Normofundin G-5 (Normofundin G-5)

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

1000 ml of solution contains:

Active substances:

55,000 g

Dextrose (glucose) monohydrate

(corresponds to dextrose)

50,000 grams

Sodium chloride

3,630 g

Potassium chloride

1.340 g

Calcium chloride dihydrate

0.295 g

Magnesium chloride hexahydrate

0.610 g

Sodium acetate trihydrate

5.170 g

Excipients:

A solution of 2 M hydrochloric acid

from 0 to 2 g

Acetic acid solution 2 M

from 0 to 1 g

Water for injections

up to 1000 ml

Concentration of electrolytes:

Sodium

100.0 mmol / l

Potassium

18.0 mmol / l

Calcium

2.0 mmol / L

Magnesium

3.0 mmol / L

Chlorides

90.0 mmol / L

Acetates

38.0 mmol / l

Physico-chemical characteristics:

Theoretical osmolarity - 530 mOsm / l

pH is from 4.5 to 7.5

Caloric content is 835 kJ / l (200 kcal / l)

Description:A clear, colorless or pale yellow solution.
Pharmacotherapeutic group:rehydrating agent
ATX: & nbsp
  • Electrolytes in combination with carbohydrates
    • Pharmacodynamics:

    The preparation is an electrolyte solution with a total cation number of 123 mmol / l. Such a composition was chosen on the basis of the need to compensate for the disturbances in the electrolyte metabolism of the organism during metabolic stress. To this end, in comparison with solutions of electrolytes, whose composition is close to the blood plasma, the amount of sodium is reduced in order to prevent sodium and liquid retention, but at the same time,to prevent the development of secondary hyperaldosteronism.

    Sufficiently high concentrations of potassium compared with solutions of electrolytes close in composition to plasma due to increased demand of an organism in potassium arising in stressful situations under conditions adequate compensation for the fluid volume of about 1 mmol potassium / kg body weight / day.

    Acetates have an alkalizing effect during oxidation. Anionic composition is represented by a balanced combination of chlorides that are not metabolized, and acetates, which are metabolized and interfere with the development of metabolic acidosis.

    In addition, the solution contains 5% glucose. From a physiological point of view, glucose is the primary source of energy with a caloric value of about 16 J / g or 3.75 kcal / g. Providing body glucose necessary for the functioning of the nervous system tissues, erythrocytes and kidney medulla.

    On the one hand, glucose is converted to glycogen for carbohydrate reserves, on the other hand, is metabolized in the process of glycolysis to pyruvate or lactate to provide energy for cells.

    There is a close relationship between electrolytes and the metabolism of carbohydrates. Assimilation glucose and increased demand for potassium are related. If this is not taken in consideration, this can lead to a disruption in the exchange of potassium, which, in turn, can cause severe cardiac rhythm disturbances.

    Some pathological conditions can lead to disruption of assimilation processes glucose intolerance, for example, diabetes mellitus or conditions in which "stress-metabolism" is observed, leading to (a decrease in glucose tolerance (severe complications of the operating or postoperative period, trauma) .This can lead to hyperglycemia, which, in turn, may, depending on the degree of "severity, lead to an osmotic diuresis followed by development of hypertensive dehydration and hyperosmotic violations up to a hyperosmotic coma.

    Excessive administration of glucose, especially in conditions accompanied by a decrease tolerance to glucose, can lead to a serious disruption of glucose uptake and, due to the limitation of the oxidative assimilation of glucose, to a greater transition glucose to fat. This, in turn, may be accompanied by a higher level CO2 in the body (problems associated with shutting down the ventilation), as well as increased infiltration of fat in tissues, especially in the liver. Particularly at risk disorders of homeostasis of glucose patients with craniocerebral trauma or brain edema. AT In these cases, even insignificant violations of glucose concentration in blood and, consequently, an increase in the osmolality of the blood plasma (serum) can lead to significant increases in brain damage.

    A dose of 40 ml / kg of body weight / day covers the necessary body needs in carbohydrates, equal to 2 g glucose / kg body weight / day (hypocaloric infusion therapy).

    Pharmacokinetics:

    During the infusion, glucose firstly enters the intravascular space with subsequent movement into the intercellular space. In the process of glycolysis, glucose is converted into pyruvate or lactate. Further, lactate is partly involved in the reactions of the Krebs cycle. Pyruvate is completely oxidized by oxygen to CO2 and H2O. Glucose oxidation products are excreted by the lungs (CO2 ) and kidneys (H2ABOUT).

    Normally, glucose is not eliminated by the kidneys.In patients with pathological conditions (such as diabetes mellitus, decreased glucose tolerance) with hyperglycemia (glucose concentration in the blood of more than 120 mg / ml or 6.7 mmol / L), glucose is excreted by the kidneys (glucosuria) when maximal glomerular filtration (180 mg / 100 ml or 10 mmol / l).

    Indications:

    - Hypertonic dehydration;

    - isotonic dehydration;

    - providing the body with liquid and electrolytes with partial coverage of energy needs during the infusion therapy in the postoperative and post-traumatic period;

    - for dilution of compatible concentrated solutions of electrolytes and other drugs.

    Contraindications:

    - Hyperhydration;

    - hypotonic dehydration;

    - hyperkalemia;

    - children under the age of 14 years.

    Carefully:

    Normofundin G-5 should be used with caution in the following cases:

    - hyponatremia;

    - renal failure with a tendency to hyperkalemia;

    - hyperglycemia, not stopping with insulin in a dose of up to 6 units / hour.

