Aminoplasmal Gepa (Aminoplasmal Hepa)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAmino acids for parenteral nutritionAmino acids for parenteral nutrition
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    • Dosage form: & nbspsolution for infusions
    Composition:

    1000 ml of solution contains:

    Active substances:

    Isoleucine 8,800g

    Leucine 13,600g

    Lysine monoacetate 10,600g

    (corresponds to lysine) 7,150g

    Methionine 1200g

    Phenylalanine 1600g

    Threonine 4600g

    Tryptophan 1500g

    Valine 10,600g

    Argignin 8,800g

    Histidine 4,700g

    Alanine 8,300g

    Glycine 6,300g

    Asparagine monohydrate 0.550 g

    (corresponding to asparagine) 0.480

    Aspartic acid 2,500g

    Glutamic acid 5,700g

    Ornithine hydrochloride 1.660g

    (corresponding to ornithine) 1,300g

    Proline 7,100 g

    Serin 3,700g

    Acetyltyrosine 0,860g

    (corresponds to tyrosine) 0.700g

    Acetylcysteine ​​0,800g

    (corresponding to cysteine) 0.590g

    Excipients:

    Sodium hydroxide 0 to 2.0 mmol

    or

    Hydrochloric acid 0 to 2.0 mmol

    Disodium edetate dihydrate 0.050 g

    Water for injection up to 1000ml

    Concentration of electrolytes:

    Chlorides 10 mmol / l

    Acetates 51 mmol / l

    Physico-chemical characteristics:

    Theoretical osmolality 875 mOsm / l

    pH from 5.5 to 6.5

    Amino acid content 100 g / l

    Total nitrogen 15.3 g / l

    Energy value 1675 kJ / l (400 kcal / l)

    Description:

    A clear, colorless or pale yellow solution.

    Pharmacotherapeutic group:Parenteral nutrition - amino acids
    ATX: & nbsp

    B.05.X.B   Amino acids

    Pharmacodynamics:

    Aminoplasmal Hepa contains 20 amino acids in the form of levorotatory isomers. The composition of this solution is characterized by a relatively high content of branched amino acids with respect to aromatic amino acids and is adapted to the metabolism of amino acids and proteins in patients with hepatic insufficiency.

    In acute and chronic hepatic insufficiency, there is an imbalance of amino acids in the plasma, characterized by a reduced level of branched amino acids - valine, leucine, isoleucine, and an elevated level of aromatic amino acids - phenylalanine and tyrosine. Reduced levels of branched amino acids in plasma are associated with increased catabolism of these amino acids in muscles.

    The increase in the concentration of aromatic amino acids, the oxidizing enzymes of which are localized only in the liver, is associated with a decreased hepatic metabolism due to hepatic insufficiency. In addition, in acute and chronic hepatic insufficiency, the disintegration of proteins in the muscles is increased, which leads to an additional release of aromatic amino acids into the plasma.

    The purpose of the drug Aminoplasmal Gep is aimed at reducing the catabolic utilization of amino acids and maintaining the amino acid homeostasis in plasma.

    The introduction of all the amino acids necessary for the synthesis of proteins (including conditionally replaceable and non-replaceable amino acids) included in the drug Aminoplasmal Gepa, provides high nutrient efficiency and reduces the burden on the body during protein synthesis.

    Thus, the main therapeutic effect of the drug Aminoplasmal Gep is to supply the body with a substrate for the synthesis of proteins in parenteral nutrition of patients with hepatic insufficiency. In this case, cerebral manifestations of the disease, i.e. hepatic encephalopathy, hepatic precoma or coma, weaken, and protein tolerance and biosynthesis are significantly improved.

    When infusion of the drug Aminoplasmal Gep, the following results are achieved: the level of amino acids with branched chain is normalized; the level of aromatic amino acids is normalized; the Fisher coefficient is normalized; the severity of symptoms of hepatic encephalopathy decreases; the concentration of ammonia in the blood decreases.
    Pharmacokinetics:

    Amino acids formed from exogenous proteins and amino acids in the solutions administered parenterally are subjected to the same biochemical processes.

    Intravenous amino acids enter the intravascular and intracellular depots of endogenous free amino acids. Amino groups formed as a result of deamination of branched amino acids bind to glutamate to form glutamine, which is transported by the bloodstream to the intestine and muscles for further utilization. Bioavailability of intravenously administered amino acids is 100%.

    Indications:

    For parenteral nutrition in violation of the amino acid balance arising in acute and chronic liver diseases, as well as for the prevention and treatment of hepatic encephalopathy.

    Contraindications:

    - Disorders of the amino acid metabolism of extrahepatic etiologies;

    - Severe circulatory disorders (shock);

    - Pulmonary edema;

    - Pronounced acidosis;

    - Hyperhydration;

    - Pronounced hypokalemia;

    - Pronounced hyponatremia;

    - Hypersensitivity to the components of the drug;

    - Children under 2 years;

    - Pregnancy;

    - Lactation period.

