Lipofundin MST / LST 10% (Lipofundin MCT / LCT 10%)

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 beans

50.00 grams

Medium chain triglycerides

50.00 grams

Auxiliary substances:


Lecithin Egg

8.00 g

Glycerol

25.00 grams

Sodium oleate

0.30 g

α-Tocopherol

0.100 g

Water for Injection

up to 1000 ml

The content of essential fatty acids:

Linoleic acid

24.0 -29.0 g / l

α-Linolenic acid

2.5-5.5 g / l

Energy value:

4280 kJ / l (1022 kcal / l)

Physico-chemical characteristics:

Theoretical osmolality

345 mOsm / l

Titration acidity or alkalinity (up to pH = 7.4)

<0.5 mmol / l

pH

6,5-8,8

Description:

An emulsion of oil-in-water type, milky white, without visible foreign matter.

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

    Lipofundin MST / LST 10% as part of the parenteral nutrition regimen is a source of energy and polyunsupsense ("essential") fatty acids. To this end, Lipofundine MST / LST 10% contains medium chain triglycerides, long chain triglycerides (soybean oil), phospholipids (egg lecithin) and glycerol.

    Triglycerides of the middle chain are faster than hydrolyzed, digested and completely oxidized when compared to long chain triglycerides.They are a more preferred source of energy, especially when the metabolic processes and / or triglycerides of the long chain are disturbed, for example, in the case of lipoprotein lipase deficiency, lipoprotein lipase cofactors, carnitine and a carnitine-dependent transport system.

    Unsaturated fatty acids, which are part of long chain triglycerides, are used in the body mainly for the prevention and treatment of a deficiency of essential fatty acids and only in the second place as an energy source.

    Phospholipids, in addition to their function as emulsifier triglycerides, are components of cell membranes and are necessary for their fluidity and performance of biological functions.

    Glycerol, added to give the emulsion is isotonicity, is an intermediate substance of the metabolism of glucose and lipids: it is metabolized in the process of glycolysis with educationenergy or used forI synthesis of glucose, glycogen and triglycerideaboutat.

    During the pharmacological safety study, only the nutritional therapeutic effect of the drug was found, similar to the therapeutic effect of oral administration of the drug components.

    Pharmacokinetics:

    Suction

    Bioavailability. Because Lipofundin MST / LST 10% is administered intravenously, the bioavailability of all its components is 100%. The maximum individual concentration of triglycerides in the blood plasma depends on the dose, rate of administration, metabolic status and the patient's state (degree of depletion). When administered according to the instructions for use with a dose, the concentration of triglycerides in the blood plasma does not usually exceed 4 mmol / l.

    Distribution

    The affinity of medium-chain fatty acids to albumin is somewhat less than that of long-chain fatty acids, nevertheless, when the recommendations for dosing of the drug are observed, medium chain and long chain fatty acids almost completely bind to albumin of the plasma.

    When the dose is observed, the medium-chain and long-chain fatty acids do not penetrate the blood-brain barrier and, therefore, do not enter the cerebrospinal fluid.

    Data on penetration through the placental barrier and into breast milk are absent.

    Metabolism

    After administration, triglycerides are hydrolyzed to glycerol and fatty acids. Both components are metabolized with the formation of energy or used for the synthesis of biologically active substances, gluconeogenesis and lipid resynthesis.

    Excretion

    The half-life of the components of the drug Lipofundin MST / LST 10% from the plasma is approximately 9 minutes. There are no kidney triglycerides or free fatty acids. Forced diuresis or hemodialysis does not lead to withdrawal of components of Lipofundin MST / LST 10%. When an overdose of Lipofundin MST / LST 10% does not occur intoxication, requiring forced diuresis or hemodialysis.

    Indications:

    - An energy source that includes an easily utilizable lipid component (medium chain triglycerides);

    - providing the body with essential fatty acids in the composition of parenteral nutrition.

