Essentiale N solution for injection 250mg/5ml ampoules 5ml №5

Essentiale N solution for injection 250mg/5ml ampoules 5ml №5

Product Code: 8581
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Composition

active substance: 1 ml contains "Essential phospholipids"= EPL- substance (phospholipids from soybeans (93% (3-sn-phosphatidyl) of choline) that contain a-tocopherol, 96% ethanol) - 50 mg

excipients:benzyl alcohol, deoxycholic acid, sodium chloride, sodium hydroxide, Riboflavin (e 101), water for injection.


Dosage form

Solution for injection.


drug description

Hepatotropic preparations. PBX code A05V A.

Reading

non - Alcoholic steatohepatitis, alcoholic steatohepatitis, acute and chronic hepatitis of various etiologies, liver cirrhosis, pre-and postoperative treatment for surgical intervention on the liver and biliary tract, pregnancy toxicosis, psoriasis, radiation syndrome.

Contra

hypersensitivity to the components of the drug.

EssentialeH should not be prescribed to newborns and premature infants, because the preparation includes benzyl alcohol.

Method of application and doses

Adults and children over 12 years of age are prescribed intravenously slowly 5-10 ml per day, and in severe cases - from 10 to 20 ml per day. 10 ml of the drug can be administered at a time. If the drug is administered divorced, it is recommended to use the patient's own blood and breed the drug in a ratio of 1: 1. Infusion is usually used for up to 10 days.

as early as possible to maintain (add) parenteral therapy capsules EssentialeForte N.

the General course of treatment is 3-6 months.

Treatment of psoriasis begins with taking 2 capsules EssentialeForte N 3 times a day for 2 weeks. After that, 10 intravenous injections of 5 ml with simultaneous administration of PUVA-therapy are recommended.

after the end of the course of injections resume taking capsules and continue to use the drug for 2 months.

Side effects

in some cases, the use of elevated doses EssentialeH may be violations of the gastrointestinal tract (diarrhea).

In rare cases there may be hypersensitivity reactions, rash, itching, hives, and reactions at the injection site of the drug.

Overdose

reports of overdose have not been recorded.

Use in pregnancy and lactation

due to the limited amount of clinical trial data for use by pregnant women and due to the presence of benzyl alcohol in the composition that can pass through the placental barrier, EssentialeH is not recommended during pregnancy and lactation.

The

Children

solution EssentialeH for injections can not be assigned to newborns and premature infants, because the composition of the drug is benzyl alcohol. Introduction to infants and premature babies of drugs containing benzyl alcohol, accompanied by the development of shortness of breath syndrome with fatal outcome ( "gasping syndrome", the symptoms of which are sudden onset of shortness of breath syndrome, arterial hypotension, bradycardia and cardiovascular collapse).

the Drug is intended for use in children 12 years of age and approximate body weight of 43 kg (see Section "Method of application and dosage").

Special safety precautions

Use only a clear solution.

the Preparation is incompatible with electrolyte solutions (physiological sodium chloride solution, ringer solution, etc.).

Should not be mixed in the same syringe with other drugs.

the Drug should be slowly injected into the vein (intravenously).

solution EssentialeH for injections can not be injected into the muscles (intramuscularly), because it can lead to local irritation.

Caution:the solution EssentialeN for injection contains 0.6% of alcohol (by volume).

application Features

when diluting EssentialeH for the preparation of an infusion solution (if it is impossible to use the patient's own blood) should be used solutions free of electrolytes, namely: 5% or 10% glucose solution (in a ratio of 1: 1), 5% xylitol solution.

can Not be administered intramuscularly because of the possible occurrence of local irritation.

The

Ability to influence the reaction rate when driving motor transport or operating other mechanisms

Not found.

Interaction with other medicinal products and other forms of interaction.

you Cannot use electrolyte solutions for cultivation of the drug.

The

Pharmacological properties

Pharmacodynamics.in diseases of the liver membrane of hepatocytes and their organelles always experience damage that can lead to changes in the activity of membrane-associated enzymes and receptor systems, disorders of the metabolic functions of the cells and decrease the intensity of regeneration of the liver.

the Phospholipids contained in Essentiale drugN, by its chemical structure similar to endogenous phospholipids, but far outweigh them due to the high content of polyunsaturated (essential) fatty acids. These high-energy molecules are mainly embedded in the structure of cell membranes and facilitate the restoration of damaged liver tissues. Since CIS-double bonds of these polyenic acids prevent the parallel arrangement of hydrocarbon chains of membrane phospholipids, the density of phospholipid structures decreases, resulting in the rate of receipt and removal of substances increases. Membrane-bound enzymes form functional units that can increase their activity and to provide the physiological course of metabolic processes. Phospholipids affect lipid metabolism by the regulation of lipoprotein metabolism, resulting in the neutral fats and cholesterol are converted into forms suitable for transportation, especially due to the increasing ability of high-density lipoproteins (HDL) attach to cholesterol, and forwarded for further oxidation. At the conclusion of phospholipids through bile duct lithogenic index decreases and there is a stabilization of bile.

Pharmacokinetics.oral administration of more than 90% of the drug is absorbed in the small intestine. The main amount is split under the action of phospholipase - a to 1 acyl-LYSO-phosphatidylcholine, 50% of which is immediately reacylated in polyunsaturated phosphatidylcholine during absorption in the small intestine. Polyunsaturated phosphatidylcholine enters the blood through the lymphatic pathways and then, mainly in combination with HDL, is transported to the liver. The maximum content of phosphatidylcholine in the blood 6-24 hours after oral administration is an average of 20%.

the half - life of the choline component is 66 hours, for saturated fatty acids it is 32 hours.

In the course of investigations of the kinetics in the human body is less than 5% of each of the introduced isotopes3N and14deduced from faeces.

Basic physical and chemical properties

transparent yellow solution practically free from visible suspended particles.

The

shelf Life

3 years.

storage Conditions

keep out of reach of children. Store in original packaging at a temperature of + 2 ° C to + 8 ° C.

The

Packaging

No. 5: to 5 ml in an ampoule; for 5 ampoules in a contour acheikova packing in a cardboard box.

The

Category vacation

According to the recipe.

The

Manufacturer

JSC "Halychpharm", Ukraine.

The

Location

Ukraine, 79024, G.. Lviv, St Opryshkivska, 6/8.

trade license Holder

OOO "Sanofi-Aventis Ukraine", Ukraine.

injection of ESSENTIALE N 250MG/5ML

Essentiale H solution for injections 250 mg/5 ml ampoules on 5 ml No. 5 is a hepatotropic drug. The drug significantly increases the resistance of the liver to various pathological effects, enhancing the detoxifying properties of the body.

Assignment

the Preparation is used for:

    The
  • Steatohepatitis (nonalcoholic and alcoholic).
  • The
  • Hepatitis.
  • The
  • Radiation syndrome.
  • The
  • Psoriasis.
  • The
  • toxicosis in pregnant women.

the mechanism of action of the drug is based on the embedding of high-energy molecules into the structure of cell membranes, contributing to the restoration of damaged tissues in the liver. The composition of the drug includes benzyl alcohol, whereby the drug is carefully prescribed to newborn babies and pregnant women.

dosage and how to use

the Drug is administered intramuscularly or intravenously. The recommended dosage for adults is 5-10 ml (1 to 2 vials) per day. Before the introduction of the drug, the content of the ampoule must be diluted in a glucose solution (5%). The course of therapy on an individual basis should determine the therapist, depending on the nature of the disease and the severity of the disease. When overdosing the drug may appear different allergic reactions.

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