Metakartin 1 g/5 ml solution for injection 5's

The instruction for medical use of Metakartin Torgovoye medicine a name Metakartin Mezhdunarodnoye the unlicensed name Levokarnitin Lekarstvennaya a form Solution for injections, 1.0 g / 5.0 ml Structure of 5 ml of drug contain active agent - a left carnitine of 1.0 g, excipients: acid chlorohydrogen to rn 6.2-6.6, water for injections up to 5.0 ml. Description Transparent colourless solution. Pharmacotherapeutic group Other drugs for treatment of gastrointestinal diseases and disbolism. Amino acids and their derivatives. Levokarnitin. The ATX A16AA01 code the Pharmacological Pharmacokinetics Later properties of intravenous administration a left carnitine easily gets into all fabrics, high concentrations are created in skeletal muscles and a myocardium. The maximum concentration in blood plasma is maintained within 9 hours. Does not contact proteins of plasma and albumine of the person. After parenteral administration the left carnitine minimum is exposed to metabolism. It is removed by kidneys, mainly in the form of acylic ethers, in quantity directly proportional to left carnitine level in blood plasma. Elimination half-life makes 17.4 hours. It is removed by kidneys (76% in 24 hours). Metakartin's pharmacodynamics - drug for correction of metabolic processes. A left carnitine - natural substance, related to group B vitamins. Participates in processes of a metabolism as the carrier of fatty acids through cellular membranes from cytoplasm in a mitochondrion where these acids are exposed to process of β-oxidation with formation of a large amount of energy (in the form of ATP). Releasing coenzyme A, the left carnitine strengthens receipt of metabolites in a tricarbonic acid cycle. On the same mechanism it stimulates activity of pyruvatedehydrogenase in skeletal muscles and oxidation of branched amino acids. Drug normalizes proteinaceous and lipometabolism, restores an alkaline reserve of blood, formation of ketonic acids and anaerobic glycolysis oppresses, reduces degree of a laktatsidoz and also increases physical activity and increases shipping of physical activities, at the same time promotes economical expenditure of a glycogen and increase in its stocks in a liver. Indications - primary (genetic) and secondary deficit of a carnitine - secondary deficit of a carnitine at patients, it is long receiving a hemodialysis and having the following symptoms: expressed constant muscular spasms, weakness of skeletal muscles, myopathies, loss of muscle bulk, symptoms of arterial hypotension, anemia, cardiomyopathy, lack of treatment response or need of high doses of erythropoietin. The route of administration and doses Solution for injections Metakartin is intended for slow intravenous administration (within 2-3 minutes) For definition of an optimum dose it is recommended to control therapy, measuring levels of a free and acylic left carnitine in blood plasma and urine. Level of a free left carnitine in blood plasma there have to be 35 - 60 µmol/l. The ratio of an acylic left carnitine to the level of a free left carnitine in blood plasma has to be not higher than 0.35. The dose is calculated depending on age and body weight. At primary and secondary deficit of a carnitine the recommended doses depend on disbolism and degree of manifestation during treatment. Metakartin solution for injections, is entered intravenously slowly within 2-3 minutes, at the same time the daily dose is divided into 3-4 introductions, or in the form of infusion: intravenously by drop infusion, slowly about 3 ml a minute (or no more than 60 drops a minute), at the rate of 30 min. on 100 ml and 1 hour 20 minutes on 250 ml. Before introduction the necessary dose of drug is dissolved in 100 or 250 ml of isotonic solution of sodium of chloride or 5% of solution of glucose. To children up to 12 years (including to newborns and babies) In the majority a case the recommended dose makes 100-200 mg/kg/days. If clinical and biochemical indicators do not improve, the dose can be increased for a short time. High doses up to 400 mg/kg/days can be necessary at a sharp metabolic decompensation. Adults and children are more senior than 12 years At primary or secondary deficit of a left carnitine in case of a sharp decompensation drug appoint 50-100 mg/kg/days in a dose. If necessary use of drug in higher dose is possible, however it is connected with high risk of development of side reactions. At secondary deficit of a carnitine at a hemodialysis the drug is administered intravenously slowly (within 2-3 min.). To children up to 12 years drug appoint in a dose 10-20 mg/kg/days upon termination of each procedure of a hemodialysis (when holding three procedures of a hemodialysis in a week). To children 12 years on 1g/days and adult 2 g/days upon termination of each procedure of a hemodialysis are more senior. The dose of 2.5 g is appointed to the patients who are on a hemodialysis more than 1 year. Duration of intravenous treatment is no more than 3 months, it is the period