    Contraindications:

    The drug can not be administered under the following conditions:

    - hypersensitivity to egg white or soybean protein, peanut oil or any of the active or auxiliary substances;

    - severe hyperlipidemia;

    - severe blood clotting disorders;

    - severe hepatic impairment;

    - intrahepatic cholestasis;

    - acute phase of myocardial infarction or stroke;

    - acute thromboembolism;

    - fat embolism.

    General contraindications for parenteral nutrition:

    - an unstable, life-threatening circulatory disorder (collapse and shock);

    - unstable metabolism (eg, severe post-traumatic syndrome, decompensated diabetes mellitus, severe sepsis, metabolic acidosis);

    - severe renal failure (oligo or anuria) in the absence of the possibility of renal replacement therapy;

    - uncorrected violations of the water-electrolyte balance, such as hypokalemia and hypotonic dehydration;

    - Decompensated heart failure;

    - acute pulmonary edema;

    - hyperhydration.

    Carefully:

    Care should be taken when prescribing the drug to patients with a violation of fat metabolism (for example, in renal failure, compensated diabetes, pancreatitis, mild to moderate liver function disorder, hypothyroidism with hypertriglyceridemia and mild to moderate sepsis).

    Pregnancy and lactation:

    Pregnancy

    Data on the use of Lipofundin MST / LST 10% during pregnancy and the possibility of penetration through the placental barrier are insufficient. The available data do not indicate a direct or indirect adverse effect on the course of pregnancy and intrauterine development of the fetus, childbirth and the puerperium.The use of the drug during pregnancy is possible if the expected benefit to the mother exceeds the risk to the fetus.

    Breastfeeding period

    The experience of using Lipofundin MST / LST 10% in the period of breastfeeding is absent. Currently, there is insufficient information about the possibility of isolating Lipofundin MST / LST 10% with breast milk. As a rule, breast-feeding during parenteral nutrition is not recommended.

    Dosing and Administration:

    Mode of application

    Intended for intravenous injection into peripheral and central veins. The temperature of the emulsion to be introduced must correspond to room temperature.

    Fat emulsion can be administered separately as one of the constituent parts of complete parenteral nutrition.

    The maximum daily dose can be introduced only by stepwise increase under careful control of the infusion tolerance.

    Depending on the energy needs of the patient, the following doses are recommended:

    Adults and children from 6 years old

    1-2 grams of lipids / kg of body weight / day, which corresponds to 10-20 ml / kg of body weight / day.

    Newborns (up to 28 days)

    2-3 g (up to 4 g) lipids / kg body weight / day, which corresponds to 20-30 ml (up to 40 ml) / kg body weight / day.

    The ability to excrete lipids in premature and newborns with low body weight is not sufficiently developed. Therefore, the doses should be selected individually, and the concentration of triglycerides and fatty acids in the blood plasma should be carefully monitored.

    Children from 29 days to 5 years inclusive

    1-3 grams of lipids / kg of body weight / day, which corresponds to 10-30 ml / kg of body weight / day.

    Infusion rate

    FROMthe incidence of fat emulsion infusionth should be as low as possible and in the first 15 minutes of infusion should not exceed 0.05-0.1 g of lipids / kg of body weight / h, which corresponds to 0.5-1.0 ml / kg of body weight / h.

    Maximum infusion rate

    Up to 0.15 g of lipids / kg of body weight / h, which is up to 1.5 ml / kg of body weight / h. Accordingly, the rate of administration should not exceed 0.5 drops / kg body weight / min.

    This means that for a patient with a body weight of 70 kg, the maximum infusion rate is approximately 100 ml / h or 35 drops / min.

    The rate of infusion should be reduced in depleted patients and in children. It is recommended to choose such infusion rate at which the calculated daily dose is administered for about 24 hours, but not less than 16 hours.

    Duration of application

    Within the framework of complete parenteral nutrition Lipofundin MST / LST 10% is usually given within 1-2 weeks. If parenteral nutrition with the use of fat emulsions is indicated for a longer period, the period of administration of Lipofundin MST / LST 10% can be increased by appropriate laboratory control.

    Side effects:

    The following systemic adverse reactions are indicated, which may be associated with the use of Lipofundin MST / LST 10%. If the recommendations for use are observed, they develop very rarely (<1/10000).

