SMOFlipid - Instructions For Use, Emulsion Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

SMOFlipid

SMOFlipid: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: SMOFlipid

ATX code: B05BA02

Active ingredient: fat emulsions for parenteral nutrition

Producer: Fresenius Kabi Austria, GmbH (Austria)

Description and photo update: 2019-25-12

Prices in pharmacies: from 3496 rubles.

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SMOFlipid - means for parenteral nutrition; fat emulsion.

Release form and composition

The preparation is produced in the form of an emulsion for infusion: a homogeneous suspension of white color (100, 250 or 500 ml each in a colorless glass vial, sealed with a rubber stopper, rolled in an aluminum cap, equipped with a plastic cap to control the first opening; in a cardboard box 10 vials with or without holders them and instructions for the use of SMOFlipid).

1000 ml of emulsion contains:

• active ingredients: medium-chain triglycerides (MCT) - 60 g; soybean oil (refined) - 60 g; olive oil (refined) - 50 g; refined fish oil - 30 g;
• additional components: glycerol (anhydrous) - 25 g; egg yolk phospholipids - 12 g; d, l-α-tocopherol - 0.16-0.23 g; sodium hydroxide - qs to pH 8 (for pH correction); sodium oleate - 0.3 g; water for injection - up to 1000 ml.

Indicators: pH - 7.5-9; energy value - 8.4 MJ / l (2000 kcal / l); theoretical osmolarity - 380 mOsm / kg H ₂ O.

Pharmacological properties

Pharmacodynamics

The particle size of the drug and its biological properties are identical to endogenous chylomicrons. The active components of SMOFlipid, in addition to differences in energy value and composition, have their own individual pharmacodynamic properties:

• medium-chain fatty acids: supply the body with readily available energy, since they are distinguished by their ability to accelerate the oxidation reaction;
• soybean oil: contains a large number of essential fatty acids (EFAs), among which linoleic acid, which is an ω (omega) -6 fatty acid, accounts for about 55-60%, and α-linolenic, which belongs to the ω-3 fatty acid family acid - about 8% of the composition of soybean oil; this active substance provides the body with the necessary amount of EFAs;
• olive oil: delivers energy in the form of monounsaturated fatty acids, which undergo oxidation to a much lesser extent compared to the same amount of polyunsaturated fatty acids;
• fish oil: contains large amounts of eicosapentaenoic (EPA) and docosahexaenoic (DHA) acids; DHA is an important structural component of cell membranes, EPA refers to the precursors of eicosanoids, including prostaglandins, leukotrienes, thromboxanes;
• vitamin E (d, l-α-tocopherol): protects unsaturated fatty acids from peroxidation reactions.

Pharmacokinetics

Various triglycerides included in SMOFlipid are characterized by different clearance rates, but the drug itself, on average (as a mixture), is eliminated at a higher rate than long-chain triglycerides (LCT). Of all the ingredients, olive oil has the lowest clearance (slightly lower than LCT), and the highest is MCT. The fish oil in the LCT blend has the same clearance as the pure LCT.

Indications for use

• partial or total parenteral nutrition as a source of energy and EFAs, including ω-3 fatty acids, in cases where oral / enteral nutrition is not possible, insufficient or contraindicated;
• treatment and prevention of deficiency (deficiency) of EFAs, including ω-3 fatty acids.

Contraindications

Absolute:

• severe blood clotting disorders;
• severe hyperlipidemia;
• severe renal failure in the absence of the possibility of hemofiltration or dialysis;
• severe liver failure;
• shock;
• hyperhydration, decompensated heart failure, pulmonary edema and other general contraindications to infusion therapy;
• an unstable condition such as hypotonic dehydration, decompensated diabetes mellitus, traumatic shock, metabolic acidosis, stroke, embolism, acute myocardial infarction, severe sepsis;
• hypersensitivity to proteins of eggs, peanuts, soybeans, fish or to other components of the SMOFlipid emulsion.

Relative (the product should be used with extreme caution due to a possible violation of fat metabolism):

• renal failure;
• impaired liver function;
• pancreatitis;
• diabetes mellitus (clinical experience of use is insufficient);
• hypothyroidism;
• sepsis.

SMOFlipid, instructions for use: method and dosage

The SMOFlipid emulsion is administered as an intravenous (IV) infusion into a central or peripheral vein.

