Sterofundin g5 instructions and description for the drug. Medicinal reference book geotar Normofundin g 5 instructions for use

Dosage form:  solution for infusion Compound:

1000 ml solution contains :

Active ingredients:

55,000 g

Dextrose (glucose) monohydrate

(corresponds to dextrose)

50,000 g

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:

Hydrochloric acid solution 2 M

from 0 to 2 years

Acetic acid solution 2 M

0 to 1 g

Water for injections

up to 1000 ml

Electrolyte concentration:

Sodium

100.0 mmol/l

Potassium

18.0mmol/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 - from 4.5 to 7.5

Calorie content - 835 kJ / l (200 kcal / l)

Description: Clear, colorless or pale yellow solution. Pharmacotherapeutic group:rehydrator ATX:  
  • Electrolytes combined with carbohydrates
  • Pharmacodynamics:

    The drug is an electrolyte solution with a total amount of cations equal to 123 mmol/L. Such a composition was selected based on the need to compensate for electrolyte imbalances in the body during metabolic stress. To this end, in comparison with electrolyte solutions, the composition of which is close to blood plasma, the amount of sodium is reduced in order to prevent the retention of sodium and fluid, but at the same time remains sufficient to prevent the development of secondary hyperaldosteronism.

    A rather high concentration of potassium in comparison with electrolyte solutions close in composition to blood plasma is due to the increased need of the body for potassium that occurs during stressful situations under conditions of adequate replacement of the volume of fluid, which is approximately 1 mmol potassium/kg body weight/day.

    Acetates, when oxidized, have an alkalizing effect. The anionic composition is represented by a balanced combination of chlorides that are not metabolized, and acetates, which are metabolized and prevent the development of metabolic acidosis.

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

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

    There is a close relationship between electrolytes and carbohydrate metabolism. assimilationglucose and an increased need for potassium are linked. If it's not acceptedinto account, this can lead to a violation of potassium metabolism, which, in turn,can cause severe cardiac arrhythmias.

    Some pathological conditions can lead to disruption of the assimilation processesglucose (glucose intolerance), for example, such as diabetes mellitus or conditions in which there is a "stress metabolism" leading to (decreased glucose tolerance (severe complications of the surgical or postoperative period, trauma). This can lead to hyperglycemia, which, in turn, may, depending on the severity, lead to osmotic diuresis with subsequentdevelopment of hypertensivedehydration and hyperosmoticdisorders up to hyperosmotic coma.

    Excessive administration of glucose, especially in conditions accompanied by a decrease glucose tolerance can lead to severe impairment of glucose uptake and,due to the restriction of oxidative glucose uptake, to a greater transitionglucose to fat. This, in turn, may be accompanied by a higher level CO 2 in the body (problems associated with turning off ventilation), as well as increasedinfiltration of fat into tissues, especially the liver. Particularly at riskdisorders of glucose homeostasis in patients with traumatic brain injury or cerebral edema. INIn these cases, even slight disturbances in the concentration of glucose in blood and therefore, an increase in plasma (serum) osmolarity can lead tomarked increase in brain damage.

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

    Pharmacokinetics:

    During infusion, glucose first enters the intravascular space, followed by movement into the extracellular space. During glycolysis, glucose is converted to pyruvate or lactate. Further, lactate is partially involved in the reactions of the Krebs cycle. Pyruvate is completely oxidized by oxygen to CO 2 and H 2 O. The products of glucose oxidation are excreted by the lungs (CO 2 ) and the kidneys (H 2 O).

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

    Indications:

    Hypertensive dehydration;

    Isotonic dehydration;

    Providing the body with liquid and electrolytes with partial coverage of energy needs during 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's age up to 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 stopped by insulin at 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 where the expected benefit from drug treatment outweighs the possible risk of complications.

    Dosage and administration:

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

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

    Maximum daily dose

    Elderly, adults and children from 14 years of age 40 ml/kg body weight, which corresponds 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 determined by the clinical condition of the patient and laboratory parameters.

