Aminosteril® H-Gepa (Aminosteril® N-Hepa)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for infusions
Composition:

1 liter of solution contains:

Active substances:

L-isoleucine

10.40 g

L-leucine

13.09 g

Llysine monoacetate

9.71 g

which corresponds L-lizinu

6.88 g

L-methionine

1.10 g

N-acetyl-L-cysteine

0.70 g

L-cysteine

0.52 g

L-phenylalanine

0.88 g

L-treonine

4.40 g

L-tryptophan

0.70 g

L-valina

10.08 g

L-arginine

10.72 g

L-histidine

2.80 g

Glycine

5.82 g

L-alanine

4.64 g

L-prolin

5.73 g

L-serine

2.24 g

Acid glacial acetic acid

4.42 g

Excipients:

Water for injections

up to 1 liter

Total nitrogen content

12.9 g / l

Total concentration of amino acids

80 g / l

Energy value

1340 kJ / l (= 320 kcal / l)

pH

5,7-6,3

Titrated acidity by NaOH

12-25 mmol / l

Theoretical osmolality

770 mosm / l
Description:

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

Pharmacotherapeutic group:Parenteral nutrition - amino acids
ATX: & nbsp
  • Amino acids
    • Pharmacodynamics:

    Aminosteryl H-Gepa - a solution of amino acids (interchangeable and irreplaceable) necessary for protein synthesis in the body and achieving a positive nitrogen balance with prolonged parenteral nutrition and in the postoperative period. A specially adapted solution for patients with impaired liver function, containing a high number of branched-chain amino acids and arginine, and a low-amino acid with a straight chain.

    Indications:

    - For parenteral nutrition of patients with hepatic insufficiency with or without encephalopathy;

    - therapy of severe violations of the liver (hepatic coma).

    Contraindications:

    Severe violations of the metabolism of amino acids extrahepatic etiology, hyperhydration state, hyponatremia, hypokalemia, severe heart failure.

    Pregnancy and lactation:

    Special controlled clinical trials on the use of the drug in this category of patients were not conducted. The use is permissible after assessing the risk-benefit relationship for the mother and fetus; Do not exceed the recommended dosage.

    Dosing and Administration:

    Intravenously.

    The drug Aminosteryl H-Gepa can be injected into the central or peripheral vein.

    Usually prescribed at a rate of 1.0-1.25 ml / kg of weight per hour, which is 0.08-0.1 g of amino acids per kg of body weight of the patient per hour. The maximum infusion rate is 1.25 ml / kg of body weight per hour, which is 0.1 g of amino acids per kilogram of body weight of the patient per hour.

    The maximum daily dose of 18.75 ml per kg per day, which is 1.5 grams of amino acids per kg of body weight per day. This is equal to 1300 ml per day with a patient weight of 70 kg.

    Aminosteryl H-Gepa can be used for as long as required by the clinical condition of the patient or before the normalization of amino acid metabolism.

    Special studies to study the safety of the drug in children have not been conducted. Do not use Aminosteril H-Gepa in children.

    Side effects:

    Possible hypersensitivity reactions.

    If the speed of administration is exceeded, nausea, vomiting, redness of the skin, sweating may be noted.

    Overdose:

    Exceeding the recommended rate of infusion into the peripheral vein can cause thrombophlebitis.

    Depending on the degree of the already existing disorder, the liver may worsen, chills, vomiting, nausea, an increase in the excretion of amino acids through the kidneys.

    In case of signs of overdose, it is necessary to reduce the rate of drug administration or stop the infusion.

    Interaction:

    Due to the increased risk of microbiological contamination and incompatibility, amino acid solutions should not be mixed with other drugs not intended for parenteral nutrition.

    Special instructions:

    Aminosteril H-Gep is recommended to be used as part of parenteral nutrition in combination with a sufficient number of energy sources (glucose solutions, fat emulsions), solutions of electrolytes, vitamins and trace elements. Preparation of mixtures should be carried out with strict adherence to aseptic conditions and compatibility.

    The balance of electrolytes and carbohydrates should be maintained, and their parallel infusion is possible.

    The concentration of serum electrolytes, fluid balance, acid-base status and kidney function should be monitored.

    The choice of the location of the catheter (central or peripheral vein) is determined by the final osmolarity of the mixture - for infusion into the peripheral vein the osmolarity limit is about 800 mosmol / l. In addition, the age, clinical condition of the patient and the condition of his peripheral veins should be taken into account.

    Any infusion into the peripheral vein can cause irritation of the vessel wall and thrombophlebitis, therefore it is recommended that the catheter site be constantly monitored.

    Use immediately after opening the vial.

    Only for single dosing.

    Use only a transparent solution that does not contain any mechanical inclusions from intact packaging.

    The unused remainder of the solution in the vial and the mixture remaining after the infusion should be destroyed.

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

    It was not reported on the effect of the drug on the ability to drive and work with machinery.

    Form release / dosage:

    Solution for infusion.

    Packaging:

    500 ml in a bottle of colorless hydrolytic glass, sealed with a rubber (halobutyl) stopper and rolled in with an aluminum cap with a plastic cap-control the first dissection.

    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 FROM. Do not freeze.

    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:For hospitals
    Registration number:П N012941 / 01
    Date of registration:08.11.2011
    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: & nbsp09.08.2017
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