The dose and rate of infusion will be adjusted based on the patient's ability to eliminate IV lipids. There is experience of using a fat emulsion for more than 14 days, the course of treatment is determined based on the individual characteristics and clinical condition of the patient.

The recommended dosage regimen of SMOFlipid, depending on the age of the patients:

• adults: the standard dose is 5-10 ml / kg / day, which is proportional to lipids at a dose of 1-2 g / kg / day, the maximum daily dose of the drug should not exceed 10 ml / kg / day, which is proportional to lipids at a dose of 2 g / kg / day; the infusion rate can be 0.63–0.75 ml / kg / h, which corresponds to lipids at a dose of 0.125–0.15 g / kg / h; maximum infusion rate - 0.75 ml / kg / h;
• children: in newborns and children under 1 year of age, the initial dose of lipids should be 0.5–1 g / kg / day of fat; further, a gradual increase in the dose by 0.5–1 g / kg / day to a maximum of 3 g / day is allowed. kg / day of fat; the drug should not be administered at a dose exceeding 15 ml / kg / day, which is proportional to lipids at a maximum dose of 3 g / kg / day of fat; the daily dose of SMOFlipid should be increased gradually during the first week of treatment, the maximum infusion rate is 0.125 g / kg / h of fat; Low birth weight and premature infants require SMOFlipid as a continuous infusion over 24 hours.

Side effects

With infusion parenteral nutrition with the use of SMOFlipid from the side of systems and organs, the following adverse reactions may develop:

• respiratory system, organs of the chest and mediastinum: rarely - shortness of breath;
• cardiovascular system: rarely - decrease / increase in blood pressure (BP);
• digestive tract: infrequently - nausea, impaired appetite, vomiting;
• general disorders and disorders at the injection site: often - a slight increase in body temperature; infrequently - chills; rarely - pallor, feeling of warmth / coldness, pain in the chest, back, neck, lower back; cyanosis, hypersensitivity reactions (hyperemia, urticaria, skin rash, headache, anaphylactoid and anaphylactic reactions);
• genitals and mammary gland: extremely rare - priapism.

In the event of these adverse events or an increase in the plasma triglyceride content of more than 3 mmol / l, the infusion of the emulsion must be discontinued, or, if necessary, continue the infusion by reducing the rate.

SMOFlipid should always be administered as part of a parenteral nutritional supplement that includes amino acids and glucose.

Hyperglycemia, nausea, and vomiting may be symptoms of a condition that is being given parenteral nutrition, and may also be caused by parenteral nutrition.

Since this can be dangerous for patients, in order to prevent an increase in the concentration of triglycerides and glucose, it is recommended to monitor their blood levels.

Overdose

With a reduced ability to remove triglycerides from the body, the risk of fat overload syndrome increases, as a result of an overdose of any fat emulsions. In this connection, it is required to timely identify possible symptoms of metabolic overload. The processes of fat metabolism can be influenced by previous or current diseases, or an individual difference in the metabolism of genetic etiology. This complication can appear against the background of severe hypertriglyceridemia, even with the recommended frequency of infusion, and be accompanied by a sharp change in condition, for example, the addition of an infection or the development of renal failure. Manifestations of fat overload syndrome can be: fever, hyperlipemia, fatty infiltration, splenomegaly, hepatomegaly with or without jaundice, thrombocytopenia, leukopenia, hemolysis,coagulation disorders, reticulocytosis, abnormal liver test results and coma.

Termination of the infusion of SMOFlipid leads to the removal of all symptoms.

special instructions

Each patient's ability to metabolize lipids is individual, therefore, the indicators of fat metabolism must be constantly monitored, daily determining the level of triglycerides. Patients with a threat of hyperlipidemia, for example, when prescribing high doses of fat emulsion, the presence of severe sepsis, and newborns with very low birth weight, require special attention. If the plasma / serum triglyceride content during or after the SMOFlipid infusion is more than 3 mmol / L, the possibility of reducing the dose or discontinuing treatment should be considered.

The emulsion contains egg phospholipids, soybean oil and fish oil, which in some cases can provoke allergic reactions. Allergies to peanuts and soy can be cross-linked.

