Resalut® Pro (Rezalut® pro)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspcapsules
Composition:

For 1 capsule:

Contents of the capsule:

active substance: Lipoid PPL 600 - 600 mg consisting of: phospholipids polyunsaturated from soya lecithin - 300.0 mg, glycerol mono / dialkonate (C14-C18) - 120.0 mg, medium chain triglycerides - 40.5 mg, soybean oil refined - 138,5 mg, α-tocopherol - 1.0 mg;

auxiliary substance: soybean oil, purified - 100.0 mg.

Capsule shell:

gelatin (in terms of dry matter) - 220.5 mg, glycerol 85% - 107.8 mg.

Description:

Transparent, colorless gelatin capsules oblong in shape. Contents of the capsules: a viscous liquid from a golden yellow to a yellowish-brown color.

Pharmacotherapeutic group:hepatoprotective agent
ATX: & nbsp
  • Preparations for the treatment of liver diseases
    • Pharmacodynamics:

    The extract of soybean phospholipids consists of phosphatidylcholine and phosphoglycerides (an average of 76%); while linoleic acid prevails from fatty acids.

    Hepatoprotective action of the drug is due to the acceleration of the regeneration of liver cells and the stabilization of cell membranes, inhibition of the oxidation of lipids and suppression of collagen synthesis in the liver.

    The drug normalizes lipid metabolism, reducing the level of cholesterol by increasing the formation of its esters and linoleic acid.

    Pharmacokinetics:

    Studies of the pharmacokinetics of phosphatidylcholine have shown that it disintegrates in the intestine before lysophosphatidylcholine and is absorbed, mainly in the same form. In the intestinal wall, its resynthesis to a phospholipid partially occurs, which then passes through the lymphatic vessels into the circulatory bed, part of the lyso- phosphatidylcholine disintegrates in the liver to fatty acids, choline and glycerin-3-phosphate. In plasma, phosphatidylcholine and other phosphoglycerides bind strongly to lipoproteins and / or albumin. Most of the introduced soybean phospholipids with a high content in them (3-sn-phosphatidyl) -choline is combined in the form of metabolites, with its own phospholipids of the body for several hours. Their excretion corresponds to the excretion of the body's own phospholipids or their metabolites.

    Indications:

    - Fatty degeneration of the liver of various etiologies; chronic hepatitis; toxic liver damage, liver cirrhosis;

    - hypercholesterolemia with ineffectiveness of diet and other non-drug measures (physical activity and weight loss measures).

    Contraindications:

    - Hypersensitivity to phospholipids, peanuts, soy and other components of the drug;

    - antiphospholipid syndrome.

    Carefully:Children under 12 years.
    Pregnancy and lactation:

    Data on the safety of the drug during pregnancy are absent. Therefore, use of Resolyut® Pro should only be used if the intended benefit to the mother exceeds the possible risk to the fetus.

    Data on the penetration of Resalute® Pro into breast milk are not available, therefore, if you need to use Resalyut® Pro during lactation, breastfeeding for the period of taking the drug should be discontinued.

    Dosing and Administration:

    The drug is intended for oral administration.

    If there are no other indications, you should take 2 capsules of Resolyut® Pro 3 times a day before meals without chewing and drinking with a sufficient amount of liquid.

    The duration of treatment depends on the course of the disease.

    Side effects:

    From the gastrointestinal tract: sometimes there may be discomfort in the epigastric region, diarrhea.

    Allergic reactions: in rare cases, skin rash, hives.

    On the part of the hematopoiesis system: extremely rare - petechial rashes, bleeding in women in the intermenstrual period.

    Overdose:

    No reports of overdose and drug intoxication have been reported so far.

    Interaction:

    Cases of incompatibility have not been known to date.

    However, it is impossible to exclude the interaction of Resalute® Pro with coumarin anticoagulants (for example, fenprocumone, warfarin).

    If the appropriate combination therapy is inevitable, it may be necessary to adjust the dose of the drug.

    Special instructions:

    In one capsule of Resalyut® Pro, there is less than one OD XE (bread unit).

    Effect on the ability to drive transp. cf. and fur:Unknown.
    Form release / dosage:Capsules.
    Packaging:For 10 or 20 capsules in a contour mesh package (blister) [PVC / PVDC / aluminum foil].
    For 1, 3, 5 blisters for 10 capsules or 5 blisters for 20 capsules together with instructions for use in a cardboard bundle.
    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep the medicinal product out of the reach of children.
    Shelf life:

    2 years.

    Do not use after the expiration date stated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-007221/08
    Date of registration:10.09.2008
    The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany
    Information update date: & nbsp21.02.2016
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