Sterofundin G-5 (Sterofundin G-5)

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

1000 ml of solution contains:

Active substances:

Dextrose (glucose) monohydrate

55.00 grams

(corresponds to dextrose)

50.00 grams

Sodium chloride

7.60 g

Potassium chloride

0.30 g

Calcium chloride dihydrate

0.37 g

Magnesium chloride hexahydrate

0.20 g

Apple acid

1.34 g

Excipients:

Sodium hydroxide

0.40 g

Water for injections

up to 1000 ml

Concentration of electrolytes:

Sodium

140.0 mmol / l

Potassium

4.0 mmol / l

Calcium

2.5 mmol / L

Magnesium

1.0 mmol / L

Chlorides

141.0 mmol / l

Malaty

10.0 mmol / L

Physico-chemical characteristics:

Theoretical osmolality

576 mOsm / l

pH

from 3.0 to 5.0

Caloric value

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:

    With respect to the most important cations, the composition of the solution is similar to that of the blood plasma. In this regard, the solution is used to correct water-electrolyte disturbances. When electrolyte solutions are used, the osmotic balance is restored and / or maintained both inside and outside the cells. Malates oxidize and have a moderate alkaline effect. The solution contains 5% dextrose. At a daily dose of 40 ml / kg of body weight, the amount of dextrose administered is sufficient to cover the body's need of 2 g / kg of body weight / day (hypocaloric infusion therapy).

    Pharmacokinetics:

    Since Sterofundin G-5 is administered intravenously, the bioavailability of all its components is 100%.

    Sodium and chlorides are mainly distributed in the extracellular space, whereas potassium, magnesium and calcium are localized inside the cells. Sodium, potassium, magnesium and chlorides are excreted mainly through the kidneys, as well as in small amounts through the skin and gastrointestinal tract. Calcium is excreted in urine and endogenous intestinal secretion in approximately equal amounts.

    During the infusion of malates, their concentration in the blood plasma increases to a constant value. Then, after stopping the infusion, their concentration drops sharply. Excretion of malates with urine increases during infusion. However, the metabolism of malates in the tissues of the body is so rapid that only a small amount of it enters the urine.

    During the infusion dextrose 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 H2ABOUT. Glucose oxidation products are excreted by the lungs (CO2) and kidneys (H2ABOUT).

    Normally, glucose is not eliminated by the kidneys. Under pathological conditions (such as diabetes, impaired glucose tolerance) with hyperglycemia (blood glucose over 120 mg / 100 ml or 6.7 mmol / l) glucose excreted by the kidneys (glucosuria), when exceeded maximum glomerular filtration (180mg / 100 mL or 10 mmol / L).

    Indications:

    - Isotonic dehydration;

    - ghypotonic dehydration;

    - zthe replacement of the extracellular volume with an isotonic solution with a partial covering of the energy needs of the organism;

    - dTo dilute compatible concentrated solutions of electrolytes and other drugs.

    Contraindications:

    - Hyperhydration;

    - gand hypertonic dehydration;

    - gand apokalemia;

    - giperatremia;

    - gandperchloremia;

    - zabortions, which should limit sodium intake, such as heart failure; edema, pulmonary edema, hypertension, eclampsia, severe renal impairment;

    - sustained hyperglycemia, do not respond to short-acting insulin in a dose of up to 6 units per hour.
    Pregnancy and lactation:

    The drug can be used during pregnancy and during breastfeeding, but should not be administered with eclampsia.

    Dosing and Administration:

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

    Recommended doses

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

    Adults and children from 15 years of age

    The maximum daily dose is 40 ml / kg of body weight, which corresponds to 2.0 g of glucose / kg of body weight, 5.6 mmol of sodium / kg of body weight and 0.16 mmol of potassium / kg of body weight.

    The maximum rate of administration is 5 ml / kg body weight / hour, which corresponds to 0.25 g glucose / kg body weight / hour, 0.7 mmol sodium / kg body weight / hour and 20 μmol potassium / kg body weight / hour.

    For patients with a body weight of 70 kg, the maximum rate of administration is 350 ml / h or 120 drops / min. This corresponds to 17.5 g of glucose / hour, 49 mmol of sodium / hour and 1.4 mmol of potassium / hour.

    Children under 15 years

    Daily doses for children should be individually selected in accordance with the state of water-electrolyte balance and needs.

