Active substanceAmino acids for parenteral nutritionAmino acids for parenteral nutrition
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  • Dosage form: & nbspconcentrate for solution for infusion
    Composition:

    1 liter of the drug contains:

    Active substance:

    N (2)-L-alanyl-L-glutamine 200.0 g, which corresponds approximately to L-alanine 82.0 g, L-glutamine 134.6 g,

    excipient: water for injection up to 1.0 liter.

    Theoretical osmolarity: 921 mOsm / l

    Titrated acidity: 90-105 mmol NaOH / l

    pH: 5.4-6.0

    Description:

    Clear solution.

    Pharmacotherapeutic group:The nutrition of the parenteral remedy is amino acids.
    ATX: & nbsp

    B.05.X.B   Amino acids

    Pharmacodynamics:

    The dipeptide M (2) -L-alanyl-L-glutamine replenishes glutamine deficiency under stress or critical condition in patients receiving complete or partial parenteral nutrition. Introduction Dipeptiven regulates nitrogen balance and protein metabolism, supports intracellular glutamine pool, corrects catabolic reaction,improves immune function, reduces the incidence of infectious complications, restores bowel function. Glutamine in the composition of Dipeptiven restores the intestinal barrier, reduces the translocation of bacteria, strengthens the immune function of the intestine, reduces the risk of sepsis and organ failure, prepares the intestine for further nutritional support.

    Pharmacokinetics:

    N(2)-L-alanyl-L-glutamine after intravenous administration is rapidly hydrolyzed in blood plasma with the formation of alanine and glutamine. Half-life N(2)-L-alanyl-L- glutamine is 2.4 - 3.8 minutes (4.2 minutes at the terminal stage of renal failure), its plasma clearance is 1.6-2.7 minutes. Infusion of the dipeptide N(2)-L-alanyl-L-glutamine leads to a rapid increase in the concentration of glutamine and alanine, during the entire infusion period only trace amounts of the dipeptide can be detected in plasma. Renal elimination N(2)-L-alanyl-L-glutamine with constant infusion does not exceed 5% and is identical with renal elimination of other amino acids.

    Indications:

    Dipeptiven is used in adults and children in the framework of complete or mixed parenteral nutrition for glutamine reimbursementincreased its consumption: hypermetabolic or hypercatabolic states of metabolism (against the background of multiple injuries, burns, severe surgical interventions, sepsis, severe inflammatory processes, immunodeficiency, malignant neoplasms).

    Contraindications:

    Severe renal failure (creatinine clearance less than 25 ml / min), severe hepatic insufficiency, severe metabolic acidosis, and intolerance to one of the components of the drug.

    Pregnancy and lactation:

    There are no data on the use of the drug in pregnant and lactating mothers. - The drug can be prescribed to pregnant women only if the benefit to the mother exceeds the potential harm to the fetus. When using the drug in nursing mothers, breast-feeding should be discontinued.

    Dosing and Administration:

    Intravenously, drip.

    Dipeptiven is a concentrated solution not intended for direct administration. Before infusion, it must be mixed with a compatible carrier solution (0.9% sodium chloride solution, 5 % or 10% dextrose solution, or containing amino acids 10 % infusion solution).One volume part of Dipeptiven should be mixed with about five volume parts of carrier solution (for example, 100 ml of dipeptivene mixed with 500 ml of a 10% solution of amino acids).

    In this case, the dose ratio of amino acids in 100 ml of Dipeptiven (20 g L-alanine-L- glutamine) and 500 ml carrier solution - 10 % solution of amino acids (50 g of amino acids) is 2: 5, which does not exceed the proportion of Dipeptivene in 30 % of the total number of amino acids introduced.

    The choice of the central or peripheral vein for administration depends on the terminal osmolarity of the mixture.

    Dipeptiven is intended for infusion into the central veins after addition to a compatible infusion solution.

    Mixtures of solutions with osmolarity greater than 800 mOsmol / l should be introduced into the central veins.

    Dosing regimen for adults and children.

    The dose depends on the severity of the patient's hypercatabolic state and the need for amino acids.

    With parenteral nutrition, the maximum daily dose is 2 g of amino acids / kg of body weight. When calculating the need, the addition of alanine and glutamine should be considered when Dipeptiven is administered.

