Active substanceOrnithineOrnithine
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    FARMAK, JSC     Ukraine
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  • Dosage form: & nbspconcentrate for solution for infusion
    Composition:On 1 ml:

    Active substance: L-ornithine LAspartate - 500.0 mg;

    Excipient: water for injection - up to 1 ml.

    Description:Pa clear solution from colorless to light yellow in color.
    Pharmacotherapeutic group:Hypoazotemic means
    ATX: & nbsp

    A.05.B.A.06   Ornithine oxoglurate

    Pharmacodynamics:

    Reduces the increased concentration of ammonia in the body, in particular, with liver diseases. The effect of the drug is associated with its participation in the ornithine cycle of urea formation Krebs (formation of urea from ammonia). Ornithine acts as a catalyst for the enzymes carbamoyl phosphate synthetase and ornithine carbamoyltransferase, and is also the main for the synthesis of urea. In addition, the drug activates the ornithine cycle of urea formation, which also contributes to a decrease in the level of ammonia.Promotes the production of insulin and growth hormone. Improves protein metabolism in diseases requiring parenteral nutrition.

    Pharmacokinetics:

    In vivo forms two active metabolites: aspartate and ornithine, having a short half-life of 0.3-0.4 hours, are excreted by the kidneys through a cycle of urea generation. A small part of the aspartate is excreted by the kidneys unchanged.

    Indications:

    - Acute and chronic liver diseases, accompanied by hyperammonemia;

    - PEncephalic encephalopathy, incl. as part of complex therapy disorders consciousness (precoma and coma);

    - as a corrective additive to preparations for parenteral nutrition patients with protein deficiency.

    Contraindications:

    - Hypersensitivity to L-ornithine Laspartate.

    - severe renal failure (serum creatinine> 3 mg / 1 dl).

    - the period of breastfeeding.

    - Children under 18 years.

    Pregnancy and lactation:

    During pregnancy, the use of Larnamine is possible only under the strict supervision of the doctor, taking into account the benefit / risk relationship for the mother and fetus.

    For the duration of treatment, stop breastfeeding.

    Dosing and Administration:

    Intravenously (intravenously) is drip. Ampoule contents are mixed with 500 ml infusion solution (0.9% sodium chloride solution, 5% dextrose (glucose) solution or Ringer's solution).

    Adults

    The average therapeutic dose of 20 g of ornithine per day.

    When hepatic encephalopathy (depending on the degree of severity of the condition) iv injected up to 40 g of ornithine per day.

    It is recommended to dissolve not more than 30 g of ornithine in 500 ml of an infusion solution. The maximum infusion rate is 5 g of ornithine per hour.

    The duration of therapy with the drug is determined in each case individually, based on the pathology and severity of the patient's condition.

    In severe violations of liver function, strict monitoring of the patient's condition and correction of the rate of drug administration are necessary to prevent the development of nausea and vomiting.

    Side effects:

    The incidence of adverse events is as follows, according to the classification of the World Health Organization:

    Often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10 000, <1/1 000); very rarely (<1/10 000), including individual messages; frequency is not set (can not be calculated from available data).

    From the gastrointestinal tract: very rarely - nausea, vomiting.

    From the immune system: very rarely - allergic reactions.

    Overdose:

    Symptoms: increased severity of dose-dependent side effects.

    Treatment: The drug should be discontinued and symptomatic treatment should be given.

    Interaction:

    Not found.

    Larnamine should not be mixed with other medications. For dilution, use only the solutions listed in the instructions.

    Special instructions:

    When administering high doses of Larnamine, it is necessary to control the concentration of urea in blood plasma and urine.

    In severe violations of the liver in accordance with the patient's condition, it is necessary to reduce the rate of infusion solution administration in order to prevent nausea or vomiting.

    Larnamine, a concentrate for a solution for infusions, should not be injected into the artery.

    Effect on the ability to drive transp. cf. and fur:

    Larnamine does not affect the ability to drive vehicles and potentially dangerous mechanisms.

    Form release / dosage:

    Concentrate for solution for infusion, 500 mg / ml.

    Packaging:

    10 ml per ampoule of dark glass with a ring of fracture or break point. On the ampoules paste labels from paper self-adhesive.

    For 5 or 10 ampoules, together with the instructions for use, they are put in a bundle with corrugated cardboard inserts.

    Or 5 ampoules are put in a blister of PVC film.

    For 1 or 2 blisters with ampoules, along with instructions for use, put in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003826
    Date of registration:07.09.2016
    Expiration Date:07.09.2021
    The owner of the registration certificate:FARMAK, JSC FARMAK, JSC Ukraine
    Manufacturer: & nbsp
    Representation: & nbspFARMAK PAOFARMAK PAO
    Information update date: & nbsp12.03.2018
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