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Dosage form: & nbspsolution for intravenous administration
Composition:

1 ml of the drug contains Active substance: Phospholipids (in terms of phosphatidylcholine) - 50 mg

Auxiliary substances: Benzyl alcohol 9 mg; deoxycholic acid - 23 mg; sodium chloride - 2.4 mg; sodium hydroxide 2,4 mg; riboflavin sodium phosphate (in terms of riboflavin) 0.1 mg; ethanol 96% - 3.3 mg; water for injection up to 1 ml.

Description:Transparent or almost transparent solution of yellow color.
Pharmacotherapeutic group:Hepatoprotective agent
ATX: & nbsp
  • Combination of drugs for the treatment of diseases of the liver and biliary tract
  • Pharmacodynamics:
    Essential phospholipids are the main elements of the structure of the cell membrane and cellular organelles. In diseases of the liver, there is always damage to the membranes of the liver cells and their organelles, which leads to disturbances in the activity of the enzymes and receptor systems associated with them, impairment of the functional activity of the hepatic cells, and a decrease in the ability to regenerate.
    Phospholipids, which are part of the preparation, correspond in their chemical structure to endogenous phospholipids, but exceed the endogenous phospholipids by activity due to the higher content of polyunsaturated (essential) fatty acids in them.The incorporation of these high-energy molecules into the damaged parts of the cell membranes of hepatocytes restores the integrity of the hepatic cells, promotes their regeneration. Since cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains of phospholipid membranes, the density of phospholipid structures is weakened, which increases the metabolic rate. The resulting functional blocks increase the activity of enzymes fixed on the membranes and promote the normal, physiological pathway of the most important metabolic processes. Phospholipids, included in the drug, interfere with impaired lipid metabolism by regulating the metabolism of lipoproteins in such a way that neutral fats and cholesterol pass into transportable forms, mainly by increasing the cholesterol-binding capacity of high-density lipoproteins, and thus may be susceptible to oxidation . Thus, there is a normalizing effect on the metabolism of lipids andproteins; on the detoxification function of the liver; on the restoration and preservation of the cellular structure of the liver and phospholipid-dependent enzyme systems, which ultimately prevents the formation of connective tissue in the liver.
    In the excretion of phospholipids in bile the lithogenic index decreases and bile stabilizes.


    Pharmacokinetics:
    Linking mainly with high-density lipoproteins, phosphatidylcholine enters, in particular, into liver cells. The half-life of the choline component is 66 hours, and the unsaturated fatty acid is 32 hours.

    Indications:
    Fatty degeneration of the liver (including diabetes mellitus); acute and chronic hepatitis, cirrhosis of the liver, necrosis of liver cells, hepatic coma and precoma, toxic lesions, liver; toxicosis of pregnancy; pre- and postoperative treatment, especially in operations in the area of ​​the hepatobiliary zone; psoriasis (as an auxiliary therapy); radiation sickness.

    Contraindications:
    Hypersensitivity to the components of the drug, children under 3 years old (the drug contains benzyl alcohol).

    Carefully:Child age is more than 3 years; pregnancy
    Pregnancy and lactation:

    In pregnancy, due to the presence of benzyl alcohol in the formulation, which can penetrate through the placental barrier (the use of drugs containing petrol alcohol, in neonatal or preterm infants born in time was associated with the development of shortness of breath in fatal cases), the drug can only be used in cases where the expected benefit of therapy for the mother exceeds the potential risk to the fetus.

    Do not recommend to apply during the period Breastfeeding in connection with the lack of data on the safety of the drug.

    Dosing and Administration:
    The drug is intended for intravenous administration, it should not be administered subcutaneously and intramuscularly due to possible local irritation reactions. In the absence of other recommendations, the drug should be injected intravenously slowly by 5-10 ml (1-2 ampoules) per day, in severe cases - from 10 to 20 ml (2-4 ampoules) per day. At a time, it is permissible to administer up to 10 ml (2 ampoules) of the drug. It is recommended to dilute the preparation with the patient's blood in a ratio of 1: 1. If it is impossible to use the patient's own blood, a 5% or 10% dextrose solution for electrolyte infusion, in a ratio of 1: 1, should be used to dilute the drug.The duration of treatment is determined individually by the doctor and can range from 2 - 5 days to 10 - 20 days.
    The drug can be injected according to the doctor's indications, at a speed of 40-50 cap / min, dissolving in 250-300 ml of 5% dextrose.
    The diluted drug solution should remain clear throughout the administration time. It is recommended that parenteral administration by oral administration of the drug be replaced as soon as possible.
    Do not mix in the same syringe with other medicines. Do not dilute in 0.9% solution of sodium chloride and Ringer's solution!
    Side effects:
    To assess the frequency of side effects, the following definitions are used: very often (> 1/10), often (> 1/100 - <1/10), not often (> 1/1000 - <1/100), rarely (> 1 / 10000 - <1/1000), very rarely (<1/10000), unknown frequency (it is impossible to determine the frequency of occurrence from the available data).
    From the digestive system
    It is rarely possible to develop diarrhea when used in high doses.
    From the immune system
    In rare cases, due to the content of benzyl alcohol in the formulation, it is possible to develop reactions of hypersensitivity.
    In very rare cases, skin allergic reactions are possible (rash, exanthema or urticaria). Unknown frequency: itching
    Overdose:No information
    Interaction:No information
    Special instructions:To dilute the solution for intravenous administration, electrolyte solutions should not be used. Use only clear solutions
    Form release / dosage:
    Solution for intravenous administration 50 mg / ml.
    Packaging:
    For 5 ml of the drug in ampoules from light-protective, neutral glass. 5 ampoules are placed in a contour plastic package (tray) made of a polyvinylchloride film or a polyethylene terephthalate film. Five ampoules are placed in a contour mesh box made of a polyvinylchloride film or a polyethylene terephthalate film and aluminum foil printed lacquered or packaging material. 1, 2 contour plastic packages (pallets) or contoured cell packs with ampoules, together with the instruction for use and the ampoule or ampoule ampoule with a knife, are placed in a pack of cardboard.

    5, 10 ampoules, together with the instructions for use and a knife ampoule or scarifier ampullum is placed in a pack with a separating insert of cardboard. If you use ampoules with a colored break point and a notch or a colored ring, the ampoule opener or ampoule ampoule opener is not inserted.

    Packing for hospitals

    50, 100 contour plastic packages (pallets) or contoured cells with ampoules together with instructions for use are placed in a box.
    Storage conditions:
    In the dark place at a temperature of 2 to 8 C.
    Keep out of the reach of children.

    Shelf life:
    3 years.
    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000605
    Date of registration:21.09.2011/10.09.2014
    Date of cancellation:2016-09-21
    The owner of the registration certificate:BINERGIYA, CJSC BINERGIYA, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp28.10.2015
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