommended. Laboratory studies, mainly related to I / O monitoring, should be performed regularly.These include blood glucose control, liver function, basic acid metabolism, fluid balance, a general blood count and electrolytes. For any manifestation of an anaphylactic reaction (for example, high body temperature, chills, rash, shortness of breath), the infusion should be stopped immediately. SMOFlipid 20% should be used with caution in newborns and premature babies, newborns with hyperbilirubinemia and in cases of pulmonary hypertension. In newborns, especially premature babies, who have been prescribed parenteral nutrition for a long period, they should check their blood counts for platelets, liver tests, and blood plasma TG samples.

High plasma lipids can affect some laboratory blood tests, such as hemoglobin levels.

The use of other medicinal substances along with 20% SMOFlipid should generally be avoided, unless compatibility is known.

Use during pregnancy and lactation. There is no data on the effect of SMOFlipid 20% during pregnancy and lactation. No reproductive toxicity studies have been performed. SMOFlipid 20% should be used in pregnant and lactating women after a thorough examination. The drug should be prescribed only when the expected beneficial effect for the mother outweighs the potential risk to the fetus.

Children. Apply in pediatric practice (see. APPLICATION).

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.

Interactions

The use of heparin in therapeutic doses causes a transient increase in the amount of lipoproteins in the blood. at first, this can lead to a temporary increase in plasma lipolysis, and then to a decrease in the level of tg.

SMOFlipid 20%, adhering to aseptic conditions, can be mixed with amino acid, glucose and electrolyte solutions, preparing a solution for complete parenteral nutrition "All in one".

Incompatibility. The drug should not be mixed with other drugs, with the exception of the above.

Overdose

An overdose can cause fat overload syndrome if the infusion is too fast or the infusion is too long at the recommended rate due to changes in the clinical condition of patients, for example, the occurrence of liver failure or infection. overdose can lead to side effects. in these cases, lipid infusion should be discontinued or, if necessary, continued, reducing the dose.

Storage conditions

At a temperature not exceeding 25 ° C. do not freeze! the shelf life after the first opening of the bottle is no more than 24 hours at a temperature of 2-8 ° C.

Tags: Smoflipid