SMOFLIPED (SMOFlipid)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspemulsion for infusions
Composition:
1000 ml of emulsion contains:

Active substances:

Soybean oil (refined)

60.0 grams

Medium chain triglycerides

60.0 grams

Olive oil (refined)

50.0 grams

Fish oil purified

30.0 grams

Excipients:

Phospholipids of egg yolk

12.0 g

Glycerol (anhydrous)

25.0 g

d1-α-tocopherol

160-230 mg

Sodium oleate

0.30 g

Sodium hydroxide (for pH correction)

q.s. up to pH 8

Water for injections

up to 1000 ml

Energy value

8.4 MJ / L (= 2000 kcal / L)

pH

7,5-9,0

Theoretical osmolality

380 mOsm / kg H2ABOUT
Description:

Homogeneous emulsion of white color

Pharmacotherapeutic group:nutrition parenteral remedy
ATX: & nbsp
  • Fatty emulsions
    • Pharmacodynamics:

    SMOFLipid in particle size and biological properties is identical to endogenous chylomicrons.

    Components of the drug - soybean oil, medium chain triglycerides, olive oil and fish oil - except for differences in composition and energy value, have their own pharmacodynamic properties.

    AT soybean oil contains a large number of essential fatty acids. It is most rich in linoleic acid (approximately 55-60%). which is ω-6 fatty acid. 8% of the composition of soybean oil is presented α-linolenic acid, which is ω-3 fatty acid. This part of the drug provides the necessary amount of essential fatty acids.

    Through medium chain fatty acids the body is provided with quick-access energy, thanks to their ability to rapidly oxidize.

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

    Fish fat 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 of eicosanoids, such as prostaglandins, thromboxanes and leukotrienes.

    Vitamin E protects unsaturated fatty acids from peroxidation.
    Pharmacokinetics:

    Various triglycerides in the composition of the drug SMOFLipid have different clearance rates, but SMOFLipid on average (as a mixture) is eliminated faster than long-chain triglycerides (LCT). The lowest clearance from all components in olive oil (slightly lower than LCT), and the highest ground clearance - the medium chain triglycerides (MCT). Fish oil in the mixture LCT Has the same clearance as clean LCT.

    Indications:

    - Complete or partial parenteral nutrition as a source of energy and essential fatty acids, including ω-3 fatty acids, when oral or enteral nutrition is impossible, insufficient or contraindicated;

    - prevention and treatment of insufficiency (deficiency) of essential fatty acids, including number of ω-3 fatty acids.

    Contraindications:

    - Hypersensitivity to proteins of fish, eggs, soy, peanuts or to the components of the drug;

    - severe hyperlipidemia;

    severe hepatic impairment;

    - severe blood clotting disorders;

    - severe renal failure without the possibility of haemofiltration or dialysis;

    - shock;

    - general contraindications to infusion therapy: pulmonary edema, hyperhydration and decompensated heart failure;

    - unstable condition of the patient (for example, traumatic shock, decompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration).

    Carefully:

    SMOflipid should be used with caution in patients with impaired fat metabolism, which can be observed in patients with renal insufficiency, diabetes, pancreatitis, impaired liver function, hypothyroidism and sepsis. The clinical experience of using the drug SMOFLipid in patients with diabetes mellitus and renal insufficiency is limited.

    Newborn and premature newborns with hyperbilirubinemia or pulmonary hypertension SMOFLipid should be administered with caution. In newborns and premature infants, for a long time on parenteral nutrition, it is necessary to monitor the number of platelets, the liver function and the concentration of triglycerides in the serum.

    Pregnancy and lactation:

    No special controlled clinical trials for pregnancy and breast-feeding have been conducted, so the use of this drug in this category of patients is acceptable if the expected benefit to the mother exceeds the potential risk to the fetus or the baby.

    Dosing and Administration:

    For infusion into the central or peripheral vein.

    The dose and rate of infusion should be determined by the patient's ability to eliminate intravenous lipids (see section "Precautions for Use"). There is an experience of using the drug for more than 14 days, the duration of the course of treatment depends on the clinical condition and individual characteristics of the patient.

    Adults

    The standard dose of lipids is 1.0-2.0 g / kg of body weight / day, which corresponds to 5-10 ml of the drug / kg of body weight per day. The maximum daily dose of 2 grams of fat / kg of body weight per day, which corresponds to 10 ml of the drug / kg of body weight per day.

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

    Newborns and children under 1 year old

    The initial dose of lipids in children should be 0.5-1.0 g fat / kg body weight per day. Subsequently, the dose can be gradually increased by 0.5-1.0 g fat / kg body weight per day to a maximum of 3.0 g fat / kg body weight per day.

    It is not recommended to exceed the maximum dose of lipids, equal to 3 g fat / kg body weight per day, which corresponds to 15 ml / kg of body weight per day.

    The infusion rate should not exceed 0.125 g fat / kg body weight per hour.

    Premature newborns and newborns with a low body weight SMOFLipid should be administered as a continuous infusion within 24 hours.

    Children

    It is not recommended to exceed the maximum dose of lipids, equal to 3 g fat / kg body weight per day, which corresponds to 15 ml / kg of body weight per day.

    The daily dose of the drug SMOFLipid should be increased gradually during the first week of therapy.

    The infusion rate should not exceed 0.125 g fat / kg body weight per hour.

