Essentiale n - instructions for use. Essentiale n, solution for intravenous administration Injections into the vein of Essentiale

Essentiale in ampoules is considered one of the most effective medicines based on essential phospholipids (international generic substance). The main action of the active substance is aimed at protecting and regenerating the liver after the influence of toxic substances and alcoholic metabolites. Violation of the functioning of the body leads to serious chronic and structural diseases, so it is necessary to complete a full therapeutic course. Patients are administered Essentiale intravenously. This ensures maximum medicinal effect and fast action. In diseases such as cirrhosis or hepatitis of the liver, it is necessary to use a solution for intravenous administration, since capsules or tablets do not provide such an effect.

In any form of the drug contains phospholipids, which are extracted from natural soybeans of the dried substance. The human body is not able to synthesize this substance, so it is extremely necessary for it to receive it from the products of consumption.

These beneficial substances, derived from polyunsaturated fatty acids, have the following therapeutic effects:

Slow down the formation of fibrous-connective tissues in the liver ducts. Such actions help prevent cirrhosis of the liver.
They have a choleretic effect, which prevents the formation of sand or stones in the biliary system.
They contribute to the active production of special enzymes that break down alcohol metabolites and toxins.
They improve the metabolism of proteins and lipids, maintaining them in a soluble state.
Participate in the transport of fats, fatty acids and cholesterol. Dissolve bad cholesterol, which clogs blood vessels.
Provide flexibility of membrane structures and their integrity. Repair damaged liver cells.
They have a beneficial effect on the entire nervous system, ensuring the constant transmission of signals from neurons to the brain.
Support the functioning of the digestive tract.
They have a weak antioxidant effect. The effect of aging becomes less noticeable due to the improvement of the skin.
Increase insulin sensitivity.
Accumulate excess glucose in the liver.

Such a therapeutic effect favorably affects the work of almost all body systems, and also helps the liver to resist toxic substances.

Indications for use

Based on the therapeutic effect provided, Essentiale in ampoules is prescribed for the following indications:

Viral hepatitis of any type that is accompanied by jaundice. The disease is transmitted parenterally, through the blood and other body fluids of humans. Acute and chronic hepatitis primarily affects the cells of the liver parenchyma, so essential phospholipids help restore the structure of hepatocytes and help strengthen the membrane protection of the organ.
allergic manifestations. Rashes, itching, swelling and other manifestations of allergies may indicate liver pathology. Therefore, with diseases of the organ, all unpleasant symptoms can intensify.
Hypothyroidism. Thyroid disorders can affect liver function. There is a sharp deterioration in the biochemical parameters of the organ.
Fatty liver or steatosis. The process is associated with the replacement of healthy liver cells with adipose tissue. The disease causes severe toxic damage to the organ and some conditions of the body (obesity, overnutrition, antibiotics).
Cirrhosis of the liver. Chronic pathology arising from severe damage to the membrane structures of the organ. It is characterized by the replacement of parenchyma cells with fibrous connective tissue. At the same time, there is a decrease in the size of the liver and a change in its structure.
Liver failure. With damage to the parenchyma of the organ, a violation of certain liver functions is observed, the consequences of which are metabolic disorders, intoxication and hepatic coma.
Dyslipidemia. This pathology can occur in a person of any age. A characteristic feature of hyperlipidemia is an increased amount of lipids in the human bloodstream.
Psoriasis. Liver pathologies affect the pathogenesis of skin diseases such as psoriasis. Conversely, acute forms of skin diseases can lead to severe liver intoxication.

Injections of the drug are also given to patients before surgery, when surgery is required on the liver or another organ of the biliary system, and after it, as maintenance therapy.

Despite the fact that the composition of the drug contains natural ingredients, the drug is still contraindicated for certain groups of people. These are patients with increased susceptibility to one of the components.

In such cases, people experience allergic manifestations in the form of a rash, itching, swelling and other symptoms. Therefore, the doctor stops the drip of the drug through a vein and prescribes treatment with another agent.

There are many substitutes for Essentiale, which differ in the active substance and may be suitable for allergy sufferers.

The tool is also contraindicated in newborn children. The child is at great risk due to the alcohol content, which can lead to serious violations in the development of the baby and death. When feeding a baby, it is forbidden to use the drug, because after the introduction into the body, the toxic substance enters the breast milk.

Side effects

The drug is well tolerated by the human body and only in rare cases the following side effects occur:

Dyspeptic disorders of the stomach and intestines. A person periodically experiences nausea and vomiting, which disappear after the solution is removed. Diarrhea or constipation may also occur. In the latter case, the doctor prescribes an inexpensive laxative, which can be found in any pharmacy.
Redness at the injection site. A slight irritation may appear along with the rash. Therefore, injections are recommended only in cases where the patient is not allergic to one of the components of the drug.
Discomfort in the stomach and intestines. Unpleasant sensations may be accompanied by bloating and flatulence. Sometimes increased gas formation can be observed throughout the entire treatment course. In such cases, the doctor prescribes drugs that remove the unpleasant effect.

As a rule, side effects occur at the time of administration of the drug and 1 hour after that. When combining several drugs together with Essentiale, side effects may become more pronounced.

For skin diseases, including psoriasis, the duration of taking Essentiale is determined by a dermatologist or other attending physician. From the beginning of treatment, Essentiale Forte N capsules are prescribed, which the patient must take within 2 weeks. After that, you should switch to intravenous administration of ampoules.

Careful planning and adherence to the course is required. After 10 injections, a course of oral capsules begins, which are taken for 60 days.

The following points must be taken into account:

dosage of capsules and ampoules;
it is necessary to properly dilute the substance (in a 5% glucose solution, but in no case in saline);
slow introduction of the substance;
pre-treat the injection area and monitor the sterility of the syringe.

Another essential condition is the introduction. The drug must not be administered intramuscularly or subcutaneously, this can cause severe tissue irritation and reduce the pharmacological effect. In cases where it is necessary to administer several drugs at once, droppers are used, which are placed by specially trained personnel.

The difference is only the form of release of the drug. Essentiale N is an intravenous ampoules containing 250 mg of phospholipids. A Essentiale Forte N - capsules for oral administration, which, in turn, contain 300 mg of active ingredient.

