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Geptral 500 mg 5’s powder for solution for intramuscular and intravenous injections




The instruction for medical use of GEPTRAL® medicine the Trade name of Geptral® the International unlicensed name Ademetionin Lekarstvennaya a form Powder the Structure lyophilized for preparation of solution for intravenous and intramuscular administration of 500 mg complete with solvent of 5 ml One bottle contains active agent – an ademetionin of 1.4-butandisulfonat 949 mg (500 mg of a cation of an ademetionin are equivalent) excipients: water for injections, nitrogen. One ampoule with solvent contains active agents: A L-lysine of 428.0 mg, sodium hydroxide of 14.4 mg excipient – water for injections. The description the Lyophilized powder The Lyophilized Weight from white till yellowish color, free from foreign particles. Solvent Transparent liquid from colourless till light yellow color. The prepared drug solution – transparent solution from colourless till yellow color without visible deposit. Pharmacotherapeutic group Digestive tract and metabolism. Other drugs for treatment of gastrointestinal diseases and disbolism. Amino acids and their derivatives. Ademetionin. The ATX A16AA02 code the Pharmacological Pharmacokinetics Absorption At properties of the person after intravenous administration a pharmacokinetic profile of an ademetionin is two-phase with a fast phase of distribution in fabrics and clearance with elimination half-life about 1.5 h. Absorption at intramuscular introduction – 96%, the maximum plasma concentration are reached in 45 min. after use. After single dose in kishechnorastvorimy tablets of an ademetionin in doses from 400 to 1000 mg the reached maximum plasma concentration are dose-dependent and make 0.5 – 1 mg/l in 3 – 5 hours. The bioavailability after oral administration increases if ademetionin it is applied on an empty stomach. Plasma concentration decrease to reference values within 24 hours. Distribution the Volume of distribution makes 0.41 and 0.44 l/kg for doses of an ademetionin of 100 mg and 500 mg respectively. Linking with serum proteins insignificant also makes ≤ 5%. Metabolism Process of metabolism of an ademetionin is cyclic and is called a cycle of an ademetionin. At the first stage of this cycle the ademetionin-dependent metilaza uses ademetionin as substrate for products S-adenozil-gomotsisteina which is hydrolyzed then to a gomotsistein and adenosine by means of S-adenozil-gomotsistein-gidralazy. Gomotsistein in turn is exposed to the return transformation to methionine by transfer of methyl group from 5 methyltetrahydrofolates. Finally, methionine can be transformed in ademetionin, finishing a cycle. Removal Normal removal with urine makes 15.5 ± 1.5% in 48 hours and removal with excrements – 23.5 ± 3.5% in 72 hours. A pharmacodynamics of Geptral® (active agent – S-аденозил-L-methionine (ademetionin)) – amino acid of natural origin which is present at all fabrics and fluid mediums of an organism. Гептрал® (ademetionin) first of all also the donor of methyl group in many reactions of transmethylation acts as coenzyme. Transfer of methyl groups (transmethylation) of an ademetionin is a basis at creation of a phospholipidic cell membrane and plays a role in the fluidity of membranes. Гептрал® (ademetionin) it is capable to get through a blood-brain barrier. High concentrations of Geptral (ademetionina) influence the transmethylation processes which are very important in brain fabric thanks to influence on metabolism of catecholamines (dopamine, adrenaline, noradrenaline), indolamines (serotonin, melatonin) and a histamine. Гептрал® (ademetionin) is also a predecessor of biochemical thiol connections (cysteine, taurine, glutathione, coenzyme A, etc.) – in transsulphonating reactions. Glutathione, the most powerful antioxidant, is an important component for a hepatic detoxication. Гептрал® increases glutathione level at patients with damage of a liver of both alcoholic, and not alcoholic genesis. Folic acid and B12 vitamin are essential to – nutrients in metabolism and Geptral’s (ademetionina) accumulation. The intra hepatic cholestasia Drug is effective at treatment of an intra hepatic cholestasia in liver diseases, during pregnancy and other chronic hepatic diseases. The intra hepatic cholestasia is a complication of chronic diseases of a liver and is the reason of damage of hepatic cells. In chronic diseases of a liver such functions of hepatocytes as clearance and regulation of production of bile acids are broken that leads ment of an intra hepatic cholestasia. Use of an ademetionin was studied at patients with the chronic diseases of a liver which are often followed by a vnutripechechny cholestasia: primary biliary cirrhosis, lekarstvenno – the induced damages of a liver, a viral hepatitis, the cholestasia induced by parenteral nutrition, defeats by an alcoholic liver disease and not alcoholic fat alcoholic disease of a liver. Elimination of the fatigue caused by the chronic diseases of a liver (CDL) Ademetionin showed decrease in a symptom of fatigue at HZP. The