Active substanceAmino acids for parenteral nutritionAmino acids for parenteral nutrition
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  • Dosage form: & nbspsolution for infusions
    Composition:

    1 liter of solution contains:

    6%

    10%

    L-isoleucine

    4,800 grams

    8,000g

    L-leucine

    7,800 grams

    13,000g

    L-lysine monoacetate

    7,200 g

    12,000 grams

    (resp. L-lysine

    5,110 g

    8.51 g)

    L-methionine

    1.872 grams

    3.120 g

    L-phenylalanine

    2.250 g

    3.750 g

    L-treonine

    2.640 g

    4,400 g

    L-tryptophan

    1.260 g

    2.010 g

    L-valin

    5,400 grams

    9,000 grams

    L-arginine

    4,500 g

    7,500 grams

    L-cystidine

    2.856 g

    4.760 g

    Glycine

    2.490 g

    4.150 g

    L-alanine

    5.580 grams

    9,300 g

    L-proline

    5.866 grams

    9.710 g

    L-serine

    4.602 g

    7.670 g

    Taurine

    0.240 g

    0.400 g

    N-acetyl- L-cysteine

    0.420 g

    0.700 g

    (resp. L -cysteine

    0.312 grams

    0.520 g)

    N-acetyl-T-tyrosine

    3.106 g

    5.176 g

    (resp. L-tyrosine

    2.520 grams

    4,200 g)

    L-Apple acid

    1.572 g

    2,620 grams

    Water for injections

    up to 1 liter

    up to 1 liter

    Total amino acid content

    60 grams

    100 g

    Total nitrogen content

    9 grams

    14.9 g

    Titrated acidity

    27-40 mmol NaOH/ l,

    pH

    5,5-6,0

    Theoretical osmolality

    531 mOsm / l

    885 mOsm / l

    Description:

    Transparent or slightly opalescent,from a colorless to pale yellow solution.

    Pharmacotherapeutic group:The drug for parenteral nutrition (amino acid solution)
    ATX: & nbsp

    B.05.X.B   Amino acids

    Pharmacodynamics:
    1. Aminovene Infant 6%, 10% amino acids included in the preparation are physiological components. After parenteral administration, they are included in the pool of free amino acids of the organism and participate in all metabolic processes, in particular, they are used for the synthesis of proteins.
    Pharmacokinetics:

    Bioavailability of the drug Aminoven Infant 6%, 10% with intravenous administration is 100%. Amino acids are included in a common pool of free amino acids of the body and are distributed in the interstitial fluid and the intercellular space of organs and tissues. The concentration of free amino acids in the blood plasma and the cytoplasm of cells is regulated within narrow limits, depending on the age, nutritional status and general condition of the patient. With the correct administration (slowly and at a constant rate) Aminoven infanta 6%, 10% does not violate the balance of amino acids. With severe violations of the liver and kidneys, the balance of amino acids is not regulated.In these cases, special formulations of amino acid solutions for parenteral nutrition should be used. Only a small part of amino acids is eliminated by the kidneys. The half-life of amino acids from plasma is largely dependent on age.

    Indications:

    Aminoven Infant 6%, 10% is intended for partial parenteral nutrition of newborns, young children and premature babies. Together with solutions of carbohydrates, fat emulsions, as well as preparations of vitamins, electrolytes and microelements provides full parenteral nutrition.

    Contraindications:

    Like other solutions of amino acids Aminoven infant 6%, 10% should not be introduced for violations of amino acid metabolism, metabolic acidosis, hyperhydration, hypokalemia. With hepatic and renal failure, individual dosing is required.

    Dosing and Administration:

    Aminoven Infant 6% is intended for long-term intravenous drip injection into peripheral or central veins.

    Maximum injection rate: up to 0.1 g of amino acids per 1 kg of body weight, per hour = 1.67 ml / kg.

    The maximum daily dose:

    - children under 1 year - 1,5-2,5 g of amino acids per 1 kg of body weight, or from 25 ml to 40 ml of solution Aminoven Infanta 6% per 1 kg of body weight per day.

    - Children 2-5 years - 1.5 g of amino acids per 1 kg of body weight, or 25 ml per 1 kg of body weight per day.

    Aminoven Infant 10% is intended for long-term intravenous drip, mainly in the central veins.

    Maximum injection rate: up to 0.1 g of amino acids per 1 kg of body weight per hour, which is 1 ml per kg of body weight per hour.

    The maximum daily dose:

    - children up to 1 year - 1.5-2.5 g of amino acids per 1 kg of body weight per day, or 15 - 25 ml of Aminovene Infanta 10% per 1 kg of body weight per day.

    - children aged 2-5 years - 1.5 grams of amino acids per 1 kg of body weight per day, or 15 ml per 1 kg of body weight per day.

    - Children aged 6-14 years - 1.0 g of amino acids per 1 kg of body weight per day, which is 10 ml per 1 kg of body weight per day.

    Aminoven infanta 6%, 10% is applied as long as there is a need for parenteral nutrition.

    Side effects:

    If used correctly, it is not found. With the infusion of the drug Aminoven Infant 6%, 10% in the peripheral veins, there may be signs of a local reaction: redness, phlebitis, thrombosis. Daily monitoring of the puncture area is recommended.

    Overdose:

    When the dosage or the rate of administration of the drug is exceeded Aminoven infant 6%, 10%, as with overdose of other amino acid solutions, there is chills, nausea, vomiting, renal amino acidosis. There may also be acute circulatory disorders. In this case, the drug should be discontinued immediately. When hyperkalaemia occurs, inject from 200 to 500 ml of a 5% glucose solution with the addition of 1- 3 ME insulin for every 3-5 g of glucose.

    Interaction:

    Amino acid solutions because of the increased risk of microbial contamination should not be confused with other drugs.

    You should avoid adding other drugs to the drug Aminoven Infant 6%, 10%, as this can cause toxic reactions. In any case, you need to be sure of the compatibility of the preparations, the preservation of sterility and thorough mixing. Solutions with the addition of other medicines are not subject to storage.

    Special instructions:

    When parenteral nutrition of young children should take into account the following indicators: urine nitrogen, ammonia, glucose, electrolytes, triglycerides (with additional administration of fat emulsions), liver enzymes, serum osmolality, acid-base balance and water-salt metabolism.

    Too fast infusion can lead to loss of amino acids through the kidneys, and as a result, to an imbalance of amino acids.

    Form release / dosage:

    Solution for infusion.

    Packaging:100 ml or 250 ml in a glass vial made of hydrolytic class II glass, corked with rubber (halobutyl) stopper and coated with an aluminum cap with a plastic cap - the control of the first autopsy (Hearth.F.).

    For 10 bottles with plastic holders or without them in a carton box along with instructions for use.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze. Open vial with Aminoven Infant 6%, 10% should be stored in the refrigerator for no more than 24 hours. Keep out of the reach of children.

    Shelf life:

    24 months.

    Use immediately after opening the vial. Do not use Aminoven Infant after the expiration date. Use if the solution is transparent and the package is not damaged.

    Terms of leave from pharmacies:For hospitals
    Registration number:П N013844 / 01
    Date of registration:19.03.2007
    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: & nbsp07.08.2017
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