In addition to dosages, dosage forms of drugs differ in indications and contraindications for use. Alcohol-free capsules are suitable for pregnant and lactating women for the treatment of toxicosis and other diseases.

This dosage form is also used for the prevention of various hepatic pathologies. Ampoules are best purchased directly by prescription from a doctor who will indicate the correct dilution and dosage.

If there are no ampoules in the pharmacy, then they can be replaced with ampoules of the Russian drug - Phosphogliv lyophilisate. This is an analogue of Essentiale N, which contains the same amount of essential phospholipids. The cost per drug will vary slightly.

Capsules can also be replaced by other names. German drug "Doppelgerz asset". Essential phospholipids, according to people, are well suited as a prophylactic agent for the threat of developing cirrhosis, alcoholic hepatitis and other liver diseases. The name of the drug speaks for itself. The description indicates 290 mg of phospholipids and additional B vitamins, which compensate for the lack of nutrients and improve metabolic processes.

Use during pregnancy and lactation

Special attention should be paid to pregnant women. The use of a dropper with a substance can adversely affect the development of the fetus. The benefit of the remedy must outweigh the potential risk. This is due to the fact that Essential contains benzyl alcohol, which crosses the placenta and can cause abnormalities in the development of the baby. In such cases, the doctor should prescribe a safer remedy.

Breastfeeding women are not recommended to use the drug due to the occurrence of a syndrome characterized by respiratory failure and asthma attacks in infants. A mixture of breast milk and molecules of the substance enters the body of the child, where it begins to act immediately. Therefore, a woman needs to stop breastfeeding for the period of treatment or switch to a safer remedy.

Ampoules "Essentiale N" are used in pediatrics in certain dosages, which depend on the age of the child and his weight. As for adults, the solution is used as an additional treatment for serious liver pathologies. It can be viral hepatitis of various types, severe intoxication, impaired liver function.

The official instructions say that the drug is used in the usual dosages for children over 12 years old who weigh more than 40 kg. In such cases, the dosage and duration of therapy is determined by the doctor. h based on the diagnosis.

Starting from 3 years, the daily intake of the drug is 2 ml or less. After 6 years, doses are increased to 5 ml per day. Do not exceed the indicated dosages, since the children's body is much weaker and it is difficult for him to cope with the alcohol contained.

In individual cases, the pediatrician decides to use the drug for the treatment of a child under 1 year old.

These are situations when the baby has:

severe intoxication due to the use of antibiotics and other drugs that have a detrimental effect on the liver;
infectious viral diseases that primarily affect the liver;
hemolytic disease of the newborn, when there is incompatibility of the blood of the mother and fetus.

It is forbidden to independently start treating a child with the help of ampoules, since a preliminary examination of the baby is necessary.

Before you start injecting Essentiale in ampoules, you should carefully read the instructions for use, which tells you how to properly store the liquid for injection. The description states that the ampoules should be stored at a temperature of 2-8°C. This is an important point to which attention should be paid.

In a home refrigerator, the temperature varies from place to place. It is much warmer on the upper and side shelves, so it is better to place the drug on the lower shelves. If you can automatically set the temperature, then it is better to set it to 4-5 ° C, which is suitable for storing funds and food. You should also monitor the physical properties of the substance so that it does not change color or become cloudy.

Shelf life is indicated on the packaging and in the official instructions. The drug should be stored for three years from the date of manufacture.

Influence on the ability to drive a car

In clinical practice, patients did not experience negative effects when using the drug in car drivers. The tool is absolutely safe for driving and performing other work that requires attention and quick response.

Even a small amount of alcohol contained in ampoules does not affect the reaction rate and the nervous system as a whole. But in cases where the patient is given a dropper with a solution, it is better to rest for 30 minutes, after which you can drive.

Interaction with other drugs

The interaction with many drugs of Essentiale N ampoules has not yet been fully studied, so doctors do not recommend using several different medications at the same time. It is better to withstand a period of time (1-2 hours).

This is due to the fact that the active substance can harm people with chronic diseases of the heart, blood vessels or other organs. The drug is able to enter into biochemical reactions and affect the action of other drugs.

Clinical studies have been conducted with anticoagulants. The effect of drugs that reduce blood clotting and prevent the formation of blood clots was enhanced when used together with essential phospholipids.

Therefore, people with diseases such as arterial or venous thrombosis should use Essentiale N ampoules with caution. You must first consult with your doctor so that he gives his permission.

Dosage form

The solution for intravenous administration is clear, yellow.

Compound

dried soybean phosphatidylcholine containing 93% (3-sn-phosphatidyl)choline (synonymous with "essential" phospholipids, EPL®) 250 mg

Excipients: benzyl alcohol (45 mg), deoxycholic acid (115 mg), sodium chloride (12 mg), sodium hydroxide (11.5 mg), riboflavin (0.5 mg), α-tocopherol (0.75 mg), ethanol (16.304 mg) , water d / i (4543.68 mg).

Pharmacodynamics

Hepatoprotector. In case of violation of liver metabolism, the drug ensures the supply of high-energy "essential" phospholipids, ready for assimilation, which are ideally combined with endogenous phospholipids in chemical structure and penetrate into liver cells, penetrating into their membranes.

"Essential" phospholipids normalize liver function and enzymatic activity of liver cells, reduce the level of energy costs of the liver, promote the regeneration of liver cells, convert neutral fats and cholesterol into forms that facilitate their metabolism, stabilize the physicochemical properties of bile.

Pharmacokinetics

Data on the pharmacokinetics of the drug are not provided.

Side effects

Very rarely, with the introduction of high doses of Essentiale® N, gastrointestinal upset (diarrhea) may occur.

Selling Features

prescription

Special conditions

Only clear solution should be used.

Indications

Fatty degeneration of the liver (including with diabetes mellitus);

Acute and chronic hepatitis;

Cirrhosis of the liver;

Necrosis of liver cells;

Hepatic coma and precoma;

Toxic damage to the liver;

Toxicosis of pregnancy;

Pre- and postoperative treatment, especially during operations in the hepatobiliary zone;

Psoriasis;

radiation syndrome.

Contraindications

Hypersensitivity to the components of the drug.

The solution for intravenous injection should not be used to treat children under the age of 3 years (due to the benzyl alcohol included in its composition).

drug interaction

The drug interaction of the drug is not described.