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

    The appointment of higher doses may cause the development of adverse reactions and lead to fatty infiltration of the liver. In conditions of impaired metabolism, for example, after major operations or injuries, 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 dose limits for adults must be strictly observed: 0.25 g glucose/kg body weight/hour and up to 6 g/kg body weight/day. The appointment of solutions containing carbohydrates, regardless of concentration, should always be accompanied by monitoring the level of glucose in the blood, both during surgery and in the conservative management of the patient. The use of infusion pumps is recommended to prevent carbohydrate overdose, especially when using solutions with a high concentration of carbohydrates.

    A dose of 30 ml solution/kg body weight/day covers only the physiological needs of the body for fluid. In postoperative and critically ill patients, fluid requirements are increased due to reduced renal concentrating function and increased excretion of waste products, resulting in the need to increase fluid intake to approximately 40 ml/kg body weight/day.

    Additional losses (fever, diarrhoea, fistulas, vomiting, etc.) must be compensated for by even higher fluid administration, the level of which is set individually.

    The actual individual level of fluid requirement is determined by consistent monitoring of clinical and laboratory parameters (urine excretion, serum and urine osmolarity, 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 needs for infusion therapy are determined by the state of the water and electrolyte balance.

    Side effects: Overdose:

    Symptoms

    An overdose of the drug can lead to such phenomena as hyperhydration with an increase in skin turgor, venous congestion and the development of general edema, followed by the development of pulmonary edema.

    Treatment

    Immediate cessation of infusion, prescription of diuretics, continuous monitoring of plasma electrolytes; correction of the level of electrolytes.

    Glucose overdose

    Symptoms

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

    Treatment

    Immediate cessation of infusion; rehydration, administration of insulin with constant monitoring of blood glucose levels; replacement of electrolyte losses, monitoring of acid-base balance.

    Interaction:

    To avoid the formation of a precipitate, Normofundin G-5 should not be mixed with preparations containing oxalates, phosphates, carbonates or bicarbonates.

    Suxamethonium and potassium, when administered together, may have a negative effect on heart rate due to severe hyperkalemia.

    Special instructions:

    Clinical monitoring should include monitoring of fluid and electrolyte balance.

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

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

    The solution should not be administered through the same transfusion systems, simultaneously, before or after blood administration due to the risk of pseudo-agglutination.

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

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

    Do not freeze!

    Influence on the ability to drive transport. cf. and fur.:

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

    Release form / dosage:Solution for infusion. Package:

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

    10 bottles of 500 ml or 1000 ml each with instructions for use in the 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.

    Best before date:

    Do not use after the expiry date stated on the packaging.

    Conditions for dispensing from pharmacies: For hospitals Registration number: LS-000969 Date of registration: 03.10.2011 Registration certificate holder:B. Braun Melsungen AG Germany Manufacturer:   Representation:  B.Brown Medical, LLC Information update date:   09.03.2016 Illustrated Instructions

    Or saline- a means of maintaining blood and intercellular pressure in the body. Sodium chloride dropper is used for hypohydration and intoxication of the body, with a decrease in blood volume.

    Sodium chloride - solution for intravenous administration

    Composition and price of sodium chloride

    A solution of sodium chloride, or saline, is a colorless, salty liquid that does not have a pronounced odor. There are 2 types of saline with different concentrations of NaCl: 0.9% isotonic, and 10% hypertonic.

    The composition of the product for 1 liter:

    There are several forms of release of saline:


    Sodium chloride storage conditions: store in a dry place, out of the reach of children and pets, at a temperature of +18 to +25 degrees. The shelf life of the product is 5 years.

    The cost of the solution depends on the form of release, volume and manufacturer. Average prices are:

    1. In ampoules: 30-325 rubles.
    2. In bottles and packages: 25-60 rubles.
    3. Hypertonic saline solution: 80-220 rubles.

    From pharmacies, the drug is dispensed by prescription of the attending physician.

    How is sodium chloride useful for the body?

