Ketosteril® (Ketosteril®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceKetoanalogues of amino acidsKetoanalogues of amino acids
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    ALVILS, LTD.     Russia
  • Ketosteril®
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    Fresenius Kabi Deutschland GmbH     Germany
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet contains:

    active ingredients: isoleucine alpha-keto analogue (DLmethyl-oxo-2-calcium valerinate) 67 mg,

    leucine alpha-keto analogue (methyl 4-oxo-2-calcium valerinate) 101 mg,

    phenylalanine alpha-keto analogue (oxo-2-phenyl-3-calcium propionate) 68 mg,

    valine alpha-keto analogue (methyl-oxo-2-calcium butyrate) 86 mg,

    methionine alpha-hydroxy analogue (DL-hydroxy-2-calcium methylbutyrate) 59 mg,

    Llysine monoacetate 105 mg,

    L-treonine 53 mg,

    L-tryptophan 23 mg,

    L-gistidium 38 mg,

    L-tyrosine 30 mg;

    other ingredients: corn starch 44 mg, povidone 6.0 mg, talc 19.57 mg, silicon colloidal dioxide 4.4 mg, magnesium stearate 15.0 mg, macrogol 6000 12.8 mg, povidone soluble 43.2 mg;

    tablet shellTalc 9.1 mg Macrogol 6000 1.48 mg, quinoline yellow (E104) 0.72 mg of methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate copolymer (Eudragit E 12.5) 5.9 mg, 0.43 mg of triacetin, titanium dioxide 7.4 mg.

    The total nitrogen content in the tablet is 36 mg.

    The calcium content in the tablet is 1.25 mmol = 50 mg.

    Description:

    Oblong, biconvex tablets, coated with a yellow coating.

    Pharmacotherapeutic group:Renal failure treatment
    ATX: & nbsp

    V.06.D.D.   Amino acids, including combinations with polypeptides

    Pharmacodynamics:

    Combined drug. Provides a complete supply of essential amino acids with a minimum of nitrogen. The ketone analogs of amino acids in the body are enzymatically transaminated into the corresponding L-amino acid, while cleaving the urea. The drug promotes the utilization of nitrogen-containing metabolic products, the anabolism of proteins while reducing the concentration of urea in the serum. Improves nitrogen metabolism. Reduces the concentration in the blood of ions of potassium, magnesium and phosphate. With the systematic use of the drug, improvement in the condition of patients with chronic renal insufficiency was noted. In some cases, it is possible to delay the onset of dialysis.

    Indications:

    Protein-energy deficiency, prevention and treatment of disorders in adults and children from 3 years, caused by altered protein metabolism in chronic renal failure and with protein restriction in the diet. It is mainly used in patients with chronic renal failure with a glomerular filtration rate below 25 ml / min, which does not exclude the use at a glomerular filtration rate and above 25 ml / min.

    Contraindications:

    Hypercalcemia, impaired metabolism of amino acids, hypersensitivity.

    With hereditary phenylketonuria, it should be borne in mind that the drug contains phenylalanine.

    Dosing and Administration:

    For ingestion.

    Adults and children from 3 years of 1 tablet per 5 kg of body weight per day or 0.1 g / kg of body weight per day. If not prescribed otherwise, take 3 times daily with meals. Swallowed without chewing.

    Duration of use. Ketosteril® is administered during the entire period when the glomerular filtration rate is below 25 ml / min. In the pre-dialysis period, protein content of protein is recommended to not exceed 40 grams of protein per day, depending on the degree of chronic renal failure. In patients on dialysis, protein intake should be in accordance with accepted standards.

    Usual Adult Dose (body weight 70 kg) is 4-8 tablets 3 times a day.

    Usual dose for children - 1 tablet per 5 kg of body weight per day.

    Recommended protein content in food for children from 3 to 10 years is 1.4-0.8 g / kg body weight per day, for children from 10 years - 1.0-0.6 g / kg body weight per day.

    Side effects:

    In some cases, hypercalcemia may develop.It is recommended to reduce the intake of vitamin D. If hypercalcemia persists, reduce the dose of Ketosteril®, as well as other sources of calcium.

    Interaction:

    Simultaneous administration of drugs containing calcium, can lead to an increase in the level of calcium in the serum. As the uremic symptoms decrease under the influence of Ketosteril®, the dose of simultaneously prescribed aluminum hydroxide should be reduced accordingly. It should monitor the decrease in serum phosphate levels. In order not to violate absorption in the intestine, it is not necessary to take with Ketosteril® medicaments that are able to form difficult-to-dissolve compounds with calcium (for example, tetracyclines, quinolones, preparations containing iron, fluorine and estramustine). Between the intake of Ketosteril® and similar preparations should be an interval of at least 2 hours.

    Special instructions:

    There is not enough experience in pregnancy and lactation.

    Ketosteril® should be taken with food to be better absorbed and converted to the appropriate amino acids.

    It is necessary to regularly monitor the level of calcium in the blood serum. It is required to provide sufficient caloric content of food.

    In some cases, the occurrence of allergic reactions in patients with hypersensitivity to the components of the drug.

    Form release / dosage:

    Film-coated tablets.

    Packaging:

    20 tablets per blister Al / PVC. 5 blisters per sealed package of Al/ PVC.

    1 packet in a pack of cardboard with instructions for use.

    Storage conditions:

    In dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N011683 / 01
    Date of registration:25.12.2008 / 03.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspFRESENIUS KABI DEYCHLAND GmbH FRESENIUS KABI DEYCHLAND GmbH Germany
    Information update date: & nbsp07.01.2018
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