    Pregnancy and lactation:

    It is possible to use the drug Normofundin G-5 in pregnant and lactating women in cases when the expected benefit from treatment with the drug exceeds the possible risk of complications.

    Dosing and Administration:

    Normofundin G-5 is injected into the peripheral and central veins.

    Recommended doses

    The dose of the drug depends on the level of glucose in the blood, the patient's need for fluids and electrolytes.

    The maximum daily dose

    Elderly, adults and children from the age of 14 years 40 ml / kg body weight, corresponding to 2.0 g glucose / kg body weight, 4 mmol sodium / kg body weight and 0.7 mmol potassium / kg body weight.

    Maximum injection rate

    5 ml / kg body weight / hour or 1.6 drops / kg body weight / min, which corresponds to 0.25 g glucose / kg body weight / hour.

    Duration of application

    The solution can be used for several days. Duration of application is determined by the clinical condition of the patient and laboratory indicators.

    General recommendations for the use of carbohydrates

    Under normal metabolism, the total amount of carbohydrates administered should not exceed 350-400 g per day. With the introduction of such doses, glucose is fully absorbed.

    The appointment of higher doses may cause the development of adverse side effects and lead to fatty liver infiltration. In conditions of disturbed metabolism, for example, after extensive surgery or trauma, hypoxic stress or organ failure, the daily dose should be reduced to 200-300 g, which corresponds to 3 g / kg of body weight / day.The selection of individual doses includes mandatory laboratory monitoring.

    The following adult dose limits should be strictly observed: 0.25 g glucose / kg body weight / hour and up to 6 g / kg body weight / day. The administration of solutions containing carbohydrates, regardless of concentration, should always be accompanied by monitoring of blood glucose level in both operative intervention and conservative management of the patient. To prevent overdose of carbohydrates, it is recommended to use infusion pumps, especially when using solutions with a high concentration of carbohydrates.

    General recommendations for the use of liquid and electrolyte solutions

    Dose 30 ml of solution / kg of body weighta/ day covers only the physiological needs of the body in the liquid. In patients undergoing surgery and patients in critical conditions, fluid requirements increase due to reduced renal concentration function and increased excretion of metabolic products, which leads to the need to increase fluid intake to about 40 ml / kg body weight / day.

    Additional losses (fever, diarrhea, fistula, vomiting, etc.) must be compensated for by an even higher injection of liquid, the level of which is set individually.

    The actual individual level of fluid demand is determined by sequential monitoring of clinical and laboratory indicators (urine output, serum and urine osmolality, determination of excreted substances).

    The main replacement of the most important sodium and potassium cations is 1.5-3.0 mmol / kg body weight / day and 0.8-1.0 mmol / kg body weight / day, respectively.

    The actual requirements for infusion therapy are determined by the state of the water-electrolyte balance.
    Side effects:

    If all the recommendations for dose and speed of administration of the drug are met, adverse side effects do not occur.

    Overdose:

    Symptoms

    Overdosing of the drug may entail such phenomena as hyperhydration with increased skin turgor, venous congestion and development of general edema followed by the development of pulmonary edema.

    Treatment

    Immediate discontinuation of infusion, the appointment of diuretics, continuous monitoring of plasma electrolytes; correction of electrolyte level.

    Overdose of glucose

    Symptoms

    Hyperglycemia, glucosuria, dehydration, hyperosmolarity of the serum, hyperglycemic or hyperosmolar coma.

    Treatment

    Immediate cessation of infusion; rehydration, the appointment of insulin with a constant control of blood glucose levels; replacement of losses of electrolytes, monitoring of acid-base equilibrium.

    Interaction:

    To avoid the formation of sediment, the preparation NormoFundin G-5 should not be mixed with preparations containing oxalates, phosphates, carbonates or hydrogen carbonates.

    Suxamethonium and potassium can be negative in their joint appointment influence on the heart rhythm due to pronounced hyperkalemia.

    Special instructions:

    Clinical monitoring should include monitoring the water-electrolyte balance.

    In the presence of arterial hypertension, the administration of sodium chloride and fluid volume should be carried out individually.

    For the elderly, it is necessary to reduce the dose of the drug administered due to the danger of overloading the volume.

    The solution should not be administered via the same systems for transfusion, concurrently, before or after the introduction of blood due to the risk of pseudoagglutination.

    Only a solution containing 70 mmol / l of sodium can be used for the treatment of hypertensive dehydration. Correction of dehydration should be carried out for at least 48 hours.

    The administration of the solution in post-operation, post-traumatic or other conditions accompanied by impaired glucose tolerance should be carried out under the condition of constant monitoring of glucose concentration.

    If necessary, the appointment of insulin is recommended.

    Do not freeze!

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

    The drug does not affect the ability to drive vehicles, mechanisms, and engage in potentially hazardous activities that require increased concentration of attention and psychomotor reactions.

    Form release / dosage:Solution for infusion.
    Packaging:

    By 500 ml or 1000 ml into bottles of polyethylene without additives, which meet the requirements of the European Pharmacopoeia for parenteral preparations. The bottle is welded with a polyethylene cap with two holes in the upper part, under which there is a rubber disc; each of the holes is sealed with foil.

    For 10 bottles of 500 ml or 1000 ml, together with instructions for use in corresponding quantity in a cardboard box (for hospitals).

    Storage conditions:

    Store at a temperature of 2 to 25 ° C.

    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:LS-000969
    Date of registration:03.10.2011
    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: & nbsp09.03.2016
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