    Chlorinated sodium is present in the blood plasma and tissue fluids of the human body. It is responsible for the stability of the osmotic pressure of the intercellular fluid and blood. With a shortage of this substance, water leaves the vascular bed and passes into the interstitial fluid.

    This causes the following conditions:

    • increased blood density;
    • spasms of smooth, skeletal muscles;
    • neurological pathologies;
    • disorders of the cardiovascular system.

    Infusion management of saline returns the water-salt balance to normal, and also cleanses the body of toxins and decay products resulting from the vital activity of harmful bacteria.

    External use of NaCl improves the release of pus, restores the microflora, and destroys pathogenic microorganisms of various origins.

    In addition, chlorinated sodium improves the absorption of drugs. Patients are often put on a drip with intravenous drugs diluted with saline.

    pharmachologic effect

    Sodium chloride is used as a detoxification, rehydration and plasma-substituting agent. Its use is accompanied by the following effects:

    • normalization of the balance of water and salt;
    • replenishment of the lack of Na and Cl;
    • temporary increase in blood volume;
    • increased urination to cleanse the body.

    Due to the improved bioavailability of most drugs, saline is used in medicine as a dilution agent for injections and infusions.

    Saline as a basis for injection and infusion preparations

    It is incompatible or poorly compatible with the following medicines:

    • norepinephrine;
    • corticosteroids;
    • leukopoiesis stimulator Filgrastim;
    • antibiotic polymyxin B.

    With arterial hypertension, sodium chloride should not be combined with Enapril and Spirapril: the use of saline reduces the hypotensive effect of these drugs.

    Saline solution has an osmotic pressure similar to that of a human blood medium, and therefore is quickly excreted from the body. Within 1 hour after using the dropper, less than half of the product remains in the body.

    What is physiological saline used for?

    Physiological saline is administered intravenously in the form of infusions for indications:

    1. Severe and critical dehydration of the body, violation of the water-salt balance.
    2. Decrease in plasma volume with large blood loss, dyspepsia, severe burns, diabetic coma.
    3. Surgical manipulations, postoperative period.
    4. Intoxication of the body with infections and poisonings of various origins.
    5. Epigastric, ileocecal, pulmonary bleeding.
    6. Pathologies of digestion: nausea, vomiting, diarrhea, chronic and acute constipation.
    7. Lack of Na and Cl in the body.

    With the introduction of saline droppers with additional components, the list of indications expands.

    Instructions for use for a dropper

    Before the introduction of sodium chloride inside, it must be heated to a temperature of 36-38 degrees. The dosage of the drug is calculated individually, based on the patient's condition, history, age and weight.

    The average daily dosage of the drug varies in the values:

    1. Adults: 500-3000 ml.
    2. During pregnancy: 300-1200 ml.
    3. Children: 20-100 ml per kg of body weight.

    To instantly replenish the lack of Na and Cl, 100 ml is administered once.

    The average dropper speed is 540 ml/h. Hypertonic saline is administered by jet.

    Jet injection of saline

    For dilution and drip administration of other drugs, from 50 to 250 ml of saline is used per dose of the drug.

    Side effects

    Rare adverse effects that occur with prolonged or heavy use of sodium chloride include:


    When such complications occur, the introduction of saline is stopped, the patient is assisted to eliminate side effects.

    Contraindications for intravenous administration

    Infusion of saline is prohibited in such pathologies:


    Dropper with saline solution- a quick and effective way to replenish the volume of blood in the body, restore the water-salt balance, cleanse from toxins and toxins. So that the remedy does not cause a negative reaction, it should be used exclusively under the supervision of a physician.

    Instructions for the medical use of the drug

    Description of the pharmacological action

    The drug is an electrolyte solution with a total amount of cations equal to 123 mmol/l, whose composition was selected based on the need to compensate for violations of the mineral composition of the body during metabolic stress. To this end, in comparison with electrolyte solutions close to plasma in composition, the amount of sodium is reduced in order to prevent the retention of sodium and liquid.

