Эссенциале® N

General characteristics. Structure:

Active agent: phosphatidylsincaline from soybeans of the dried-up substance containing 93% (3-8p-fosfatidil) sincalines: synonyms - essential phospholipids, EPL® - 250,00 mg.
Excipients: desoxycholeic acid - 126,50 mg, sodium hydroxide of-13,40 mg, benzyl alcohol - 45,00 mg, sodium chloride - 12,00 mg, Riboflavinum - 0,50 mg, water for injections - to 5 ml.
Description: Transparent yellow solution.

Pharmacological properties:

Pharmacodynamics. Essential phospholipids are basic elements of structure of a cover of cells and cellular organellas. At liver diseases there is always a damage of covers of hepatic cells and their organellas which leads to disturbances of activity of the related enzymes and systems of receptors, deterioration in functional activity of hepatic cells and decline in the ability to regeneration.
 
The phospholipids which are a part of the drug Essentsiale® forte of N correspond on the chemical structure to endogenous phospholipids, but surpass endogenous phospholipids in activity at the expense of higher content in them polyunsaturated (essential) fatty acids. Embedding of these highly power molecules to the damaged sites of cellular membranes of hepatocytes recovers integrity of hepatic cells, promotes their regeneration. Cis-double bonds of their polyunsaturated fatty acids prevent a parallel arrangement of hydrocarbon chains in phospholipids of cellular covers, the phospholipidic structure of cellular covers of hepatocytes "is loosened" that causes increase in their flowability and elasticity, improves a metabolism. The formed functional blocks increase activity of the enzymes fixed on membranes and promote a normal, physiological way of course of the major metabolic processes.
The phospholipids which are a part of the drug Essentsiale® forte regulate metabolism of lipoproteins, transferring neutral fats and cholesterol to places of oxidation, mainly it occurs due to increase in ability of lipoproteins of high density to contact cholesterol.
Thus, the normalizing effect is had on metabolism of lipids and proteins; on disintoxication function of a liver; on recovery and preservation of cellular structure of a liver and fosfolipidozavisimy fermental systems; what finally interferes with formation of connecting fabric in a liver.
At excretion of phospholipids in bile there is a decrease in a litogenny index and stabilization of bile.

Pharmacokinetics. Contacting mainly lipoproteids of high density phosphatidylsincaline comes in particular to liver cells.
The elimination half-life of a choline component makes 66 hours, and unsaturated fatty acids - 32 hours.

Indications to use:

Fatty degeneration of a liver (including, at a diabetes mellitus); acute and chronic hepatitises, cirrhosis, necrosis of cells of a liver, hepatic coma and prekoma, toxic damages of a liver; pregnancy toxicosis; before - and postoperative treatment, especially, at operations in the field of a gepatobiliarny zone; psoriasis; radiation syndrome.

Route of administration and doses:

Drug is intended for intravenous administration, it should not be entered intramusculary because of possible local reactions of irritation. In the absence of other recommendations of the doctor it is necessary to administer the drug slowly intravenously 1-2 ampoules (5-10 ml) or in hard cases 2-4 ampoules (10-20 ml) a day. Contents of two ampoules can be entered at the same time. Not to mix in one syringe with other medicines. It is recommended to dissolve solution with the patient's blood in the ratio 1:1.
In need of cultivation of drug only 5% or 10% dextrose solution for infusional introduction are used, and solution of divorced drug has to remain transparent during the whole time of introduction.
It is impossible to dissolve drug with electrolytic solutions (isotonic solution, Ringer's solution)!
It is recommended to add, as soon as possible, parenteral administration with oral administration of drug.

Features of use:

To use only transparent solution!

Side effects:

For assessment of frequency of side effects the following definitions are used: very often (> 1/10), it is frequent (> 1/100 - <1/10), is not frequent (> 1/1000 - <1/100), is rare (> 1/10000 - <1/1000), is very rare (<1/10000), the unknown frequency (according to the available data it is not possible to establish emergence frequency).
From immune system
In rare instances because of contents as a part of drug of benzyl alcohol development of hypersensitivity reactions is possible.
Skin allergic reactions (rash, dieback or small tortoiseshell) are seldom or never possible.
Unknown frequency: itch.

Interaction with other medicines:

So far are not known.

Contraindications:

Hypersensitivity to any of drug ingredients. Children's age up to 3 years. With care
At pregnancy, in connection with existence in composition of drug of benzyl alcohol which can get through a placental barrier (use of the drugs containing benzyl alcohol for the newborn or premature newborns born in time was associated at them with development of a syndrome of an asthma with a lethal outcome).

Storage conditions:

At a temperature from 2 °C to 8 °C. To store in the place, unavailable to children. List B. Period of validity 3 years. After a period of validity drug cannot be used.

Issue conditions:

According to the recipe

Packaging:

Solution for intravenous administration of 250 mg / 5 ml.
On 5 ml of drug in an ampoule of dark glass with an overclamping. On 5 ampoules in planimetric packaging from PVC. On 1 planimetric packaging together with the application instruction in a cardboard pack.