    When choosing doses for children under 15, the following limitations on the maximum daily volume of injected liquid and glucose, as well as the maximum rate of glucose administration, should be taken into account.

    The maximum daily volume of injected liquid:

    - Children in 1 day of life 50-70 ml / kg of body weight;

    - children in the 2nd day of life 70-90 ml / kg body weight;

    - children in the 3rd day of life 80-100 ml / kg body weight;

    - children in the 4th day of life 100-120 ml / kg body weight;

    - children from 5 days of life 100-150 ml / kg body weight;

    - children from the first year of life 100-140 ml / kg of body weight;

    - children from the second year of life 80-120 ml / kg body weight;

    - Children from 3 years of age to 5 years of age, including 80-100 ml / kg of body weight;

    - Children from 6 years to 10 years of age, including 60-80 ml / kg of body weight;

    - for children from 11 years to 14 years of age, 50 to 70 ml / kg of body weight.

    Maximum Daily Glucose Dose

    - children from 1 year to 2 years of age, 12-15 g glucose / kg body weight:

    - children from 3 years to 5 years, inclusive 12 g glucose / kg body weight;

    - children from 6 years to 10 years, inclusive 10 g glucose / kg body weight;

    - children from 11 years to 14 years of age, including 8 g of glucose / kg of body weight.

    The maximum rate of glucose administration

    - children from 1 year to 2 years of age, including 8-10 mg glucose / kg body weight / min;

    - children from 3 years to 5 years inclusive 8-10 mg glucose / kg body weight / min;

    - children from 6 years to 10 years inclusive 8-10 mg glucose / kg body weight / min;

    - children from 11 years to 14 years of age, including 5-6 mg glucose / kg body weight / min.

    Duration of application

    The solution can be used for several days. The 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 administration of such doses dextrose 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 operations or trauma, hypoxic stress or organ failure, the daily dose should be reduced to 200-300 g, which corresponds to 3 g / kg body weight / day. The selection of individual doses includes mandatory laboratory monitoring.

    The following adult dose limits should be strictly observed: 0.25 g of dextrose / kg of body weight / hour and up to 6 g / kg of body weight / day. The administration of solutions containing carbohydrates, regardless of concentration, should always be accompanied by a control of the concentration of glucose in the blood both during surgery and in the 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

    A dose of 30 ml of solution / kg of body weight / 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:

    Volume overload and an overdose of electrolytes.

    Symptoms

    Overdose of the drug may lead to such phenomena as hypertonic hyperhydration, electrolyte disorders, pulmonary edema.

    Treatment

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

    Overdose of dextrose

    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 the concentration of glucose in the blood; replacement of losses of electrolytes, monitoring of acid-base equilibrium.

    Interaction:

    To avoid incompatibility, the following preparations should not be mixed with the preparation Sterofundin G-5:

    - preparations forming a precipitate when mixed with the components of the solution;

    - preparations containing salts of weak organic acids of alkali or alkaline earth metals, poorly soluble in water;

    - unstable, decomposing or losing efficacy in an acidic environment medicines.

    Special instructions:

    The solution should not be administered through the same infusion system at the same time, before or after the blood transfusion because of the possible occurrence of pseudoagglutination.

    In comparison with healthy people, glucose tolerance is lower in patients with metabolic changes characteristic of the post-operative or post-traumatic period. The older the patient, and the heavier his underlying disease, operation or trauma, the more likely metabolic disorders associated with a violation of glucose tolerance, similar to diabetes mellitus, can develop.

    Clinical monitoring should include monitoring of water-Electrolyte balance, in particular the concentration of potassium. At different states with a violation of glucose tolerance (hyperglycemia), it is necessary to monitor the concentration of glucose in the blood.

    Do not freeze!

    Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles, mechanisms, as well as engage in potentially hazardous activities,requiring increased concentration of attention and psychomotor reactions
    Form release / dosage:Solution for infusion.
    Packaging:

    By 500 ml or 1000 ml in bottles made of polyethylene without additives meeting 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, along with instructions for use in an appropriate amount 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-000968
    Date of registration:11.10.2011
    The owner of the registration certificate:B. Brown Medical AGB. Brown Medical AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp07.03.2016
    Illustrated instructions
      Instructions
      Up