    Indications for use

    Hypertensive dehydration;

    Isotonic dehydration;

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

    For dilution of concentrated solutions of electrolytes and medicines.

    Release form

    rozchin for infusions; a bottle (bottle) of polyethylene 100 ml, a box (box) of cardboard 20;

    Pharmacodynamics

    Achieve a high concentration of potassium in the proportions of electrolytes, close to plasma, in order to increase the body's consumption of potassium in stressful situations, with adequate replacement with potassium, which is approximately 1 mmol / kg of body weight / up to bu.

    Acetate oxidizes and has a puddle effect. The warehouse of anionic representations is a balanced combination of chlorides, which are not metabolized, and acetates, which are metabolized and change the development of metabolic acidosis.

    In addition, the difference in carbohydrates seems to be 5% the difference in glucose. From a physiological point of view, glucose is the primary source of energy with a caloric value of close to 16 kJ or 3.75 kcal / g. ї Nirok speeches.

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

    Between electrolytes and metabolism in carbohydrates, this is a close relationship.

    Assimilated glucose and increased the need for potassium "together with each other. If you don't take it to the point of respect, then you can lead to a breakdown in the exchange of potassium, for example, in your own hands, you can also cause a violation of the heart rhythm.

    Active pathological states can lead to disruption of the processes of glucose uptake (glucose intolerance), for example, such diseases as diabetes mellitus or become ill, if stress metabolism is suspected, lead to a decrease in tolerance to glucose (important aggravation of the operative or post-operative period, trauma). It can lead to hyperglycemia, yak, in its own line, it can - fallow in the degree of manifestation - lead to osmotic diuresis with a further development of hypertensive dehydration and hyperosmotic disorders right up to hyperosmogic coma.

    Overworld administration of glucose, especially in states that are accompanied by a decrease in tolerance to glucose, can lead to a serious impairment of glucose uptake and a decrease in the oxidation of glucose uptake, to a greater transition of glucose into fat. Tse, in my hand, can be accompanied by a higher level of CO2 in the body (problems, caused by the inclusion of SHVL), as well as increased fat infiltration in the tissue, especially in the liver. meostasis glucose and craniocerebral disease In these cases, an insignificant impairment of the concentration of glucose in the blood and, later, an increase in the osmolarity of the plasma (sirovatka) can lead to an increase in the severity of cerebral lesions.

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

    Pharmacokinetics

    Under the hour of infusion, glucose in the first place should be near the internal vascular space with advancing movements near the intercellular space. In the process of glycolysis, glucose is converted into pyruvate or lactate. Dali lactate often takes part in the reactions of the Krebs cycle. Pyruvate is more oxidized with acid to CO2 and H2O. Glucose oxidation products are light (CO2) and nirks (H2O). In norm, glucose is not eliminated by drugs. In pathological states (such as diabetes mellitus, reduced tolerance to glucose) with hyperglycemia (blood glucose concentration is more than 120 mg / ml or 6.7 mmol / l), glucose is administered by nirks (glucosuria), if the maximum glomerular fi is exceeded ltration (180 mg / 100 ml or 10 mmol/l).

    Use during pregnancy

    There are no clear contraindications. Tim is not less, victorious with vagity and lactation, if the melancholy for the mother outweighs the potential risk for the fetus or the newly born.

    Contraindications for use

    Hyperhydration;

    Hypotonic dehydration;

    Hyperkalemia.

    Protective: with hyponatremia, nirk deficiency with a tendency to hyperkalemia, hyperglycemia are not cured by insulin at a dose of up to 6 units / g.

    Side effects

    Dosage and administration

    For intravenous administration (central or peripheral access).

    The dose is selected individually according to the needs of the sick person in the same electrolytes.

    Maximum daily dose: up to 40 ml/kg body weight/dob, 2.0 g glucose/kg body weight/dob, 4 mmol sodium/kg body weight/dob and 0.7 mmol calcium/kg body weight/db.