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Essentiale N is a hepatoprotector containing essential phospholipids as an active ingredient, which, in turn, are the basis of cell membranes and organelles. Liver diseases are almost always accompanied by damage to these structures of the liver cells, which entails a whole trail of unpleasant consequences, such as: a violation of the activity of enzymes and receptor blocks, a deterioration in the "technical and tactical" characteristics of liver cells and a decrease in their ability to recover. The phospholipids that make up Essentiale H are almost identical to the body's own phospholipids, with a small but significant exception: they are much richer in polyunsaturated fatty acids, which makes them more active. Embedding in defective areas of the cell membranes of liver cells, phospholipids contribute to their regeneration, increase the fluidity and elasticity of cell membranes, and stimulate metabolism. Thus, there is a normalization of the course of all the most important metabolic processes.

Metabolism is regulated, among other things, through the transfer of cholesterol and neutral fats to their sites of oxidation. This is due to the ability of phospholipids to bind high density lipoproteins to cholesterol. As a result, the metabolism of proteins and lipids is streamlined, the ability of the liver to cleanse the body of toxic products is restored, the energy consumption of this organ is reduced, the physicochemical properties of bile are stabilized, and hepatocytes and liver enzyme systems are not only preserved, but also regenerated.

Essentiale H is used intravenously, while the introduction should be slow. According to general recommendations, the daily dose of the drug is 5-10 ml or 1-2 ampoules. In especially severe cases, it can be doubled. Two ampoules can be administered at a time, however, mixing the drug in one syringe with other drugs is not recommended. Before the introduction, it is advisable to perform such a therapeutic trick: mix the patient's blood with the contents of the syringe in a ratio of 50 to 50. The injection of Essentiale H is optimally supplemented with the intake of an encapsulated form, which is called Essentiale Forte, and the sooner this is done, the better. Before injection, it is necessary to examine the contents of the ampoule in daylight. Attention: the drug can only be used if it is transparent (taking into account its special storage conditions, if not observed, irreversible changes may occur).

Pharmacology

Essential phospholipids are the main structural elements of the cell membrane and cell organelles. In liver diseases, there is always damage to the membranes of liver cells and their organelles, which leads to disruption of the activity of enzymes and receptor systems associated with them, a deterioration in the functional activity of liver cells and a decrease in the ability to regenerate.

The phospholipids that make up the preparation correspond in their chemical structure to endogenous phospholipids, but surpass endogenous phospholipids in activity due to their higher content of polyunsaturated (essential) fatty acids. The incorporation of these high-energy molecules into damaged areas, cell membranes of hepatocytes restores the integrity of liver cells, promotes their regeneration. The 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 cell membranes of hepatocytes is “loosened”, which leads to an increase in their fluidity and elasticity, and improves metabolism. The resulting functional blocks increase the activity of enzymes fixed on the membranes and ensure the normal physiological course of the most important metabolic processes.

The phospholipids that make up the drug regulate the metabolism of lipoproteins, transferring neutral fats and cholesterol to the sites of oxidation, 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; to restore and preserve the cellular structure of the liver and phospholipid-dependent enzyme systems; which ultimately prevents the formation of connective tissue in the liver.

With the excretion of phospholipids into bile, the lithogenic index decreases and bile stabilizes.

Pharmacokinetics

By binding mainly to HDL, phosphatidylcholine enters, in particular, into liver cells.

T 1/2 of the choline component is 66 hours, and unsaturated fatty acids - 32 hours.

Release form

The solution for intravenous administration is clear, yellow.

Excipients: deoxycholic acid - 126.5 mg, sodium hydroxide - 13.4 mg, benzyl alcohol - 45 mg, sodium chloride - 12 mg, riboflavin - 0.5 mg, water for injection - up to 5 ml.

5 ml - dark glass ampoules with clamp (5) - contour packaging (1) - cardboard packs.

Dosage

The drug is intended for intravenous administration, it should not be administered intramuscularly due to possible local irritation reactions.

The contents of two ampoules can be administered 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 a 5% or 10% dextrose solution is used for infusion administration, and the solution of the diluted drug should remain clear throughout the entire time of administration.

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

Overdose

No data.

Interaction

So far not known.

Side effects

Determining the frequency of side effects: very often (≥1/10), often (≥1/100 -< 1/10), нечасто (≥1/1000 - < 1/100), редко (≥1/10 000 - 1/1000), очень редко (< 1/10 000), частота неизвестна (по имеющимся данным невозможно установить частоту возникновения).

On the part of the immune system: rarely - due to the content of benzyl alcohol in the preparation, hypersensitivity reactions may develop; very rarely - allergic skin reactions (rash, exanthema or urticaria); frequency unknown - itching.

Indications

fatty degeneration of the liver (including diabetes mellitus);
acute hepatitis;
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 during operations in the hepatobiliary zone;
psoriasis;
radiation syndrome.

Contraindications

hypersensitivity to the components of the drug;
children's age up to 3 years.

Application features

Use during pregnancy and lactation

Care should be taken to use Essentiale ® N during pregnancy due to the presence of benzyl alcohol in the preparation, which can penetrate the placental barrier (the use of drugs containing benzyl alcohol in term newborns or premature newborns was associated with the development of dyspnea syndrome with lethal outcome).

Instructions for the medical use of the medicinal product

ESSENTIALE® N

Tradename

Essentiale® N

International non-proprietary name

Dosage form

Solution for intravenous administration 250mg/5ml

Compound

5 ml of solution contain

active substance- essential phospholipids (phosphatidylcholine from soybeans, dry matter content 93% (3-sn-phosphatidyl)choline) 298.92 mg (250 mg),

Excipients: benzyl alcohol, deoxycholic acid, sodium chloride, sodium hydroxide (granules), riboflavin (vitamin B2), water for injection.

Description

Clear yellow solution, practically free of visible suspended particles.

Pharmacotherapeutic group

Drugs for the treatment of liver diseases.

