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Ketosteril 100s film-coated tablets




The instruction for medical use of Ketosteril Torgovoye medicine a name Ketosteril Mezhdunarodnoye the unlicensed name Is not present the Dosage form of the Tablet, film coated Structure 1 tablet contains active agents: an isoleucine an alpha ketoanalogue (DL-methyls-oxo-2-calcium valerinat) 67 mg, a leucine an alpha ketoanalogue (methyl-4-oxo-2-calcium valerinat) 101 mg, phenylalanine an alpha ketoanalogue (oxo-2-phenyl-3-calcium propionate) 68 mg, valine an alpha ketoanalogue (methyl-oxo-2-calcium butyrate) 86 mg, methionine an alpha hydroxyanalogue (DL-hydroxy-2-calcium methyl butyrate) of 59 mg, a L-lysine acetate (in terms of a L-lysine) 105 mg (75 mg), L-threonine of 53 mg, L-tryptophane of 23 mg, a L-histidine of 38 mg, L-tyrosine of 30 mg, excipients: corn starch, krospovidon, talc, silicon dioxide colloidal anhydrous, magnesium stearate, macrogoal 6000, povidone, film cover: talc, a macrogoal 6000, quinolinic yellow (E104), methacrylate copolymer the bottled main (eudragit E 12.5), triacetin, the titan dioxide (E171). The general content of calcium in a tablet of 50 mg the Description Oblong, biconvex tablets, film coated yellow color with silky gloss. Pharmacotherapeutic group of Amino acid, including a complex with polypeptides. The ATX V06DD code the Pharmacological Pharmacokinetics Plasma Kinetics properties of amino acids and their embedding in metabolic ways are well studied. Nevertheless, it should be noted that processes of absorption at the uraemic patients accepting amino acids do not lead to disturbance of their plasma concentration, that is absorption is not broken. Changes of plasma concentration arise after absorption of amino acids which can be revealed at an early stage of a disease. Plasma concentration of ketonic acids at healthy people increase within 10 min. after intake. Individual concentration of ketonic acids increase to five times from initial. The maximum plasma concentration are reached within 20-60 min. and after 90 min. their levels return to initial. Therefore absorption from digestive tract very fast. Simultaneous increase in plasma concentration of ketonic acids and corresponding amino acids testifies to the high speed of transamination. In view of existence in an organism of physiological ways of utilization of ketonic acids, exogenous ketonic acids, are quickly distributed in recyclings. Ketonic acids pass the same ways of catabolism, as usual amino acids. Separate researches of removal of ketonic acids were not conducted. A pharmacodynamics the Combined drug. Provides supply with important irreplaceable amino acids at the minimum administration of nitrogen. After administration of drug inside, keto- and hydroxy – analogs of amino acids in an organism transaminirutsya enzymatically in the corresponding L-amino acids, receiving nitrogen from replaceable amino acids, thereby reducing ureapoiesis by reuse of an amino group. Drug promotes utilization of nitrogen-containing products of exchange, anabolism of proteins at simultaneous decrease in concentration of urea. Improves nitrogen metabolism. Reduces concentration in blood of potassium ions, magnesium and phosphorus. Keto- and hydroxyacids do not cause hyper filtration in the remained nephrons. the Keto-containing additives positively influence a renal hyperphosphatemia and a secondary hyperparathyreosis. Moreover, improvement of a course of an osteodystrophy is possible. Use of drug together with very low protein diet allows to reduce consumption of nitrogen for prevention of harmful consequences of malnutrition and disturbance. Indications – protein-energy malnutrition, prevention and treatment of the disturbances caused by the changed proteinaceous metabolism in chronic kidney disease and at restriction of protein in a diet. Lower than 25 ml/min. are generally applied at patients with chronic kidney disease with glomerular filtration rate that does not exclude use at glomerular filtration rate and higher than 25 ml/min. Route of administration and doses For intake. The adult, if it is not appointed differently, (at the body weight of 70 kg) 4-8 tablets 3 times a day during meal. Swallow, without chewing. Ketosteril appoint during the entire period when glomerular filtration rate is lower than 25 ml/min., along with reception it is recommended to limit contents in protein food to 40 g/day or less depending on degree of chronic kidney disease. Side effects Often – Rash, eczema, an erythema, dermatitis (including contact dermatitis), naggers Redko – dermatitis violent It is very rare – asthma, hypersensitivity (including a small tortoiseshell), a Quincke’s disease – pustulous rash – reactions of photosensitivity In some cases can develop a hypercalcemia. At the same time it is recommended to reduce intake of vitamin D. If the hypercalcemia remains, to reduce Ketosteril’s dose and also other sources of calcium. Contraindications – hypersensitivity to drug components – a hypercalcemia – disturbances of exchange of amino acids – hereditary phenylketonuria – pregnancy and the period of a lactation – children’s and teenage age up to 18 years Medicinal interactions Co-administration of medicines, calciferous, can lead to increase in level of calcium in blood serum. In process of reduction of uraemic symptoms under the influence of Ketosteril, the dose of at the same time appointed aluminum hydroxide has to be respectively reduced. It is necessary to monitor decrease in level of phosphates in blood serum. Not to break absorption in intestines, it is not necessary to take together with Ketosteril the medicine capable to form difficult soluble compounds with calcium (for example, the tetracyclines, hinolona, drugs containing iron, fluorine and estramustinum). Between Ketosteril’s reception and similar drugs there has to be an interval not less than 2 hours. Special instructions Ketosteril should be accepted at meal time for its best absorption and transformation into the corresponding amino acids. It is regularly necessary to watch calcium level in blood serum. It is required to provide the sufficient caloric content of food. Emergence of allergic reactions at patients with hypersensitivity to drug components is in some cases possible. Pregnancy and a lactation are Not enough experience of use at pregnancy and a lactation. Features of influence of medicine on ability to run transport and other potentially dangerous mechanisms the Overdose of Cases on overdose does not influence it is not revealed. The form of release and packing On 20 tablets place in blister strip packaging from aluminum/PVC. On 5 planimetric packs place in the soldered package from aluminum/PVC. On 1 package together with the instruction for medical use in the state and Russian languages place in a pack from 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! 3 years not to use a period of storage after an expiration date! Prescription status According to the prescription the Producer Labesfal Laboratorios Almiro, S.A. The zone industrial to Lagedo, 3465-157, Santiago de Besteyros, Portugal the Owner of the registration certificate of Frezenius Kabi Doychland GmbH, Bud Homburg, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan a claim (offer) on quality of medicines from consumers of MPA Medical Partners LLP, 050000, Almaty, Rozybakiyev St., a corner of Timiryazev St., 125-6/76, quarter 33. Ph./fax: +7 (727) 380 01 10. E-mail: Address of the organization responsible for post-registration observation of safety of medicine of SP Musrepbekova G. Zh., 050050 Almaty, Makarenko St., 66-42. Ph./fax: +7 (727) 384 38 05, mob.: +7 (775) 715 94 75. E-mail:


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