    Frequency of administration: up to 5 ml / kg body weight / year, usually 0.25 g glucose / kg body body weight / year. Freshness of introduction - 1.6 droplets / kg body fat / min.

    Trivality vikoristannya:

    Rozchin can vikoristovuvatisya protyazh dekіlkoh days. Trivality vikoristannya is recognized by the clinical camp of the sick and laboratory indicators.

    With normal metabolism, the total amount of introduction of carbohydrates is not guilty of overtaking 350-400 g / doba. At the introduction of such doses, glucose is more oxidized. The use of higher high doses can lead to the development of side effects and lead to fatty liver infection. In case of broken metabolism, for example, after major operations or injuries, hypoxic stress or organ failure, the daily dose of the guilty buti is changed to 200-300 g, which is 3 g / kg body mass / dobu. The selection of individual doses includes obov "tongue laboratory monitoring.

    It is necessary to take precautionary doses for older adults: 0.25 g of glucose / kg of body weight / year and up to 6 g / kg of body weight / dobu. Appointment razchinіv, scho vengeance in carbohydrates - regardless of the concentration of zavzhda is guilty of supervising the concentration of glucose in the blood, both in case of surgical intervention, and in the case of conservative management of the disease. To prevent an overdose of carbohydrates, it is recommended to use alternative infusion pumps, especially in cases of high concentrations of carbohydrates.

    Riven 30 ml retail / kg oil body / dobu cover only the physiological needs of the body in the country. In sick people who have undergone surgery, and in resuscitation patients, the needs in the homeland increase in the "tongue with a changed concentration function of the blood and increased excretion of the products of the exchange, which leads to the need for zb It is necessary to reduce the amount of water to approximately 40 ml / kg body weight / extract. (fever, diarrhoea, fistula, vomiting, etc.) it is necessary to compensate for more high doses of the rіdini, the rіvіnіy іkої stаnіvієєєєєєєє іndivіdіvієєі. ico-laboratory indications (viewing the section, osmolarity of the serum and section, speeches are seen).

    The main substitution of the most important cations for sodium and potassium reaches 1.5-3 mmol per kg / body mass / extract and 0.8-1.0 mmol / kg mass body / extract is viable. Actual consumption during infusion therapy is determined by the electrolyte balance and monitoring of the concentration of electrolytes in plasma.

    Overdose

    Symptoms: an overdose of the drug can cause such phenomena, as hyperhydration with increased turgor of the skin, venous congestion and development of severe swelling with a distant development of swelling of the lungs.

    Investigation: follow a negligent infusion, use diuretics during continuous monitoring of blood plasma electrolytes; correction of the electrolyte balance.

    Glucose overdose

    Symptoms: hyperglycemia, glucosuria, dehydration, hyperosmolarity of the serosa, hyperglycemia or hyperosmolar coma.

    Likuvannya: follow the negain to infuse; carrying out registration; recognition of insulin with constant control of blood glucose; replacement of electrolyte intake, monitoring of acid-lub balance.

    Interactions with other drugs

    Suxamethonium and potassium, in case of severe symptoms, can cause a negative impact on the heart rhythm in patients with pronounced hyperkalemia.

    Special instructions for admission

    Clinical monitoring is to include control of electrolytes in blood serum and water balance.

    In the presence of hypertension, the admission to sodium chloride and about "emu rіdini is carried out individually.

    For a special summer age, it is necessary to reduce the dose of the drug, which is to be administered at the same time with a slight overwhelm of the volume.

    Rozchin is not guilty of being injected through the same systems for transfusion, one hour, until or after the introduction of blood after the risk of pseudoaglutination.

    Only rozchins, scho to take 70 mmol / l sodium, can be used for therapy of hypertensive dehydration. Correction of dehydration is due to be carried out no less than 48 hours. The introduction of a difference in postoperative, post-traumatic or other states with impaired tolerance to glucose must be carried out for the mind and constant monitoring of glucose concentration.

    Storage conditions

    At temperatures not higher than 25 ° C (Do not freeze).