ATC code A05BA

Pharmacological properties

Pharmacokinetics

The pharmacokinetics of the parenteral form of Essentiale® N was studied by a radioactive method. After intravenous administration of a single dose of tritium-labeled essential phospholipids (EPL), mainly containing linoleic acid, incorporation of radioactivity into the fractions of cephalin, sphingomyelin and lysolecithin was noted. Among the neutral fractions of lipids, labeled EPLs seem to be more rapidly incorporated into free fatty acids than into cholesterol esters or triglycerides and delivered to organs, mainly the liver. The capture of the introduced lecithins by adipose tissue and erythrocytes was not determined. After intravenous administration, the half-life was 60 days. Excretion of less than 10% of labeled substances occurred in the feces, through the kidneys and respiratory organs within 5-7 days after dosing. It is assumed that the rest of the tritiated essential phospholipids are transformed in the liver for the biosynthesis of HDL (HVP, high-density cholesterol) or other lipoprotein fractions.

Pharmacodynamics

In liver diseases, the death of hepatocytes occurs, which leads to the release of liver enzymes and an increase in their activity in the blood serum.

The chemical structure of the phospholipids contained in Essentiale® N is similar to that of endogenous phospholipids, however, due to the high content of polyunsaturated (essential) fatty acids in them, the phospholipids in Essentiale® N are more active. The incorporation of high-energy phospholipid molecules into the structure of liver cell membranes increases the regeneration of hepatocyte membranes.

Due to the peculiarities of the chemical structure of essential phospholipids, the presence of cis-double (location of hydrocarbon chains on one side of the double bonds) bonds in polyunsaturated fatty acids of cell membranes prevents the structure of fatty acids from compacting. This leads to a greater liquefaction of the membrane structure, which is necessary for the optimal functioning of most cells in the body. Through this mechanism, essential phospholipids act on those parts of the cells that are receptors for hormones or neurotransmitters, thus increasing the metabolic rate, especially lipids. Phospholipids interfere with impaired lipid metabolism by regulating lipoprotein metabolism so that neutral fats and cholesterol are converted into transportable forms, and most importantly, this occurs by increasing the uptake capacity of HDL cholesterol and can thus lead to its oxidation. Exogenous phospholipid molecules, with their antioxidant properties and ability to capture free radicals, reliably protect lipids from overoxidation, that is, they suppress oxidative stress and reduce cell damage. Essential phospholipids reduce the production of hydrogen peroxide in hepatic microsomes and increase the concentration of reduced glutathione in the liver and plasma.

Intravenous administration of Essentiale® N solution improves the enterohepatic circulation of bile acids in patients with impaired liver function. Phospholipids have a profound effect on the composition and flow of bile. During the excretion of phospholipids by bile, the risk of gallstone formation is reduced and the composition of bile is stabilized.

Indications for use

As part of complex therapy

fatty degeneration of the liver (steatosis)

acute and chronic hepatitis

alcoholic liver disease

drug-induced liver injury

toxic hepatitis

cirrhosis of the liver

hepatic encephalopathy

cholestasis and prevention of recurrent gallstone formation

pronounced changes in liver function tests in gestosis of pregnant women

Dosage and administration

Adults and children from 12 years old administered intravenously slowly at 5-10 ml, in severe cases 10-20 ml per day. The maximum single dose is 10 ml, the maximum daily dose is 20 ml. Frequency rate of introduction 1-2 times a day.

Children from 3 to 6 years old 2 ml per day, children from 6 to 12 years old, 2-5 ml per day.

The duration of treatment is determined taking into account clinical and laboratory parameters by the doctor and can range from 5 days to 10 days.

If desired, the solution can be diluted with the patient's blood in a ratio of 1:1.

It is necessary to avoid mixing Essentiale® N with other drugs in one syringe!

The solution should not be administered intramuscularly, as tissue irritation at the injection site is possible. Do not administer Essentiale® N solution subcutaneously. When infused, Essentiale® N is dissolved in a 5% glucose solution.

Do not dilute in electrolyte solutions (physiological sodium chloride solution, Ringer's solution, etc.).

All solutions with Essentiale® N must have a pH of the mixture of at least 7.5, the finished solution must remain transparent during the injection.

Side effects

Very rarely

Allergic reactions in the form of exanthema or rash, urticaria

Frequency unknown

Contraindications

Hypersensitivity to one of the components of the drug

Children's age up to 3 years

Newborns and premature infants, due to the content of benzyl alcohol

lactation period

Drug Interactions

Drug interactions of Essentiale® N with anticoagulants are possible. For this reason, the dose of the anticoagulant needs to be adjusted.

In case of simultaneous administration, the patient should consult a doctor.

special instructions

When using Essentiale® N, there is a potential risk of an allergic reaction to “phospholipids from soybeans”.

The drug contains trace amounts of ethanol (0.6% by volume), because ethyl alcohol is used in the process of technological production.

Pregnancy

Intravenous solution Essentiale® N contains benzyl alcohol, because. possible penetration into the placenta, the drug should be administered with caution during pregnancy.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

The introduction of an intravenous solution of Essentiale® N does not affect the ability to drive vehicles and work with equipment.

Overdose

To date, overdose reactions or symptoms of intoxication in connection with the use of a solution for intravenous administration of Essentiale N® have not been registered.

Release form and packaging

5 ml solution in ampoules of yellow neutral glass type I.

5 ampoules in a blister pack made of polyvinyl chloride film.

1 blister pack, together with instructions for use in the state and Russian languages, is placed in a cardboard pack.

In group packaging, cardboard packs are placed in cardboard boxes and glued with adhesive tape. A group label is attached to the box.

Storage conditions

Store at temperatures between 2°C and 8°C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer

Bulk product manufacturer

Sanofi Aventis S.A., Spain

(Avda. de Leganes n 62, 28925 Alcorcon Madrid, Spain)

Packed

Chimpharm JSC, Republic of Kazakhstan,

Shymkent, st. Rashidova, w / n

Applicant

Sanofi-aventis Kazakhstan LLP, 050016 Republic of Kazakhstan, Almaty, st. Kunaeva 21 "B".

Address of the organization accepting claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Indications for use

Considering the action provided by Essentiale, injections are prescribed for:

Acute and chronic hepatitis, regardless of their origin.
Fatty hepatic degeneration, which appeared due to various reasons.
Pathology that has arisen due to disorders in the blood circulation of the hepatic vessels and the function of the bile ducts (cirrhosis).
Necrotic processes in cells.
liver failure.
Hepatic precoma and coma.
Hyperlipoproteinemia.
Hypertriglyceridemia.
Violations in the liver, resulting from the development of various diseases.
Toxicosis.
Increased activity of AsAT and AlAT enzymes in pregnant women.
Prevention to prevent the recurrence of gallstones.
Cholestasis (decrease in the flow of bile into the duodenum due to disturbances in the processes of bile formation and excretion).
Psoriasis.

