Nephrothect (Nephrotect)

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:

    1 liter of solution contains:

    L-isoleucine 5.80 g

    L-leucine 12,80 g

    L-lysine monoacetate 16.925 g

    (= Llisine 12.0 g)

    L-methionine 2.00 g

    L-phenylalanine 3.50 g

    L-treonine 8.20 g

    L-tryptophan 3.00 g

    L-valine 8.70 g

    L-arginine 8,20 g

    L-cystidine 9,80 g

    L-alanine 6,20 g

    N-acetyl-L-cysteine ​​0.54 g

    (=Lcysteine ​​0.40 g)

    Glycine 5,305 g

    L-proline 3.00 g

    L-serine 7.60g

    L-tyrosine 0.60 g

    Glycil -L-tyrosine (anhydrous) 3.155 g

    Acetic Acidic Acid 2,50-4,0 g

    Acid, apple 2.01 g

    Water for injection up to 1 liter

    The total amino acid content is 100 g / l,

    Total nitrogen content 16.3 g / l Theoretical osmolarity 935 mOsm / l

    Description:

    Transparent or slightly opalescent, from a colorless to pale yellow solution pH 5.5 - 6.5

    Pharmacotherapeutic group:nutrition parenteral remedy
    ATX: & nbsp

    B.05.X.B   Amino acids

    Pharmacodynamics:

    Nephrotect is a solution of essential and non-essential amino acids necessary for protein synthesis in the body and achieving a positive nitrogen balance with parenteral nutrition and replenishing amino acid loss during dialysis. Designed specifically for patients with impaired renal function.

    Pharmacokinetics:

    Amino acids that enter intravenously when Nephrotect is prescribed are anabolically utilized and included in the body proteins when energy substrates are available.

    Bioavailability with intravenous injection 100%.

    The distribution of amino acids by intravenous administration is identical to that of the supply of amino acids from the gastrointestinal tract during the hydrolysis of food proteins.

    Glycyl-L-tyrosine, included in Nephrotect as an additional source L-tyrosine, hydrolyzed with the subsequent utilization of amino acids L-tyrosine and glycine immediately after intravenous administration, including in patients with renal insufficiency. The half-life is 3.44 minutes.

    When administered at the recommended rate, only a small part of the administered amino acids is lost in the urine.

    Indications:

    - Introduction of amino acids with full or partial parenteral nutrition of patients with impaired renal function, including parenteral nutrition in acute and chronic renal failure, including patients on hemo- or peritoneal dialysis.

    - Replenishment of amino acid losses in hemo- or peritoneal dialysis.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Congenital disorders of amino acid metabolism.

    Acute phase of shock.

    General contraindications for infusion therapy: acute pulmonary edema, hyperhydration, decompensated heart failure, decompensated hypotonic dehydration.

    Carefully:

    Use with caution in patients with hyponatremia, increased blood osmolarity.

    Pregnancy and lactation:

    The introduction of amino acids in parenteral nutrition in patients with impaired renal function can be vital. When necessary, solutions of amino acids can be prescribed to pregnant women, nursing mothers and children. Adverse and side effects have not been noted in the appointment of pregnant women, nursing mothers and children. Teratogenic effects are not revealed.

    Before the appointment of Nephrotextus, pregnant and breastfeeding mothers need to assess the risk / benefit ratio.

    Dosing and Administration:

    Intravenously.

    The dose should be selected according to the individual needs of the patient. Unless otherwise prescribed:

    in patients with acute and chronic renal failure who do not receive hemo- or peritoneal dialysis: 0.6-0.8 g of amino acids per kg of body weight per day = 6-8 ml / kg / day;

    in patients with acute and chronic renal insufficiency, hemo- or peritoneal dialysis: 0.8-1.2 g of amino acids per kg of body weight per day = 8-12 ml / kg / day; replenishment of amino acid losses in hemo- or peritoneal dialysis: 0.5-0.8 g of amino acids per kg of body weight per day = 5-8 ml / kg / day.

    The maximum recommended daily intake for adults and children: 0.8 - 1.2 g of amino acids per kg of body weight per day = 8-12 ml / kg / day. This corresponds to approximately 560-840 ml / day for patients with a body weight of 70 kg.

    Maximum recommended rate of administration for adults and children:

    - Parenteral nutrition: 0.1 g of amino acids per kg of body weight per hour = 1 ml / kg / h.

    Replenishment of amino acid losses in hemo- or peritoneal dialysis: 0.2 g of amino acids per kg of body weight per hour = 2.0 ml / kg / h.

    Usually, when parenteral nutrition is carried out, any amino acid solutions are administered in combination with energy sources: glucose solutions and / or fatty emulsions. When carrying out full parenteral nutrition, Nephrotect is used together with energy sources, electrolytes, water-soluble and fat soluble vitamins and microelements. Nephrothet in combination with other preparations for parenteral nutrition can be injected into the central or peripheral veins, depending on the final osmolarity.

    Nephrothet can be administered via a separate infusion system or can be mixed under aseptic conditions with other parenteral nutrition components and inserted into a container.

    To compensate for the loss of amino acids during dialysis, Nephrotect can be administered without solutions of glucose and fatty emulsions directly into the venous trap of the dialysis apparatus.

    Nephrothet can be used as long as the patient needs parenteral nutrition or there is a need to make up for the loss of amino acids.

    Side effects:

    Side effects were not observed when observing the technique of administration, recommended doses and taking into account contraindications.

    In rare cases, with the introduction of any amino acid solution can be observed: increased eosinophil levels, muscle pains, scleroderma, puffiness of the extremities, difficulty breathing.

    Interaction:

    Amino acid solutions can be mixed under aseptic conditions only with preparations intended for parenteral nutrition, including fatty emulsions, glucose solutions, electrolytes.

    It is not recommended to co-administer with other drug groups because of the risk of incompatibility
    Special instructions:

    It is recommended to monitor the fluid balance, serum electrolyte level, acid-base index, urea and ammonium levels during therapy.

    Nephrotect can be mixed or injected in parallel with energy carriers, electrolytes, in quantities necessary to meet the patient's needs.

    The introduction of amino acids in parenteral nutrition in children with impaired renal function can be vital, in which case it is possible to use in children. Tyrosine is an indispensable amino acid for children.

    Before prescribing Nephrotext, children need to assess the risk / benefit ratio.

    Form release / dosage:

    Solution for infusion.

    Packaging:Solution for infusions of 250 or 500 ml in a vial of colorless hydrolytic glass, ukuporennom rubber (halobutilovoy) stopper and a rimmed aluminum cap with a plastic cap-control the first dissection. For 10 vials, together with plastic holders or without them in a carton box with instructions for use.
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Do not freeze!

    Keep out of the reach of children!

    Shelf life:

    2 years.

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-002526/07
    Date of registration:31.08.2007
    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: & nbsp31.01.2011
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