H Essentsiale® 250 mg / 5 ml 5's solution for injection in ampoules

The instruction for medical use of Essentsiale® medicine H the Trade name of Essentsiale® of N the International unlicensed name Is not present the Dosage form Solution for intravenous administration 250mg/5ml Structure 5 ml of solution contain active agent - essential phospholipids (phosphatidylsincaline from soybeans, the content of dry matter of 93% (3-sn-fosfatidil) sincalines) 298.92 mg (250 mg), excipients: benzyl alcohol, acid dezoksikholiyevy, sodium chloride, sodium hydroxide (granules), Riboflavinum (B2 vitamin), water for injections. Description Transparent yellow solution. Pharmacotherapeutic group Drugs for treatment of diseases of a liver. The ATX A05BA code the Pharmacological Pharmacokinetics Pharmacokinetics properties of parenteral Essentsiale® form H it was studied by a radioactive method. After intravenous administration of a single dose marked hyzone of the essential phospholipids (EFL) which are generally containing linolic acid noted embedding of radioactivity in fraction of kephalin, sphingomyelin and lysolecithin. Among neutral fractions of lipids, marked EFL, apparently, are quicker built in free fatty acids, than in ethers of cholesterol or triglycerides and are brought to bodies, mainly, in a liver. Capture of the entered letsitin fatty tissue and erythrocytes was not defined. After intravenous administration the elimination half-life made 60 days. Removal of less than 10% of marked substances happened to excrements, through kidneys and respiratory organs within 5-7 days after introduction of a dose. It is supposed that the rest marked is transformed by hyzone of essential phospholipids in a liver for biosynthesis of HDL (HVP, cholesterol of high density) and other fractions of lipoproteins. The pharmacodynamics In diseases of a liver occurs death of hepatocytes that conducts to an exit of liver enzymes and increase in their activity in blood serum. The chemical structure of the phospholipids which are contained in Essentsiale® of N is similar that of endogenous phospholipids, however thanks to high content in them polyunsaturated (essential) fatty acids, phospholipids in structure of Essentsiale® of N are more active. High-energy molecules of phospholipids, being built in structure of membranes of hepatic cells, increase regeneration of their membranes. Thanks to features of chemical structure of essential phospholipids, existence cis-double (arrangement of hydrocarbon chains on one side from double bonds) bonds in polyunsaturated fatty acids of cellular membranes interferes with consolidation of structure of fatty acids. It leads to bigger fluidifying of structure of membranes that is necessary for optimum performance of the majority of cells in an organism. By means of this mechanism, essential phospholipids influence those parts of cells which are receptors for hormones or neurotransmitters, thus, metabolic rate, especially lipids amplifies. Phospholipids interfere with the broken lipidic exchange by regulation of metabolism of lipoproteins so that neutral fats and cholesterol turn into the transported forms and that is especially important, it occurs due to increase in capacity of capture of cholesterol lipoproteins of high density and can thus, lead to its oxidation. Exogenous molecules of phospholipids the antioxidant properties and property to take free radicals authentically protect lipids from reoxidation, that is suppress an oxidizing stress and reduce damage of cells. Essential phospholipids reduce products of peroxide of hydrogen in hepatic microsomes and increase concentration of reduced glutathione in a liver and plasma. Intravenous administration of Essentsiale® solution H improves enterohepatic circulation of bile acids at patients from the liver broken by function. Phospholipids have deep impact on structure and a course of bile. During excretion of phospholipids bile the risk of formation of gallstones decreases and the composition of bile is stabilized. Indications as a part of complex therapy - fat dystrophy of a liver (steatosis) - acute and chronic hepatitis - an alcoholic liver disease - medicinal damage of a liver - toxic hepatitis - cirrhosis - hepatic encephalopathy - a cholestasia and prevention of a recurrence of formation of gallstones - the significant changes of functional trials of a liver in gestoses of pregnant women to Adults and children from 12 years enter the Route of administration and doses intravenously slowly on 5-10 ml, in hard cases of 10-20 ml a day. Maximum single dose of 10 ml, maximum daily dose of 20 ml. Frequency rate of introduction 1-2 times a day. Children are from 3 to 6 years old on 2 ml a day, children are from 6 to 12 years old on 2-5 ml a day. It is recommended to begin treatment with intravenous administration of Essentsiale® of N at a severe disease, then to pass to oral administration in the form of the Essentsiale® capsules forte N. Prodolzhitelnost of treatment is defined with clinical laboratory indicators by the doctor and can make from 5 days to 10 days. At will solution can be dissolved with the patient's blood in the ratio 1:1. It is necessary to avoid mixing in one syringe Essentsiale® H with other drugs! Solution cannot be entered intramusculary as possibly irritation of fabrics in the injection site. It is impossible to enter Essentsiale® solution H subcutaneously. At infusion of Essentsiale® of N dissolve in 5% glucose solution. It is impossible to part in solutions of electrolytes (normal saline solution of sodium of chloride, Ringera solution, etc.). All solutions with Essentsiale® of N have to have rn mixes not lower than 7.5, ready solution during introduction of an injection has to keep transparency. Side effects Very seldom - allergic reactions in the form of a dieback or rash, a small tortoiseshell Frequency is unknown - naggers Protivopokazaniya - hypersensitivity to phosphatidylsincaline and/or to one of drug components - children's age up to 3 years, including newborns and premature babies, owing to the content of benzyl alcohol - the lactation period Medicinal interactions Are possible medicinal interactions of Essentsiale® of N with anticoagulants. For this reason, it is necessary to adjust an anticoagulant dose. In case of a concomitant use, the patient has to consult with the doctor. Special instructions At use of Essentsiale® of N the potential risk of allergic reaction to phospholipids from soybeans is possible. Drug contains trace amounts of ethanol (0.6 percents by volume) since alcohol is used in the course of technological production. When prescribing the drug containing benzyl alcohol, to newborns and premature babies development of fatal Gasping of the syndrome resulting from toxic effect of benzyl alcohol is possible (see. Contraindications). Pregnancy Intravenous Essentsiale® solution H contains benzyl alcohol since its penetration into a placenta is possible, drug has to be appointed with care during pregnancy. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Administration of intravenous Essentsiale® solution H does not affect ability to driving of motor transport and work with the equipment. Overdose Currently of reactions of overdose or symptoms of intoxication in connection with use of solution for intravenous administration Essentiale Н®, is not registered. The form of release and packing On 5 ml of drug spill in ampoules from brown neutral glass of I type, with a tag for opening. On 5 ampoules place in blister strip packagings. 1 planimetric packing together with the instruction for medical use in the state and Russian languages is put in a pack from cardboard by Storage conditions to Store at a temperature from 2 °C to 8 °C. To store out of children's reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer Producer balk the Famar Helskeyr product servises Madrid, S.A., Spain (Avda. de Leganes n 62, 28925 Alcorcon Madrid, Spain) the Releasing quality control and the packer of JSC Khimpharm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 the Owner of the registration certificate of Sanofi, France the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) and responsible for post-registration observation of safety of medicine in the territory of the Republic of Kazakhstan: Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187B phone number: 8 (727) 244-50-96 fax: 8 (727) 258-25-96 e-mail:
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