In addition, Essentiale is included in preoperative therapy. Most often, the drug is prescribed before operations on the liver, gallbladder and bile ducts.

In addition to direct indications for the use of Essentiale, there are some other diseases in which injections are used as additional therapy. Among them:

various types of disorders in the work of the cardiovascular system;
malfunctions in the functioning of the digestive system;
skin diseases;
oncological diseases.

Also, the drug is prescribed for preventive purposes to prevent premature aging, reduce intoxication of the body due to poisoning with alcohol and various chemicals.

Contraindications

Essentiale should not be treated in patients who are hypersensitive to at least one of the components (active or auxiliary) that make up the drug. There are also age restrictions:

solution in ampoules is contraindicated in children under 3 years of age;
capsules should not be taken by children under 12 years of age (lack of sufficient evidence).

Despite the fact that Essentiale is contraindicated in early childhood, it is often prescribed to newborns. When I was with a child in the hospital, my 4-day-old baby had a sharp increase in bilirubin, and the skin turned yellow. The pediatrician prescribed Essentiale in capsules. I had to open the capsule to mix its contents with the mixture and give it to my daughter. I can’t say how effective the drug was, but on the 7th day we were discharged with normal skin color. True, in addition to hepatoprotectors, we were prescribed ultraviolet irradiation under a special lamp.

Use during pregnancy and HB (breastfeeding)

Essentiale contains benzyl alcohol, which is able to pass through the utero-placental barrier. This substance, when used regularly by a pregnant woman, allegedly causes dyspnea syndrome in newborns, which leads to death. Due to the fact that this information has not been scientifically proven, the drug is prescribed during pregnancy in special cases, when the help to the mother's body will be significant compared to the harm that can be caused to the fetus.

HB is not a contraindication, so nursing mothers can be treated with Essentiale without fear of harming the baby.

Advantages

In addition, Essentiale is able to positively influence other vital organs and systems of the human body. Additional effects of the drug include:

normalization of metabolic processes in the body;
reduction in the number of atherosclerotic plaques in the vessels and a decrease in their size;
improvement of the clinical picture in case of diabetes mellitus (its manifestations become less pronounced);
improved blood quality (becomes less thick).

As for the difference between various forms, when the drug is injected, it has a stronger and faster effect on the body. Therefore, this variant of the drug is prescribed for the treatment of acute and advanced stages of diseases.

In addition to differences in the forms of administration, drugs also differ in their composition. So, Essential H contains only phospholipids. And the Essentiale preparation is additionally enriched with B vitamins and nicotinamide, which enhance the effect of the main component.

What are hepatoprotectors and are they really effective?

The pharmacological class of drugs that can improve liver function to some extent are called hepatoprotectors. Currently, these drugs are in great demand among the population, because the incidence of liver disease is increasing. You can classify the whole set of hepatoprotectors into two large groups:

synthetic origin, i.e., produced in the laboratory (phospholipids, amino acid derivatives, bile acids);
of plant origin, that is, homeopathic preparations of plant and animal origin (it should be noted that even in the manufacture of the most environmentally friendly preparations, their ingredients are still subjected to minimal chemical processing).

In the medical world, there are still disputes about the effectiveness of hepatoprotectors: the studies conducted regarding the effectiveness of drugs do not satisfy the inquisitive minds of specialists in medicine and pharmacology. The human liver is an organ with a truly fantastic ability to regenerate, which is why many doctors attribute the “effectiveness” of hepatoprotectors to the ability of the organ to self-heal. Thus, a person, taking a medicine and adjusting his diet, is sure that subsequent improvements in clinical results are associated precisely with taking a hepatoprotector. But in fact, liver cells went through a natural cycle and self-repaired.

Laennec

Laennec is an immunomodulator with a hepatoprotective effect. The drug is produced in ampoules. The active components of the agent are able to activate phagocytes. In addition, they prevent the formation of cholesterol deposits. The drug restores the affected hepatocytes

Laennec is used in the treatment of chronic liver diseases. When an organ is damaged, the drug is administered intravenously. The recommended course of treatment is 21 days. Possible adverse reactions with Laennec include numbness and pain at the injection site.

How to take the drug for psoriasis

Careful planning and adherence to the course is required. After 10 injections, a course of oral capsules begins, which are taken for 60 days.

The following points must be taken into account:

dosage of capsules and ampoules,
it is necessary to properly dilute the substance (in a 5% glucose solution, but in no case in saline),
slow introduction of the substance,
pre-treat the injection area and monitor the sterility of the syringe.

Indications for use

Based on the therapeutic effect provided, Essentiale in ampoules is prescribed for the following indications:

Viral hepatitis of any type that is accompanied by jaundice. The disease is transmitted parenterally, through the blood and other body fluids of humans. Acute and chronic hepatitis primarily affects the cells of the liver parenchyma, so essential phospholipids help restore the structure of hepatocytes and help strengthen the membrane protection of the organ.
allergic manifestations. Rashes, itching, swelling and other manifestations of allergies may indicate liver pathology. Therefore, with diseases of the organ, all unpleasant symptoms can intensify.
Hypothyroidism. Thyroid disorders can affect liver function. There is a sharp deterioration in the biochemical parameters of the organ.
Fatty liver or steatosis. The process is associated with the replacement of healthy liver cells with adipose tissue. The disease causes severe toxic damage to the organ and some conditions of the body (obesity, overnutrition, antibiotics).
Cirrhosis of the liver. Chronic pathology arising from severe damage to the membrane structures of the organ. It is characterized by the replacement of parenchyma cells with fibrous connective tissue. At the same time, there is a decrease in the size of the liver and a change in its structure.
Liver failure. With damage to the parenchyma of the organ, a violation of certain liver functions is observed, the consequences of which are metabolic disorders, intoxication and hepatic coma.
Dyslipidemia. This pathology can occur in a person of any age. A characteristic feature of hyperlipidemia is an increased amount of lipids in the human bloodstream.
Psoriasis. Liver pathologies affect the pathogenesis of skin diseases such as psoriasis. Conversely, acute forms of skin diseases can lead to severe liver intoxication.