With the introduction of medium-chain fatty acids alone, the risk of developing metabolic acidosis is aggravated. The threat of this complication is significantly reduced with the simultaneous use of long-chain fatty acids contained in SMOFlipid, as well as with a combined administration with a carbohydrate preparation. Thus, simultaneously with the infusion of the fat emulsion, the infusion of a carbohydrate solution or carbohydrate-containing amino acid solutions should be carried out.

It is required to regularly conduct laboratory tests related to monitoring parenteral nutrition, including a complete blood count, determination of blood glucose levels, liver activity indicators, electrolyte composition, acid-base state and hydrobalance.

If any symptom of an anaphylactic reaction appears (shortness of breath, fever, chills, rash), the infusion of SMOFlipid should be stopped immediately.

High plasma lipids can affect the results of some laboratory tests, in particular hemoglobin levels.

It is allowed to use only a homogeneous emulsion.

Before the infusion of SMOFlipid, including after mixing the emulsion with other means for parenteral nutrition, it is necessary to make sure that there is no phase separation in the solution.

The vial with the SMO Flipid emulsion is intended for single use. Unused emulsion or the rest of the mixture must be disposed of.

Influence on the ability to drive vehicles and complex mechanisms

There are no reports of the effect of parenteral nutrition on the ability to concentrate and the speed of psychomotor reactions.

Application during pregnancy and lactation

Special adequately controlled studies on the use of the drug during pregnancy and during lactation have not been conducted. As a result, the use of SMOFlipid in this category of patients is possible only if the expected benefit for the woman significantly exceeds the possible threat to the fetus or child.

Pediatric use

It is necessary to use SMOFlipid with extreme caution in newborns, including premature infants with pulmonary hypertension or hyperbilirubinemia. Such children, who are on parenteral nutrition for a long period, need regular counting of platelets, monitoring of liver function indicators and serum triglycerides.

With impaired renal function

For patients with severe renal failure who are unable to undergo hemodialysis or hemofiltration, the use of SMOFlipid is contraindicated.

In the setting of moderate renal failure, fat emulsion should be used with caution, since clinical experience with its use is limited.

For violations of liver function

In the presence of severe liver failure, the use of the drug is contraindicated.

In patients with moderate hepatic impairment, SMOFlipid should be used with caution.

Drug interactions

Possible interaction of SMOFlipid with other drugs when used together:

• heparin (in clinical doses): there is a transient increase in the production of lipoprotein lipase into the bloodstream, which can first cause an increase in plasma lipolysis, and then a temporary decrease in triglyceride clearance;
• indirect anticoagulants - coumarin derivatives: no effect on the coagulation process is noted, since natural vitamin K _{1 is} contained in soybean oil in extremely low quantities and does not significantly affect blood coagulation;
• water-soluble vitamins (Soluvit), fat-soluble vitamins (Vitalipid): mixing with an emulsion is allowed;
• solutions of glucose, amino acids and electrolytes: it is possible to mix SMOFlipid with these means to obtain a solution for parenteral nutrition "All in one".

When prescribing SMOFlipid with amino acid solutions, glucose solutions and other infusion media through a conventional system for intravenous infusion, full compatibility of the solutions and emulsions used must be guaranteed.

Analogs

Analogs of SMOFlipid are Lipofundin MCT / LST 10%, Lipoplus 20, Lipofundin MCT / LST 20%, Intralipid, Omegaven, etc.

Terms and conditions of storage

Keep out of reach of children, at a temperature not exceeding 25 ° C, without freezing.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Released for hospitals.

Reviews about SMOFlipid

Within the framework of the Euro-Asian Neonatal Forum, held in Yekaterinburg in 2018, SMOFlipid was included in the list of complete parenteral nutrition in neonatology. According to some experts, a mixture of lipids, oils and fish oil in early pregnancy provides nutrition and placenta in women with problems of gestation, which reduces the likelihood of fetal rejection.

There are not enough other reviews about SMOFlipid that would allow to reliably assess its effectiveness and safety at the moment.

Price for SMOFlipid in pharmacies

The price of SMOFlipid, an emulsion for infusion 20%, for 10 bottles in a package can be: 100 ml bottles - 3450 rubles; bottles of 500 ml - 6000 rubles.

SMOFlipid: prices in online pharmacies

Drug name Price Pharmacy

Smoflipid 20% emulsion for infusion 100 ml 10 pcs. 3496 RUB Buy

Smoflipid 20% emulsion for infusion 500 ml 10 pcs. 6101 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!