Aminoplasmal E10 (Aminoplasmal E10)

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

    1000 ml of solution contains:

    Active substances:

    Isoleucine 2,550 g

    Leucine 4,450g

    Lysine hydrochloride 3,500g

    (corresponds to lysine) 2,800g

    Methionine 1,900 grams

    Phenylalanine 2,550 g

    Threonine 2.050g

    Tryptophan 0,900g

    Valine 2,400g

    Arginine 4,600g

    Histidine 2,600g

    Alanin 6,850g

    Glycine 3,950

    Asparagine monohydrate

    1.860 grams

    (corresponds to asparagine)

    1.640 g

    Aspartic acid

    0.650 g

    Glutamic acid

    2,300 g

    Ornithine hydrochloride

    1,600 g

    (corresponding to ornithine)

    1.250 g

    Proline

    4,450 g

    Serin

    1,200 grams

    Tyrosine

    0.300 grams

    Acetyltyrosine

    0.430 g

    (corresponds to tyrosine)

    0.350 g

    Acetylcysteine

    0.340 g

    (corresponding to cysteine)

    0.250 g

    Sodium acetate trihydrate

    3.950 g

    Potassium acetate

    2.454 g

    Magnesium acetate tetrahydrate

    0.558 g

    Sodium dihydrogen phosphate dihydrate

    1.404 g

    Apple acid

    1.006 g

    Excipients:


    Sodium hydroxide

    0.200 g

    Disodium edetate dihydrate

    0.050 g

    Water for injections

    up to 1000 ml

    Concentration of electrolytes:

    Sodium

    43 mmol / l

    Potassium

    25 mmol / l

    Magnesium

    2.6 mmol / l

    Chlorides

    29 mmol / l

    Acetates

    59 mmol / l

    Malaty

    7.5 mmol / l

    Dihydrogen phosphates

    9 mmol / l

    Physico-chemical characteristics:

    Theoretical osmolality

    590 mOsm / l

    pH

    from 5.0 to 7.5

    Amino acid content

    50 g / l

    Total nitrogen

    8.0 g / l

    Caloric value

    835 kJ / l (200 kcal / l)
    Description:

    a clear, colorless or pale yellow solution

    Pharmacotherapeutic group:nutrition parenteral remedy
    ATX: & nbsp

    B.05.B.A   Solutions for parenteral nutrition

    Pharmacodynamics:

    Aminoplasmal E 5 contains amino acids that are a substrate for protein synthesis, and mineral substances necessary to maintain water-electrolyte and acid-base equilibrium.

    Intravenous amino acids enter the intravascular and intracellular depots of endogenous free amino acids and, like them, function as a substrate for the synthesis of body proteins. The introduction of all the amino acids necessary for protein synthesis (including conditionally replaceable and non-replaceable amino acids) contained in the preparation Aminoplasmal E 5 provides high nutritional efficiency and reduces the burden on the body during protein synthesis.

    Thus, the main therapeutic effect of the drug Aminoplasmal E 5 is to supply the body with a protein synthesis substrate for parenteral nutrition.

    Pharmacokinetics:

    In the preparation Aminoplasmal E 5 individual concentrations of amino acids are selected in this way,so that when the solution is injected intravenously, the relative increase in the concentration of each amino acid in the plasma does not go beyond the norm, which ensures the maintenance of the homeostasis of amino acids in the plasma.

    Bioavailability of all components of the drug Aminoplasmal E 5 with intravenous administration is 100 %.

    Indications:

    Parenteral nutrition in order to prevent and treat the conditions of protein deficiency due to increased loss of proteins and / or increased need for them:

    - Injuries of medium and severe degree, polytrauma, burns, peritonitis, sepsis;

    - Conditions after extensive surgical interventions;

    - Inflammatory bowel diseases (including Crohn's disease, ulcerative colitis), intestinal fistulas;

    - Disturbances in nutrition of different genesis (cachexia).

    Contraindications:

    - Severe circulatory disorders (shock);

    - Pulmonary edema;

    - Pronounced hypoxia or acidosis;

    - Hypersensitivity to the components of the drug;

    - Children under 2 years.

    Carefully:

    This drug can be used only after a thorough assessment of the expected positive effect and possible risk in patients with:

    - Congenital disorders of amino acid metabolism;

    - Hyperhydration;

    - Hyperkalemia;

    - Hyponatremia;

    - Increased plasma osmolality.

