Active substancePhospholipidsPhospholipids
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  • Dosage form: & nbspsolution for intravenous administration
    Composition:

    In 5 ml of the drug contains:

    Active substance: phosphatidylcholine from soy bean dried substance, containing 93% (3-sn-phosphatidyl) choline: synonyms -Essential phospholipids, EPL® - 250.00 mg

    Excipients:

    deoxycholic acid - 126,50 mg, sodium hydroxide - 13.40 mg, benzyl alcohol - 45.00 mg, sodium chloride - 12.00 mg, riboflavin - 0.50 mg, water for injection - up to 5 ml.

    Description:

    Transparent yellow solution.

    Pharmacotherapeutic group:Hepatoprotective agent
    ATX: & nbsp

    A.05.C   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 Essentnale H preparation, correspond in their chemical structure to endogenous phospholipids, but exceed the endogenous phospholipids by activity due to a higher content of polyunsaturated (essential) fatty acids. The incorporation of these highly energetic molecules into the damaged sections of the cell membranes of hepatocytes restores the integrity of the hepatic cells, promotes their regeneration. Cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains in the phospholipids of cell membranes, the phospholipid structure of the cellular envelopes of hepatocytes "loosens", which causes an increase in their fluidity and elasticity, improves metabolism.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, which are part of Essential H, regulate the metabolism of lipoproteins, transferring neutral fats and cholesterol to oxidation sites, mainly by increasing the ability of high-density lipoproteins to bind to cholesterol.

    Thus, there is a normalizing effect on the metabolism of lipids and proteins; 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 there is a decrease in the lithogenic index and stabilization of bile.


    Pharmacokinetics:
    Linking, mainly, to 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:

    Fat degeneration, liver (including diabetes mellitus); acute and chronic hepatitis, cirrhosis of the liver, necrosis of liver cells, hepatic coma and precoma, toxic liver damage; toxicosis of pregnancy; pre- and postoperative treatment, especially in operations in the area of ​​the hepatobiliary zone; psoriasis; radiation syndrome.

    Contraindications:

    Hypersensitivity to any of the ingredients of the drug.

    Children under 3 years!

    Carefully:

    In pregnancy, due to the presence in the formulation of petrol alcohol, which can penetrate through the placental barrier (the use of drugs containing benzyl alcohol in newborn babies or premature newborns was associated with the development of dyspnoeal syndrome with a fatal outcome).

    Dosing and Administration:

    The drug is intended for intravenous administration, it should not be administered intramuscularly due to possible local irritation reactions. In the absence of other recommendations of the doctor, the drug should be injected slowly intravenously 1-2 ampoules (5-10 ml) or in severe cases 2-4 ampoules (10-20 ml) per day. The contents of the two ampoules can be entered simultaneously.Do not mix in the same syringe with other medicines. It is recommended to dilute the solution with the patient's blood in a ratio of 1: 1.

    If it is necessary to dilute the drug, only 5% or 10% dextrose solution for infusion is used, the diluted drug solution should remain clear throughout the administration time.

    Do not dilute the drug with electrolyte solutions (isotonic solution, Ringer's solution)!

    It is recommended, as soon as possible, to supplement the parenteral administration by oral administration of the drug.

    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, (by it is not possible to establish the frequency of occurrence).

    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.


    Interaction:

    To date, not known.

    Special instructions:

    Use only clear solution!

    Form release / dosage:

    Solution for intravenous administration of 250 mg / 5 ml.


    Packaging:For 5 ml of the drug in a vial of dark glass with a vomiting. 5 ampoules per circuit pack of PVC. On 1 contour pack together with instructions for use in cardboard pack.
    Storage conditions:

    At a temperature of 2 ° C to 8 ° C.

    Keep out of the reach of children.

    List B.

    Shelf life:

    3 years.

    After the expiration date, the drug can not be used

    Terms of leave from pharmacies:On prescription
    Registration number:П N016326 / 01
    Date of registration:27.04.2010
    The owner of the registration certificate:AVENTIS PHARMA, CJSC AVENTIS PHARMA, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.10.2015
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