Alcohol compatibility

The instructions for the Essentiale N ampoules do not indicate that the medicine should not be taken with alcohol, but such a combination is undesirable. The hepatoprotector protects and restores hepatocytes, and the ethyl alcohol contained in alcoholic beverages is toxic to liver cells.

Essentiale is not compatible with alcohol. Cannot be taken at the same time.

An excess amount of phospholipids leads to their accumulation in the liver. At the same time, fatty liver is the main consequence of alcohol consumption for the liver. Thus, in this regard, both phospholipids and alcohol act in the same way - they lead to "fatty liver".

What diseases is the drug indicated for?

Essentiale forte N is prescribed for the following diseases:

chronic hepatitis;
cirrhosis of the liver;
fatty degeneration of the liver of various etiologies;
toxic liver damage;
toxicosis of pregnancy;
psoriasis (as adjuvant therapy);
radiation syndrome.

Cirrhosis of the liver is a disease of the organ, characterized by damage to all structural elements of the liver, the growth of connective tissue in it, and a violation of the functions of the organ; in the treatment of cirrhosis of the liver can help Essentiale

Essentiale H is prescribed in the same cases. But this form of the drug has additional indications. These include not only chronic hepatitis, but also inflammation of the organ in the acute phase, as well as necrosis of its cells. In hepatic coma and precoma, intravenous administration is the only way to deliver drugs to the body. Ampoules are also prescribed to patients who have undergone surgery on the liver or in the area near it.

List of analogues of Essentiale

Contraindications to taking the drug can force the patient to go in search of another high-quality hepatoprotector. The modern pharmacological market offers the following effective hepatoprotectors:

"Heptral" and its analogue, cheaper in cost, "Heptor". Used in the presence of liver damage by viruses and toxins, as well as cirrhosis in the initial stages. The main active ingredient of the drug is ademetionine. It has not only a hepatoprotective effect, but also an antidepressant effect, which is especially important for people with alcohol and drug addiction during the withdrawal period.
"Hofitol". Active ingredients - artichoke and other medicinal plants, the drug has a moderate choleretic and diuretic property, which helps to reduce the load on the liver. "Hofitol" is used for bile insufficiency and in the initial stages of the development of liver pathologies. However, its use in case of blockage of the bile ducts is inappropriate.
"Ursosan". A drug based on ursodeoxycholic acid, which protects the liver from toxins, and also reduces the concentration of bile acids in the systemic circulation. In medical practice, there are many cases when the regular intake of "Ursosan" contributed to the complete dissolution of gallstones. "Ursosan" is effective in hepatitis, steatosis and cirrhosis, as well as gallstone disease.
"Karsil" is a silymarin-based drug that eliminates toxins and is one of the most effective hepatoprotective agents. Its effectiveness has been proven in toxic hepatitis and cirrhosis.

Since the digestive organs are connected with each other, the pathology in one organ leads to a violation in the other. as a rule, if a violation of the functioning of the liver was diagnosed, then the work of the pancreas is not entirely effective. Basically, for the complex treatment of both the liver and the pancreas, preparations with a mild antibacterial effect, herbal and phospholipid preparations are prescribed, such as:

"Ceftriaxone".
"Cefatoxime".
"Liv-52".
"Allohole".

Brief instructions for the use of ampoules

The drug has a yellowish color and is packaged in 5 ml dark glass ampoules. The medicine is injected.

The composition of the drug

The instructions for use of Essentiale in ampoules indicate that the drug contains phospholipids. 5 ml of liquid contains 250 mg of the active substance.

Essentiale also contains inactive components:

deoxycholic acid;
sodium hydroxide;
riboflavin;
benzyl alcohol;
sodium chloride;
water for injections.

Essential phospholipids in the treatment solution are similar in structure to the elements that form the basis of cell membranes and organelles, but contain more polyunsaturated fatty acids. The active substance, received with the blood flow, is built into the structure of the hepatocyte, activating the regenerative ability, and this has a positive effect on the work of the organ.

Why is it administered intravenously?

fatty hepatosis;
hepatitis;
cirrhosis;
necrosis of the hepatic parenchyma;
intoxication in case of poisoning or severe infections;
liver failure;
toxicosis of pregnant women;
recovery in the postoperative period;
radiation syndrome;
psoriasis.

Types of liver failure

Essentiale in ampoules can be prescribed when taking hepatotoxic drugs (anti-tuberculosis, chemotherapy) to prevent liver damage. The drug improves the functions of the organ and protects hepatocytes from destruction.

Doses

Essentiale's solution is done only intravenously at the dose prescribed by the doctor. If there are no special instructions, then put 1 time per day 5-10 ml (1-2 ampoules). In severe hepatic lesions, the volume of the administered medication can be increased to 15-20 ml per day.

How injections are made

Essentiale is administered intravenously by a health worker in a treatment room. Before administration, the drug solution is diluted with the patient's blood. Procedure algorithm:

Take a syringe, which is twice the volume of the prescribed amount of Essentiale solution.
They take the drug.
A tourniquet is applied to the patient on the middle third of the shoulder.
Treat the injection site.
Insert a needle into a vein.
Using a piston, venous blood is drawn into the syringe with the medicine so that the ratio is 1: 1, and then the tourniquet is removed.
Slowly introduce the resulting mixture.

It is allowed to dilute "Essentiale N", instead of blood, with 5 or 10% dextrose. If a dextrose solution is used, then care must be taken to ensure that the mixture remains transparent.

It is forbidden to mix the hepatoprotector with "electrolytes" (saline solution, Ringer's solution) or to inject in the same syringe with other medicines.

Efficiency Study

There are no clinically confirmed data on the benefits of the drug "Essentiale N". But, considering the aspects of effectiveness from the point of view of modern medicine, it should be taken into account that the membranes of hepatocytes are 2/3 composed of phospholipids, and with a lack of this substance in the body, the regeneration of cellular structures is difficult. Essentiale injections make it possible to provide the tissues with the components necessary for cell restoration and due to this, the following occurs:

acceleration of division and growth of hepatic cells;
stimulation of the recovery of damaged hepatocytes;
improved molecular transport;
increased activity of enzyme systems.