integrated analysis among subjects with presence of fatigue showed treatment influence ademetioniny not only on fatigue, but also on some other symptoms, such as, a depression, jaundice, an indisposition and an itching. Patients with ALD (alcoholic liver disease) have a treatment ademetioniny improved suppressed mood which was also noted among patients with fatigue. Moreover, at subjects with fatigue against the background of ABP or with NABP (not alcoholic liver disease) at treatment ademetiony jaundice, an indisposition and an itching decreased. A depression of Geptral® (ademetionin) it was applied parenterally and inside to treatment of a depression. Antidepressive action was shown for 5-7 day of treatment in the absence of anticholinergic reactions. An intra hepatic cholestasia of pregnant women Treatment ademetioniny (in/in, in oil, inside in the form of tablets) is effective at an intra hepatic cholestasia of pregnant women and is shown in the form of reduction of a skin itching and improvement of biochemical parameters. Indications – an intra hepatic cholestasia at pretsirrotichesky and cirrhotic states – an intra hepatic cholestasia at pregnancy – a depressive syndrome the Route of administration and doses Treatment can be begun with parenteral administration of drug (intravenously slowly or intramusculary) with the subsequent use of drug in the form of tablets or initially with use of tablets. Tablets should be swallowed entirely, without chewing. For the best absorption of active agent and full therapeutic effect the pill should be taken between meals. The tablet Geptrala should be taken out from the blister just before reception. In case of discoloration of tablets from initial from white to yellowish (owing to damage of an aluminum cover of the blister) it is necessary to refrain from their use. The lyophilized powder for intramuscular or intravenous use is dissolved in special solvent just before use. To throw out the unused rest. For intravenous administration the necessary dose of Geptral should be parted further in 250 ml of normal saline solution or 5% of solution of a dextrose (glucose) and to carry out infusion slowly within 1-2 hours. Гептрал® it is not necessary to mix with alkaline solutions, or with the solutions containing calcium ions. It is not necessary to apply powder in case of change of its color from initial from white to yellowish (owing to damage of a bottle or heating). Adult Initial therapy Intravenous or intramuscular administration: the recommended dose makes 5-12 mg/kg/days intravenously or intramusculary. The usual initial dose makes 500 mg/days intravenously or intramusculary, the general daily dose should not exceed 1000 mg. Duration of initial therapy – 15-20 days at treatment of a depressive syndrome, 14 days – at treatment of an intra hepatic cholestasia at pretsirrotichesky and cirrhotic states, an intra hepatic cholestasia at pregnancy. When performing initial therapy by Geptral in the form of tablets (oral administration): the recommended dose makes 10-25 mg/kg/days. The usual initial dose makes 400-800 mg a day. The daily dose should not exceed 1600 mg. Maintenance therapy: Orally: in a dose of 500-1600 mg/days. Children the Efficiency and safety of use of an ademetionin for children is not established Patients of advanced age. Treatment is recommended to be begun with the smallest recommended dose, in view of decrease in hepatic, renal or warm function, existence of the accompanying morbid conditions and use of other medicines. Use for patients Is recommended to be careful with a renal failure at use of an ademetionin for such patients. Use for patients with a liver failure Pharmacokinetic parameters is normal and at patients with a liver failure are identical. Side effects Side effects from clinical trials Often (≥1/100, & lt, 1/10) – nausea, an abdominal pain, diarrhea – a headache – alarm, insomnia – a skin itching – an asthenia Infrequently (≥ 1/1000, & lt, 1/100) – dryness in a mouth, dyspepsia, a meteorism, gastrointestinal pain, gastrointestinal bleedings, gastrointestinal disorders, vomiting – hypostasis, fever, a fever, reactions in the place of an injection, necrosis in the injection site – hypersensitivity, anaphylactoid reactions or anaphylactic reactions (for example, hyperaemia of integuments, an asthma, a bronchospasm, a dorsodynia, sensation of discomfort in breasts, change of arterial blood pressure (hypotonia, a hypertension) or pulse rate (tachycardia, bradycardia)) – infections of urinary tract – arthralgias, muscular spasms – dizziness, paresthesias, a dysgeusia – excitement, confusion of consciousness – a laryngeal edema – the increased sweating, a Quincke’s disease, skin allergic reactions (for example, rash, a skin itching, a small tortoiseshell, an erythema) – “inflows”, hypotension, phlebitis – an esophagitis Seldom (≥ 1/10000, & lt, 1/1000) – an abdominal distension, an esophagitis – the Contraindication indisposition – hypersensitivity to any component of drug – patients with the genetic disorder influencing metabolism of methionine and/or a homocystinuria and/or a gipergomotsisteinemiya (for example, deficiency of enzyme tsistation beta sintetazy, B12 vitamin metabolism disturbance) Medicinal interactions Was the message about development of a serotoninovy syndrome in the patient applying ademetionin and klomipramin. It is necessary to apply with care Geptral® along with selective serotonin reuptake inhibitors, tricyclic antidepressants (such as klomipramin), the drugs and vegetable means containing tryptophane. The special instructions Geptral® in the form of powder of the solution lyophilized for preparation for intravenous and intramuscular administration of 500 mg complete with solvent less than 1 mmol (23 mg) contain a sodium/dose, that is it is almost free from sodium. Intravenous administration is carried out very slowly. As the deficiency of B12 vitamin and folic acid can lead to decrease in level of an ademetionin, at patients of risk group (with anemia, liver diseases, pregnancy, probability of a vitamin deficiency, in connection with other diseases or a diet, for example, at vegetarians) plasma should carry out standard blood tests for assessment of content of vitamins B. If insufficiency is found, intake of B12 vitamin and/or folic acid prior to treatment or a concomitant use with ademetioniny is recommended. Some patients at therapy ademetioniny can have a dizziness. It is not necessary to run vehicles or to work with other mechanisms before total disappearance of symptoms which can affect speed of response at the specified types of activity. Гептрал® it is not recommended for use for patients with bipolar psychoses. Messages about transition of a depression to a hypomania or mania at treatment were received ademetioniny. Patsiyentov it is necessary to warn about need of informing the doctor if during therapy by Geptral the symptoms of their disease (depression) do not pass or worsen. Patients with a depression need careful observation and continuous mental health services at treatment ademetioniny for the purpose of control of efficiency of treatment. Messages about the tranzitorny or amplifying alarm at the patients receiving treatment Geptraly (ademetioniny) were received. In most cases, the treatment termination was not required. In certain cases the alarm stopped after a dose decline or the termination of therapy. Ademetionin interacts with immunoassays for definition to a gomotsistein that can lead to false increase in level of a gomotsistein in blood plasma at the patients receiving treatment Geptraly (ademetioniny). At this category of patients it is recommended to use not immunological methods of determination of level of a gomotsistein in blood plasma. The liver failure of Dose adjustment is not required. It is necessary to control ammonia level at patients with a giperammoniyemiya. The renal failure of Geptral® to apply with care. Use in pediatrics Safety and efficiency of use of Geptral (ademetionina) for children up to 18 years are not established. Pregnancy and the period of a lactation Geptral’s Use in І a trimester of pregnancy is possible only in urgent cases. In the period of a lactation of Geptral® it is applied, only if the advantage of its use exceeds risk for the baby. Features of influence of medicine on ability to run vehicles or potentially dangerous mechanisms there Can be dizziness. It is not necessary to run vehicles or to work with other mechanisms before total disappearance of symptoms which can affect speed of response at the specified types of activity. Overdose Symptoms – strengthening of side effects. Treatment – the general maintenance therapy against the background of observation of vital functions of an organism and a clinical condition of the patient. The form of release and packing place Drug in the glass bottles corked by the rubber bungs which are pressed out by aluminum caps with plastic lids. On 5 ml of solvent place in ampoules from hydrolytic glass. On a bottle and an ampoule paste the label self-adhesive. On 5 bottles with drug and on 5 ampoules with solvent pack into blister strip packaging (intermediate packing) from a film of polyvinylchloride and aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack from cardboard with the applied holographic logo image of the Abbott company. To Store storage conditions at a temperature not above 25 °C. To store out of children’s reach! 3 years not to apply a period of storage after expiry date. On secondary packing (cardboard pack of a set) the date of production of medicine corresponds to date of production of powder. The expiration date of drug is defined concerning that component (the powder lyophilized or solvent) which expiration date expires earlier. Prescription status According to the prescription the Producer of Bayolodzhisi Italy Laboratories of Neuter of l., Italy Via Filippo Serpero – 20060 Masate (MI) the Owner of the registration certificate of Abbott Laboratories GmbH, Hanover, Germany the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine: Abbott Kazakhstan LLP 050059 Almaty, Dostyk Ave., 117/6, BC Han Tengri – 2 ph.: +7 727 2447544, fax: +7 727 2447644

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