    Violations of the blood and lymphatic system

    Very rare: hypercoagulable.

    Immune system disorders

    Very rare: allergic reactions.

    Disorders from the metabolism and nutrition

    Very rare: hyperlipidemia, hyperglycemia, metabolic acidosis.

    These adverse side reactions are dose-dependent and therefore occur more often with a relative or absolute overdose of the drug. The incidence of these adverse reactions is less than 1/10000 when the drug is administered in strict accordance with the instructions, observing the dosing regimen and monitoring the correct and safe administration of the drug.

    Disturbances from the nervous system

    Very rare: drowsiness.

    Vascular disorders

    Very rare: increase or decrease in blood pressure.

    Disturbances from the respiratory system, chest and mediastinal organs

    Very rare: shortness of breath, cyanosis.

    Disorders from the gastrointestinal tract

    Very rare: nausea, vomiting.

    General disorders and disorders at the site of administration

    Very rare: headache, hot flashes / erythema, fever, sweating, chills, pain in the back and chest, fat overload syndrome.

    In case of adverse adverse reactions or an increase in the concentration of triglycerides in the blood plasma above 3 mmol / L in adults and 1.7 mmol / L in children, it is necessary to reduce the dose or stop the infusion.

    When re-introduction, especially at the beginning of the infusion, careful monitoring of the patient's condition is required.

    Triglycerides of blood plasma should be monitored with increased frequency.

    The syndrome of fat overload

    Violation of the ability to dispose of triglycerides, which can be caused by an overdose, can lead to a syndrome of "fat overload." It is necessary to monitor for the early detection of symptoms of metabolic overload.The syndrome of fat overload can be a genetic etiology (individual differences in metabolism), in addition, the fat metabolism can be influenced by existing or transferred diseases. This syndrome can also develop against a background of severe hypertriglyceridemia, even with the recommended infusion rate, as well as against the development of severe complications such as kidney failure or infection. The fat-congestion syndrome is characterized by hyperlipidemia, fever, fat infiltration, hepatomegaly (with or without jaundice), splenomegaly, abdominal pain, weakness, anemia, leukocytopenia, thrombocytopenia, blood clotting disorder, hemolysis and reticulocytosis, normative functional tests of the liver and coma . Symptoms are reversible and usually disappear after discontinuation of the infusion.

    In case of signs of fat overload syndrome, the administration of Lipofundin MST / LST 10% should be immediately stopped.

    Overdose:

    Symptoms

    The fat overload syndrome can be the result of prolonged administration of fat emulsion in patients with triglyceride disruption.

    An overdose of a fat emulsion containing medium chain triglycerides, especially without the concomitant administration of solutions of carbohydrates, can lead to metabolic acidosis.

    Treatment

    In case of an overdose, an immediate cessation of the infusion is indicated. Further therapeutic measures depend on the specific symptoms and their severity. In the case of resumption of infusion after the removal of symptoms, the rate of administration should increase gradually under constant observation of the patient's condition.

    Interaction:

    Heparin causes a temporary increase in lipoprotein lipase activity in blood plasma. Initially, this can lead to increased lipolysis in the plasma, followed by a temporary decrease in the concentration of triglycerides.

    Soybean oil contains vitamin K1. However, its content in the Lipofundin MST / LST preparation is 10% so low that there is no significant effect on blood coagulation in patients receiving indirect anticoagulants-coumarin derivatives. Nevertheless, in patients receiving anticoagulants, coagulogram monitoring is necessary.

    Lipofundin MST / LST 10% can not be used as a carrier of electrolyte solutions or othermedicinal preparations, it is impossible to mix with other solutions for infusions without preliminary check of compatibility, as in this case stability of a fat emulsion can not be guaranteed.

    Do not mix Lipofundin MST / LST 10% with alcohol-containing injectable or infusion solutions.

    Special instructions:

    Lipofundin MST / LST 10% should always be part of the parenteral nutrition regimen, which includes the administration of amino acids and carbohydrate solutions. Nausea, vomiting, lack of appetite and hyperglycemia are symptoms that are the basis for prescribing parenteral nutrition or are often present in patients who have parenteral nutrition.