Recovery processes are slow and patients do not always immediately feel the positive effect of the drug. In some people, positive dynamics is found only in clinical studies.

Is it possible during pregnancy

The instructions for use of Essentiale indicate that the drug is used to treat toxicosis of pregnant women.

But the expectant mother is given injections with caution because of the benzyl alcohol contained in the Essentiale preparation. The element passes through the hematoplacental barrier and its influence can provoke fetal respiratory failure

Essentiale during pregnancy is used when the health benefits of the pregnant woman are higher than the possible risk of complications in the unborn child. Injections of a hepatoprotector to a woman are done only in a hospital under the supervision of a doctor.

Injections of a pregnant woman are done only in a hospital setting.

special instructions

The manufacturer of the drug warns that:

the agent can be used only if it has retained its transparency during the storage period and remains so during the entire time of administration;
it is impossible to draw Essentiale and some other additional medicine into the syringe.

With parenteral administration of the drug, it is recommended to supplement the treatment with another dosage form intended for oral administration - Essentiale forte N. This remedy is available in the form of capsules. The main components in the composition are phospholipids from soybeans. The drug is intended for adults and children over 12 years of age. The optimal dose is 2 capsules three times a day. It is required to drink medicine during food. There are no restrictions on the duration of use.

For children

Up to 3 years of age, the injection solution is dangerous. Due to Essentiale, shortness of breath syndrome may develop. There is a risk of death.

Use during pregnancy and lactation

During the period of bearing a child, the drug should be used with caution and only as prescribed by the attending physician. Studies have shown that phenylcarbinol penetrates the histohematogenous barrier

Breastfeeding is not a contraindication to the use of the drug.

drug interaction

There were no cases recorded in which, due to the combination of Essentiale and other drugs, undesirable symptoms and consequences would occur.

Experts advise patients to observe the reactions of their body while using the solution and other drugs. Theoretically, negative drug interactions are possible. If you experience any suspicious symptoms, you should contact your doctor.

Essentiale and alcohol

Doctors advise all patients to stop drinking alcohol-containing drinks. Alcohol negatively affects the liver. Its harmful compounds pass through this organ. The liver plays the role of a filter. It rids the body of toxins, but at the same time it is exposed to negative effects. Alcohol destroys liver cells, disrupts the functioning of the organ.

The Essentiale solution is able to restore hepatocytes and the normal functioning of the liver. However, when taken simultaneously with alcohol, the medicine will not give the expected effect.

How to take Essentiale Forte

The duration of the recovery course of the drug is from 2-3 weeks to 2-3 months. It is necessary to take Essentiale Forte until a tangible positive result is achieved. The attending physician determines the optimal regimen for taking the medication for the patient. There are the following dosages taken according to the instructions:

At one time, you need to take 2 capsules (total dose is 600 mg) three times a day. This dosage is recommended for adults and children from 12 years of age and weighing more than 43 kg.
For prevention, take 1 capsule 3 times a day.

Side effects and overdose

The most common side effects after taking Essentiale capsules include the following manifestations on the part of the body:

bloating;
nausea;
discomfort in the abdomen;
diarrhea, diarrhoea.

Extremely rarely in patients after taking the drug Forte, urticaria, pruritus, atopic dermatitis, Quincke's edema were observed. The severity of side effects when taking the medication is usually weak. They appear in most cases with an individual allergic reaction to the components of the drug, an excess dose of the drug (overdose). If you refuse the drug or reduce the number of capsules, the negative consequences quickly pass.

special instructions

The effect of Essentiale Forte has not been established on the ability to drive or use machines. To get a positive result, you need to take the medication regularly, without gaps.

drug interaction

When taking anticoagulants, Essentiale Forte leads to an increase in their action, which should be taken into account by doctors when drawing up a course of treatment. The required dose of drugs will depend on this. It is strictly forbidden to combine the reception of Forte Essentiale with alcoholic beverages. The latter have an extremely detrimental effect on the state of the liver, according to researchers, in combination with hepatoprotectors, the negative effect is enhanced. As a result, the opposite of the expected result is obtained, the transaminase index increases.

Hepa-Merz

This medicinal product is produced both in the form of granules for the preparation of a solution that is taken orally, and as a concentrate for injection. That is why it is not as convenient to use as Essentiale Forte N capsules. Reviews of doctors on the drug "Hepa-Merz" report a narrower range of its use. It is not used for necrosis, hepatocyte dystrophy, psoriasis, radiation syndrome and toxicosis. The course of treatment is much shorter and is no more than 30 days.

"Hepa-Merz" has a completely different principle of operation. It contains two amino acids that provide detoxifying properties to the product. The components of the drug bind ammonia, reducing the effect of toxins on the body. It also has the following effects:

Increases the synthesis of insulin and growth hormone.
Removes dyspeptic, asthenic and pain syndromes.
Normalizes body weight in steatosis and steatohepatitis.
Stabilizes protein metabolism.

The main difference lies in the speed of the drug "Hepa-Merz" and the presence of more contraindications when it is prescribed.

Analogues

Varieties of Essentiale have the same analogues, since they all contain the main active ingredient - phospholipids. However, their analogues are divided into two large groups according to the principle of the presence and absence of additional components in the form of vitamins. Representatives are listed in the table.

Pharmaceutical products are represented not only by those medicines that have a similar active substance, but also by medicines that have a different active ingredient, but a similar therapeutic effect. The alternative is represented by such drugs:

Bonjigar;
Galsten;
Hepatrin;
Heptral;
Hepatomax;
Deepana;
Carnitine;
Karsil;
Liv 52;
Methionine;
Ovesol;
Cholenol;
Hofitol.

Domestic analogues - Antraliv produced by OAO Nizhpharm, Livolife forte produced by ZAO Coral-Med, Phosfonciale produced by ZAO Canonpharma Production.

Inexpensive analogues (Phosfonciale, Rezalyut Pro) can be purchased for 300-400 rubles. Essliver forte and Livolife forte are even cheaper. These medicines do not cross the price maximum of 300 rubles.

2 How to use the drug

Usually, Essentiale in ampoules is administered 2 injections intravenously per day (more accurate doses are determined by the doctor after consultation), but if the patient needs many injections, a dropper (infusion therapy) may be prescribed. For her, the drug is diluted with dextrose and an infusion is carried out with such a solution.