    Pregnancy and lactation:

    At present, there is no sufficient clinical data on the use of Aminoplasmal E 5 during pregnancy and lactation, so it is possible to use it in pregnant and lactating women only in cases when the expected benefit of treatment with the drug exceeds the possible risk of complications.

    Dosing and Administration:

    Aminoplasmal E 5 is introduced into the peripheral or central veins. The method of application of the preparation:

    The daily dose of Aminoplasmal E 5 should be determined individually, according to the patient's needs for amino acids, electrolytes and fluids.

    Beginning of the drug, you should gradually increase the speed and dose of administration to the calculated value.

    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.

    Doses

    Adults and children from 14 years of age

    Recommended daily dose:

    20-40 ml / kg of body weight, which corresponds to 1.0-2.0 g of amino acids / kg of body weight or 1400-2800 ml for a patient with a body weight of 70 kg.

    The highest daily dose:

    40 ml / kg of body weight, which corresponds to 2.0 g of amino acids / kg of body weight or 140 g of amino acids for a patient with a body weight of 70 kg.

    Maximum injection rate:

    2.0 ml / kg body weight / hour, corresponding to 0.1 g amino acids / kg body weight / hour or (calculated for a patient with a body weight of 70 kg) 45 drops per minute, corresponding to approximately 140 ml / hour.

    Children

    Recommended daily dose:

    For children from 2 to 5 years:

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

    For children from 5 to 14 years:

    20 ml / kg of body weight, which corresponds to 1.0 g of amino acids / kg of body weight.

    If the need for amino acids exceeds 1.0 g / kg body weight per day, more concentrated amino acid solutions may be used to reduce the water load.

    Maximum injection rate:

    2.0 ml / kg body weight / hour, which corresponds to 0.1 g of amino acids / kg body weight / h. Duration of use:

    Restrictions on the duration of use of the drug is not revealed.
    Side effects:

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

    Overdose:

    Overdose or too rapid introduction of the drug can cause such things as chills, nausea, vomiting and increased excretion of amino acids by the kidneys. The concentration of lactate and / or bilirubin in the blood may also increase.

    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 any other preparations into Aminoplasmal E5, preferably to include them in standard solutions of carbohydrates or electrolytes. However, it is possible to mix Aminoplasmal E5 with other solutions for parenteral nutrition after checking their compatibility.

    Special instructions:

    With complete parenteral nutrition Aminoplasmal E 5 should be used in combination with drugs that provide energy needs of the body (with fat emulsions and solutions of carbohydrates); the ratio of non-protein calories to introduced nitrogen should be 100-150 kcal / g of nitrogen.

    During the treatment it is necessary to control the water-electrolyte balance, plasma osmolality, acid-base balance, blood glucose concentration and liver function. Particularly careful monitoring is required by patients with:

    - disturbances in the metabolism of amino acids;

    - hepatic failure, because the deepening of neurological disorders can be associated with hyperammonemia;

    - renal failure, in particular in the presence of severe hyperkalemia, hyperaemia, as a result of decreased renal clearance;

    - adrenal insufficiency, cardiac or pulmonary insufficiency.

    With prolonged administration (within a few weeks), coagulation factors and the cellular composition of the blood should be monitored.

    For patients with hepatic, renal, cardiac, pulmonary insufficiency, as well as insufficiency of the adrenal cortex, it is necessary to select an individual dosing regimen.

    In the case of children, the age, nutritional status and underlying disease of the patient must be carefully considered. Simultaneously with the introduction of the amino acid composition, the use of other nutrients is indicated.In the case of complete parenteral nutrition, it is also necessary to introduce carbohydrates, essential fatty acids, vitamins and microelements. Duration of introduction from one bottle should not exceed 24 hours.

    Form release / dosage:

    Solution for infusion.

    Packaging:500 ml in bottles of hydrolytic glass class 2, sealed with a rubber stopper of brick color, meeting the requirements of the European Pharmacopoeia for infusion solutions, an aluminum cap of brick red color and a plastic cap of gray color.

    For 10 bottles together with instructions for use in an appropriate quantity in a cardboard box (for hospitals).

    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:For hospitals
    Registration number:П N012990 / 01
    Date of registration:05.11.2008
    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: & nbsp16.07.2009
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