necessary for restoration of normal level of maintenance of a left carnitine in muscles. Need of a repeated course of treatment is defined by the maintenance of a left carnitine in blood plasma which control should be carried out regularly. Side effects - nausea, vomiting, an abdominal pain, diarrhea at long reception of an oral left carnitine, - muscle weakness, spasms at patients with uraemia, - allergic reactions (itching of skin, skin rash, a small tortoiseshell, a Quincke's edema, an acute anaphylaxis), - a specific smell of a body. Reduction of a dose often weakens or eliminates the unpleasant corporal smell caused by drug at the patient and gastrointestinal symptoms., - at fast introduction the appearance of the pains on the course of a vein passing at reduction in the rate of introduction is possible. Contraindications - hypersensitivity to a left carnitine or auxiliary components of drug. In the form of solution for infusions the drug Metakartin is contraindicated to patients with a hyper natremia and a hypervolemia. Solution for infusion with solvent glucose is contraindicated to patients with diabetes. Medicinal interactions Prescribing of the drug Metakartin, solution for injections, to patients with the diabetes receiving insulin or oral hypoglycemic drugs can cause a hypoglycemia owing to increase in digestion of glucose. Therefore at this category of patients during drug treatment, it is necessary to control constantly glucose level in blood plasma for correction of the mode of dosing of hypoglycemic drugs. At simultaneous use the glucocorticosteroids promote accumulation of drug in fabrics (except a liver). Lipoic acid, anabolic steroids enhance effect of a left carnitine. It is necessary to inform the attending physician about uses of any other drugs together with Metakartin. Reception of a carnitine can increase the content of free valproic acid in blood serum and by that to exponentiate its action even at reception sredneterapevtichesky the dosed Reception of overdoses of sincaline can reduce activity of a carnitine. The special instructions Drug does not cause accustoming or dependence as L – a carnitine a natural component of an organism. The tolerance of drug should be controlled within the first week of treatment and after each increase in a dose. If you passed a dose, do not accept a double dose, continue treatment as usual. Intravenous administration of drug has to be slow (2-3 minutes). Metapictures, solution for injections, should take with caution the patients having chronic heart failure, an acute renal failure in the hypostases caused by a delay of salts and also to the patients taking the corticosteroid and corticotropic hormonal drugs. Long reception without additional intake of potassium can lead to a hypopotassemia. Drug is used with care at patients with burdened allergoanamnezy. As the carnitine improves digestion of glucose, it is necessary to control its level in blood serum at patients with diabetes. Metakartin to patients with heavy disturbances of functions of kidneys or being on dialysis in an end-stage of a renal failure does not lead intravenous administration of high doses to accumulation of potentially toxic metabolites of trimethylamine (TMA) and trimetil-N-oxide (TMAO) which are usually allocated with urine. This situation is observed at chronic ingestion in high doses. Pregnancy and the period of a lactation Metakartin, solution for injections, appoint only in emergency cases, having carefully compared advantage for mother and potential risk for a fruit or the child. Features of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms of the Person which note muscle weakness after use Metakartin, solution for injections have to refrain from driving and potentially dangerous mechanisms. Overdose High doses of a left carnitine can cause diarrhea. Treatment: performing symptomatic therapy. The form of release and packing On 5 ml of drug spill in an ampoule from dark glass. On 5 ampoules place in blister strip packaging from a film polyvinylchloride (PVC). On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a box of cardboard. To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C. To store out of children's reach! Not to freeze! Period of storage 4 years. Not to apply after an expiration date. Prescription status According to the prescription the Producer Mefar Ilach Sang. A.Sh Adres: Istanbul. Ramazanolu Makh. Ensar Dzhad. No. 20. Kurtkyoy-Pendik, Turkey Owner of the registration certificate Uorld Meditsin Ilach Sang. ve Tidzh. A.Sh. Adres: Evren Move., Dzhami Yolu Dzhad. No. 50, Gyuneshli, Bagdzhylar, 34192 Istanbul, Turkey the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality produktsiirk, Almaty, Turksibsky district, Suyunbaya Ave., 222 btel / fax: 8 (7272) 529090www.worldmedicine.kzadres the organization responsible for post-registration observation of safety of medicine, TROKA-S PHARMA LLP, Almaty, Suyunbaya Ave., 222bsotovy ph. +7 701 786 33 98 (24-hour access).
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