    In connection with the peculiarity of amino acid composition, Aminoplasmal Gepa should be used only in accordance with the above indications. When using the drug Aminoplasmal Gepa in other cases, there may be violations of the amino acid exchange.

    Carefully:

    Use with caution in patients with increased plasma osmolality.

    Dosing and Administration:

    Aminoplasmal Hepa is administered intravenously, through a central venous catheter.

    The method of application of the preparation:

    The drug is supplied in bottles designed for single use. Any unused volumes of the drug are not subject to storage and must be discarded. Do not use the drug if the solution is not clear, there are obvious signs of damage on the bottle or leakage is broken.

    Recommended doses

    If the doctor is not prescribed otherwise, then, taking into account the individual needs of the patient, the following doses are recommended:

    Adults:

    Standard dose:

    7-10 ml / kg of body weight / day, which corresponds to 0.7-1 g of amino acids / kg of body weight / day.

    Maximum dose:

    15 ml / kg of body weight / day, which corresponds to 1.5 g of amino acids / kg of body weight / day.

    Children from 2 years:

    Standard dose:

    7-10 ml / kg of body weight / day, which corresponds to 0.7-1 g of amino acids / kg of body weight / day.

    When using the drug Aminoplasmal Gepa in children, it is necessary to carefully take into account age, nutritional status and the underlying disease of the patient.

    In the case of complete parenteral nutrition, it is also necessary to introduce carbohydrates, essential fatty acids, vitamins and microelements.

    Infusion rate:

    Treatment of hepatic coma

    For patients with hepatic encephalopathy, it is recommended at the beginning of treatment to administer Aminoplasmal Gepa at a high rate, until an effect occurs. For example, for a patient weighing 70 kg: during the first two hours of infusion:

    50 drops / minute, which corresponds approximately to 150 ml / hour (2 ml / kg body weight / hour)
    from the 3rd to the 4th hour of infusion:
    25 drops / min, which corresponds approximately to 75 ml / hour (1 ml / kg body weight / hour)
    starting from the 5th hour of infusion:
    15 drops / minute, which corresponds approximately to 45 ml / hour (0.6 ml / kg body weight / hour).

    Supportive therapy / parenteral nutrition:

    15-25 drops / min, which corresponds approximately to 45-75 ml / h (0.6-1.0 ml / kg body weight / hour).

    Duration of use:

    Aminoplasmal Hep should be used until the threat of development of hepatic encephalopathy disappears.

    Side effects:

    If you follow the recommendations for these precautions, the speed of administration and dosage, no side effects are observed, but the development of allergic reactions is possible.

    Overdose:

    Overdose or excess of the recommended infusion rate of the drug may cause such things as chills, nausea, vomiting and increased excretion of amino acids by the kidneys. In such cases, the administration of the drug should be discontinued and resumed later with a lower infusion rate.

    Interaction:

    Drug interactions with other drugs are not known.

    Due to the danger of bacterial contamination and physico-chemical incompatibility, it is not recommended to introduce anyother preparations in Aminoplasmal Gepa, preferably include them in standard solutions of carbohydrates or electrolytes. However, it is possible to mix the preparation

    Aminoplasmal Hepa with other solutions for parenteral nutrition after checking their compatibility.

    Special instructions:

    Do not administer into peripheral veins.

    If a patient has renal failure at the same time, the dose of amino acids should be adjusted depending on the level of urea and creatinine in the serum.

    Therapy with amino acid solutions does not replace other therapeutic measures established for the treatment of hepatic encephalopathy.

    Simultaneously with the introduction of the amino acid composition, the use of other nutrients is indicated. The introduction of the drug Aminoplasmal Gep should be accompanied by the introduction of an adequate amount of carbohydrates. Electrolytes should be used according to the needs.

    During the treatment period, it is necessary to control the electrolyte insertion-electrolyte balance, plasma osmolality, acid-base balance, glucose concentration in the blood and liver function. The frequency and method of control depends on the severity of the disease and the severity of the patient's condition.Duration of introduction from one bottle should not exceed 24 hours.

    Form release / dosage:

    Solution for infusions 10%.

    Packaging:

    By 500 ml in bottles of class II hydrolytic glass, the requirements of the European Pharmacopoeia for infusion solutions. Bottle is sealed with a rubber stopper of brick color, corresponding to the requirements of the European Pharmacopoeia for infusion solutions, an aluminum cap of brick-red color and plastic plug of gray color. For 1 bottle of 500 ml together with instructions for use in a cardboard pack.

    For hospitals.

    For 10 bottles of 500 ml, along with instructions for use in a cardboard box.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C in a dark place. Do not freeze! Keep out of the reach of children.

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:P N 015440/01
    Date of registration:05.11.2008 / 07.07.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp08.08.2017
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