    The proportion of amino acids supplied by the administration of dipeptivene should not be approximately 30% of the total amount of amino acids introduced.

    Daily dose

    1,5 - 2,5 ml Dipeptivenen per kg body weight (equivalent to 0.3 - 0.5 g / kg N(2)-L-alanyl-L- glutamine). This corresponds to 100 -175 ml of Dipeptivenen per day for a patient weighing 70 kg.

    The maximum daily dose:

    2.5 ml / kg (equivalent to 0.5 g / kg N(2)-L-alanyl-L-glutamine). The maximum daily dose of 0.5 g / kg N(2)-L-alanyl-L-glutamine should be administered in combination with compatible amino acid solutions, providing approximately 1.0 g of amino acids / kg / day. As a result, the daily dose is approximately 1.5 g of amino acids / kg.

    The following indicators are recommended when adding amino acids to the carrier solution:

    - when the need for amino acids is 1.2 g / kg per day: 0.8 g / kg of amino acids with the addition of 0.4 g / kg N(2)-L-alanyl-L-glutamine;

    - when the need for amino acids is 1.5 g / kg per day: 1.0 g / kg of amino acids with the addition of 0.5 g / kg N(2)-L-alanyl-L-glutamine;

    - when the need for amino acids 2 g / kg per day: 1.5 g / kg of amino acids with the addition of 0.5 g / kg N(2)-L-alanyl-L-glutamine;

    The infusion rate is determined by the infusion rate of the carrier solution and should not exceed 0.1 g of amino acids / kg / h.

    Maximum concentration N(2)-L-alanyl-L-glutamine for therapeutic use is 3.5 %.

    Duration of application - no more than 3 weeks. However, the experience of using Dipeptiven for more than 9 days is limited.


    Indication, if necessary, of the characteristics of the action of the medicinal product at the first reception or at its cancellation

    No data available.

    Side effects:

    Undesirable effects with proper application are not known.

    Rarely, allergic reactions.

    Overdose:

    If the speed of infusion is exceeded, chills, nausea, and vomiting may occur.

    If there are side effects, the drug should be discontinued immediately.
    Interaction:

    When mixed with a carrier solution (0.9% sodium chloride, 5% or 10% dextrose solution, amino acid solution), it is necessary to strictly follow the aseptic rules, to make sure of the compatibility of solutions and ensure their complete mixing.

    Dipeptiven can be administered intravenously along with amino acid solutions for parenteral nutrition or injected into multi-compartment parenteral nutrition packages.

    Special instructions:

    When Dipeptiven is introduced in patients with compensated hepatic insufficiency, monitoring of liver function parameters is necessary.

    It is necessary to control the electrolyte composition and osmolarity of the plasma, the water balance, the acid-base state,and also dynamically determine the indicators of the function - the liver (activity of alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase and bilirubin concentration in plasma). In addition, it is necessary to monitor symptoms of hyperammonemia.

    The choice of the route of administration between the central and peripheral veins depends on the osmolarity of the prepared solution for infusion. The upper limit of osmolality of the solution for administration to the peripheral vein is usually 800 mOsmol / l, but it can be revised depending on the age, general condition of the patient, and also on the condition of the peripheral veins.

    Before use, the vial and solution should be carefully inspected. It is possible to use only transparent solutions without suspended particles in undamaged vials.

    The drug should be used immediately after opening the vial.

    The bottle is intended for single use only.

    Dipeptiven should not be stored after adding other components.



    Indication, if necessary, of special precautions for destruction of unused medicines

    The unused solution must be disposed of in accordance with the standard procedure for the disposal of medications taken in this hospital.
    Effect on the ability to drive transp. cf. and fur:

    Does not affect.

    Form release / dosage:

    Concentrate for solution for infusion 20%.

    Packaging:50 ml or 100 ml in glass bottles (hydrolytic glass II class, Hebrew Pharm) with or without risk of casting, closed with rubber (halobutyl) stoppers (Hebrew Pharm.), Coated with aluminum caps, with plastic covers to control the first autopsy. For 10 vials with or without holders, together with instructions for use in a cardboard box (for hospitals).
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:П N012542 / 01
    Date of registration:17.06.2010
    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: & nbsp21.12.2011
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