    Side effects:

    Frequent (≥l / 100. up to <1/10)

    Infrequent (≥1/1000, to <1/100)

    Rare (≥1/10000, up to <1/1000)

    Very rare (<1/10000)

    Disorders from the respiratory, thoracic and mediastinal

    Dyspnea

    Disorders from the gastrointestinal tract

    Violation appetite, nausea, vomiting

    Vascular disorders

    Decrease arterial pressure, rise arterial pressures

    General disorders and disorders at the site of administration

    Lung rise temperatures bodies

    Chills

    Hypersensitivity reactions (anaphylactic and anaphylactoid reactions, skin rash, urticaria, hyperemia, headache), sensation of heat or cold, pallor, cyanosis, pain in the neck, chest and lower back

    Violations of the genitals and mammary gland


    Priapism

    If you experience any of these side effects or if the triglyceride concentration is higher than 3 mmol / L, any fat emulsion should be discontinued or, if necessary, continued at a lower rate.

    SMOFLipid should always be administered as part of parenteral nutrition simultaneously with amino acids and glucose. Nausea, vomiting and hyperglycemia may be symptoms of a disease for which parenteral nutrition is prescribed; in addition, they can be directly related to parenteral nutrition.

    To prevent elevated levels of triglycerides and glucose (which can be dangerous for the patient), monitoring of their concentration in the blood is recommended.

    Overdose:

    Reduced ability to eliminate triglycerides can lead to "fat overload syndrome"which can be caused by an overdose of any fat emulsions.The possible signs of metabolic overload should be monitored.The reason may be genetic (individual difference in metabolism), or the continued or previous illnesses can affect fat metabolism.This syndrome can also develop during severe hypertriglyceridemia even at the recommended rate of infusion and accompanied by a sudden change in the clinical condition of the patient, for example, the advent of renal failure or addition infection. fat overload syndrome is characterized by hyperlipemia, fever, fat infiltration, hepatomegaly with or without jaundice, splenomegaly, leukopenia, thrombocytopenia, blood coagulation disorders, hemolysis, reticulocytosis, pathological results of liver function tests and development of coma.

    Termination of infusion of fat emulsion leads to the disappearance of all symptoms.

    Interaction:

    Heparin in clinical doses causes a transient increase in lipoprotein lipase secretion into the bloodstream. Initially, this can lead to increased plasma lipolysis followed by a temporary decrease in triglyceride clearance.

    Soybean oil is a source of natural vitamin K1. However, the content of this vitamin in the formulation SMOFlipid has no significant effect on the process of blood clotting in patients treated with indirect anticoagulants - coumarin derivatives.

    Addition of other drugs or medicinal substances in the emulsion of SMOFLipid is usually not recommended, except when their compatibility is proven.

    SMOFLipid can be mixed with preparations of fat-soluble vitamins (Vitalipid) and water-soluble vitamins (Solovit).

    SMOFLipid in aseptic conditions can be mixed with solutions of amino acids, glucose and electrolytes to obtain a solution for parenteral nutrition "All in One".

    When SMOfLipid is administered with other infusion media (eg, amino acid solutions, glucose solutions) through a conventional intravenous system, the compatibility of the solutions and emulsions used must be guaranteed.

    Special instructions:

    Precautions for use

    The ability to metabolize fat is individual for each patient, so the lipid profile of patients should be constantly monitored. Usually monitoring is reduced to a daily determination of the level of triglycerides. Particular attention should be paid to patients at risk of developing hyperlipidemia (for example, patients who are prescribed high doses of fat emulsion, patients with severe sepsis,newborns with extremely low birth weight). The concentration of triglycerides in plasma during infusion usually should not exceed 3 mmol / l. If the plasma or serum triglyceride concentration increases during or after the infusion of the drug SMOFLIPID above 3 mmol / l, the possibility of reducing the dose or eliminating the fat emulsion should be considered. Overdose of lipids can lead to a syndrome of overload with fat.

    SMOflipid contains soybean oil, fish oil and egg phospholipids, which in rare cases can cause allergic reactions. Allergy to soy and peanuts can be cross-linked.

    The appointment of some medium chain fatty acids can lead to the development of metabolic acidosis. The risk of its development is significantly reduced with the simultaneous administration of long-chain fatty acids that are part of the preparation SMOFLipid. Simultaneous with the fat emulsion, the introduction of carbohydrates further reduces the risk of developing metabolic acidosis. Thus, simultaneously with the infusion of fat emulsion, it is recommended to infuse a solution of carbohydrates or an amino acid solution containing carbohydrates.

    It is necessary to conduct laboratory monitoring for patients receiving parenteral nutrition, which includes the determination of blood glucose concentration, liver function parameters, acid-base state, electrolyte plasma composition, hydrobalance and general blood analysis.

    If any signs of an anaphylactic reaction (such as fever, chills, rash or dyspnea) occur, the drug infusion should be discontinued.

    High plasma lipid concentrations can lead to incorrect results in some laboratory tests, for example, the hemoglobin content.

    Special Precautions

    Use only a homogeneous emulsion.

    Before using the drug, it is necessary to visually assess it for the presence of phase separation, and also to ensure that there is no phase separation after the preparation of the infusion solution (after mixing with other preparations for parenteral nutrition).

    Only for single use.

    The unused emulsion or the remainder of the mixture must be destroyed.

    Effect on the ability to drive transp. cf. and fur:

    It was not reported on the effect of the drug on the ability to drive and work with machinery.

    Form release / dosage:

    Emulsion for infusion, 20%.

    Packaging:

    To 100 ml, 250 ml or 500 ml in a bottle of colorless glass, corked with a rubber stopper, coated with an aluminum cap with a plastic cap-control the first opening.

    10 bottles each, with or without holders, together with instructions for use, are placed in a cardboard box.

    Storage conditions:

    Store at a temperature not exceeding 25 FROM.

    Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002666
    Date of registration:30.12.2011
    The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany
    Information update date: & nbsp13.03.2016
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