Often, infusion therapy is combined with oral administration of Essentiale Forte. Diseases for which this drug is used:

chronic and acute hepatitis;
cirrhosis of the liver;
alcoholic and non-alcoholic steatohepatosis;
liver failure.

Very often, Essentiale is used for unspecified liver diseases (jaundice of various etiologies, autoimmune hepatitis).

Quite well, the drug showed itself in the complex treatment of liver cancer, after chemotherapy and partial resections of the organ, it very well accelerates its recovery. The drug is often prescribed for maintenance therapy of hepatitis C, where it shows excellent results.

Used to treat alcohol withdrawal, as the drug accelerates the removal of toxins from the body, significantly improves the condition and well-being of the patient. For the same purpose, injections are prescribed in the complex therapy of heavy metal poisoning, they increase detoxification and reduce liver damage. With hemochromatosis, it is used in combination with bloodletting to reduce iron in the blood and stabilize the patient.

The drug practically does not cause adverse reactions, an allergy can only be to benzyl alcohol, which is in ampoules, but even this occurs quite rarely

But nevertheless, there is a chance to buy an expired medication, so you should take into account that the ampoule should contain a clear, slightly yellow solution

Rules for using the Essentiale solution

In order for the drug to bring maximum benefit, it must be used correctly. To do this, you should follow some rules:

Inject only with a clear solution. If, during mixing or during the introduction, the slightest signs of turbidity appear in it, then the procedure must be interrupted, the container with the cloudy contents should be discarded. The rest of the dose of the drug must be administered from another ampoule.
It is impossible to combine Essentiale and other medicines in one syringe.
To dilute the drug, ordinary saline solutions are not used. It must be diluted with the patient's own blood in a ratio of 1:1. Instead of blood, electrolyte-free solutions (5% xylitol, 5 or 10% glucose) may be used. An exception is made only when blood cannot be used.
The drug is administered exclusively intravenously. It cannot be used intramuscularly. It is also impossible to make subcutaneous injections, since there is a high probability of irritation at the injection site.
The medicine is administered very slowly.
If the patient is prescribed a large number of injections, then the injections are replaced by droppers.

Characteristics of the drug

Modern pharmacology presents several forms of medication:

Essentiale;
Essentiale N;
Essentiale forte;
Essentiale forte N.

If it is necessary to use a specific type of drug, doctors specify its trade name, since the drug differs not only in its name, but also in the form of release, chemical composition.

For example, the absence of the prefix "forte" means that the drug is in the form of an injection solution, and its presence indicates that the drug is available in capsules for oral administration. The situation is similar with the letter "N". Its presence in the trade name emphasizes that the composition of Essentiale is represented exclusively by phospholipids, and the absence indicates the inclusion of supplements in the form of vitamins.

In everyday life, patients may call the drug differently. For example, “Essentiale tablets” is the common name for capsule forms, and “Essentiale in ampoules” is a solution for injection.

Essentiale

The drug has the following active ingredients:

phospholipids - 0.25 g;
vitamin B6 - 0.0025 g;
vitamin B12 - 0.0001 g;
nicotinamide - 0.025 g;
vitamin B5 - 0.0015 g.

Essentiale forte

The chemical composition of Essentiale forte is represented by the following active ingredients:

phospholipids - 0.3 g;
vitamin B6 - 0.006 g;
vitamin B12 - 0.00006 g;
nicotinamide - 0.03 g;
vitamin B1 - 0.006 g;
vitamin B2 - 0.006 g;
tocopherol - 0.006.

Phosphogliv

The Russian manufacturer offers a good option at an affordable price, which has a number of differences from the German counterpart Essentiale Forte N. Instructions, reviews of doctors, opinions of patients allow us to think about the similarity of the two drugs

But there are five main differences to look out for:

Despite the fact that the active substance in both cases are phospholipids that can normalize the cell membrane, Phosphogliv also contains glycyrrhizic acid. It is believed that in addition to recovery, it reduces the risk of degeneration of liver fibrosis into cirrhosis, which means that it can be used both for treatment and for prevention, which does not allow the disease to go into a life-threatening stage.
It has been scientifically proven that Phosphogliv works better than analogues that do not contain glycyrrhizic acid. Its effectiveness is 50% higher in the treatment of fatty hepatosis. Studies confirm the improvement in blood counts and the state of the organ by ultrasound.
"Phosphogliv", unlike "Essentiale Forte N", is included in the list of vital and essential medicines. It is used in inpatient treatment and is prescribed under preferential prescriptions.
The cost of the domestic analogue is much lower, which makes it more profitable to purchase a medicine designed for a long course.
An imported drug can be used during pregnancy, so gynecologists prefer to prescribe it.
You can store a domestic drug at temperatures up to 25 degrees. "Essentiale forte N" requires placement in the refrigerator.

Causes and symptoms of liver disease

Why do certain liver pathologies develop?

The reasons, as a rule, are very commonplace and even with varying degrees of liver damage are the same:

regular alcohol abuse; taking narcotic toxic substances (it doesn’t matter whether intravenously or nasally, or orally - the liver experiences a strong load in any case); forced or intentional intake of hepatotoxic drugs; chemotherapy and radiotherapy; violation of the outflow of bile. as well as some other serious diseases of the digestive tract; malnutrition over a long period of time (often fatty degeneration of the liver begins after decades of malnutrition, which is accompanied by obesity, diabetes, etc.)

pharmachologic effect

The main therapeutic effect of the drug depends on the level of phospholipids. Vitamin substances only enhance their action and make up for the deficiency in the human body.

Phospholipids are complex structures that make up the walls of hepatocytes. Deficiency of substances causes a change in the level of permeability of the latter, the entry of unnecessary elements into cells, and premature death of hepatocytes. After the drug enters the body and is absorbed through the walls of the intestinal tract, phospholipids penetrate the bloodstream into the liver, where they take part in the restoration of its structural elements.

Therapeutic effects of the drug:

restoration of hepatocyte membranes;
activation of enzymatic activity;
increased protein and fat metabolism;
increase in glycogen stores;
restoration of detoxification function;
elimination of fatty infiltration of the gland;
normalization of bile composition, restoration of the biliary system.