    When you administer Lipofundin MST / LST 10%, you need to monitor the concentration of triglycerides in the blood plasma. If the patient is suspected of having a disorder of fat metabolism, the initial hyperlipidemia with a plasma triglyceride concentration of more than 3 mmol / L in adults and above 1.7 mmol / L in children should be eliminated before the infusion begins. Hypertriglyceridemia 12 hours after the administration of the drug indicates a violation of the metabolism of fats.

    Depending on the state of the patient's metabolism, transient hypertriglyceridemia or an increase in the concentration of glucose in the blood plasma can develop. If the concentration of triglycerides in the plasma during the administration of fat emulsion exceeds the above limit values ​​for adults and children, it is recommended to reduce the infusion rate. If the concentration of triglycerides in the plasma remains above 3 mmol / l, administration should be suspended until the normal concentration of triglycerides in the blood plasma.

    When prescribing fat emulsions to newborns and children under 1 year old, bilirubin can be displaced from the bond with albumin. This effect is due to long chain triglycerides.

    Violations of the water-electrolyte balance, such as hypokapaemia and hypotonic dehydration, should be corrected by administering fluid and electrolytes in the required amounts before the onset of parenteral nutrition. It is necessary to control the electrolytes, the balance of fluid or body weight, acid-base equilibrium, the concentration of glucose in the blood plasma, and for long-term use - the cellular composition of the blood, coagulogram and liver function.

    Hypersensitivity reactions to any component of Lipofundin MST / LST 10% (eg, traces of protein in soy bean oil or egg lecithin) are extremely rare, but can not be completely ruled out in sensitized patients. For any of the symptoms of an allergic reaction (eg, high fever, chills, rash or dyspnea), immediately stop the infusion of Lipofundine MST / LST 10% (or any other fat emulsion).

    Overdose can lead to a syndrome of fat overload.

    Fat emulsion can reduce the accuracy of laboratory tests (eg, bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood samples are taken during or immediately after the infusion of the drug. In most patients, lipids disappear from the bloodstream 5-6 hours after the infusion is complete.

    The use of fat emulsions as the only energy source can trigger the emergence of metabolic acidosis. Simultaneous use of solutions of carbohydrates prevents the development of this complication. Thus, the infusion of fat emulsion should always be combined with the introduction of sufficient amounts of carbohydrate solutions or preparations containing amino acids and carbohydrates.

    The vitamin E, which is part of the preparation, affects the effectiveness of vitamin K, which is involved in the synthesis of clotting factors. This must be taken into account when prescribing the drug to patients with blood clotting disorders or suspected vitamin K deficiency.

    Lipofundin MST / LST 10% contains 2.6 mmol sodium / l. This should be taken into account in patients on a salt-free diet.

    If filters are used when injecting the drug, they must be fat-permeable.

    When the emulsion is administered simultaneously with amino acids and carbohydrate solutions, Y-shaped or by-pass connectors should be located as close to the patient as possible.

    Before introducing fat emulsion together with other solutions through Y-shaped or by-pass connectors, it is necessary to check the compatibility of these preparations. Particular caution should be exercised when combined with solutions that contain divalent electrolytes (eg, calcium).

    Bottle for single use. The remaining unused quantities of the drug should be discarded.

    Shake well before use.

    The emulsion should only be used if, after shaking, it is uniform and the bottle is not damaged.

    Before use, visually assess the uniformity of the emulsion.
    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the ability to drive vehicles, mechanisms, as well as engage in potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Emulsion for infusions, 10%.
    Packaging:

    For 100 ml, 250 ml and 500 ml in bottles of hydrolytic glass class 2, sealed with a rubber stopper of gray color and an aluminum cap of red color with a flange (European Pharmacopoeia).

    For 10 bottles with an equal number of instructions for use in a cardboard box (for hospitals).

    Storage conditions:

    Store at a temperature not exceeding 25 ° C. 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:П N012675 / 01
    Date of registration:30.12.2011
    The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp13.03.2016
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