    Best before date

    Belonging to ATX-classification:

    ** The Medication Guide is for informational purposes only. For more information, please refer to the manufacturer's annotation. Do not self-medicate; Before you start using the drug Normofundin G-5, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace the advice of a doctor and cannot serve as a guarantee of the positive effect of the drug.

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    Producers: B. Braun Melsungen (Germany)

    Active ingredients

    • Dextrose
    • Potassium chloride
    • Sodium chloride
    • Sodium acetate

    Disease class

    • Diarrhea and gastroenteritis of suspected infectious origin

    Clinical and pharmacological group

    • Not indicated. See instructions

    Pharmacological action

    • Detoxifying

    Pharmacological group

    • Means for enteral and parenteral nutrition

    Solution for infusion Normofundin G-5 (Normofundin G-5)

    Instructions for the medical use of the drug

    • Indications for use
    • Release form
    • Pharmacodynamics of the drug
    • Pharmacokinetics of the drug
    • Contraindications for use
    • Side effects
    • Dosage and administration
    • Overdose
    • Special instructions for admission
    • Storage conditions
    • Best before date

    Indications for use

    Hypertensive dehydration;

    Isotonic dehydration;

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

    For dilution of concentrated solutions of electrolytes and medicines.

    Release form

    solution for infusion; bottle (bottle) polyethylene 100 ml, cardboard box (box) 20;

    Pharmacodynamics

    Sufficiently high concentration of potassium in comparison with electrolyte solutions close to plasma reflects the increased need of the body for potassium in stressful situations, with adequate replacement of fluids, which is approximately 1 mmol/kg of body weight/day.

    Acetate oxidizes and has an alkalizing effect. The composition of anions is represented by a balanced combination of chlorides, which are not metabolized, and acetates, which are metabolized and prevent the development of metabolic acidosis.

    In addition, the solution contains carbohydrates in the form of a 5% glucose solution. From a physiological point of view, glucose is the primary energy source with a caloric value of about 16 kJ or 3.75 kcal/g. Providing the body with glucose is necessary for the functioning of the tissues of the nervous system, red blood cells, and the medulla of the kidneys.

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

    There is a close relationship between electrolytes and carbohydrate metabolism.

    Glucose uptake and an increased need for potassium are linked. If this is not taken into account, then this can lead to a violation of potassium metabolism, which, in turn, can cause severe heart rhythm disturbances.

    Some pathological conditions can lead to impaired glucose uptake processes (glucose intolerance), for example, diseases such as diabetes mellitus or conditions in which stress metabolism is observed, leading to a decrease in glucose tolerance (severe complications of the surgical or postoperative period, trauma). This can lead to hyperglycemia, which, in turn, can - depending on the severity - lead to osmotic diuresis, followed by the development of hypertensive dehydration and hyperosmotic disorders up to hyperosmotic coma.

    Excessive administration of glucose, especially in conditions accompanied by reduced glucose tolerance, can lead to a serious impairment of glucose uptake and, due to the restriction of oxidative glucose uptake, to a greater transition of glucose to fat. This, in turn, may be accompanied by higher levels of CO2 in the body (problems associated with turning off the ventilator), as well as increased fat infiltration into tissues, especially the liver. Patients with traumatic brain injury or cerebral edema are especially at risk of impaired glucose homeostasis. In these cases, even slight disturbances in the concentration of glucose in the blood and, consequently, an increase in plasma (serum) osmolarity can lead to a marked increase in brain disorders.

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

    Pharmacokinetics

    During infusion, glucose first enters the intravascular space, followed by movement into the extracellular space. During glycolysis, glucose is converted to pyruvate or lactate. Further, lactate is partially 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 (H2O). Normally, glucose is not eliminated by the kidneys. In pathological conditions (such as diabetes mellitus, decreased glucose tolerance) with hyperglycemia (blood glucose concentration greater than 120 mg/ml or 6.7 mmol/l), glucose is excreted by the kidneys (glucosuria) when the maximum glomerular filtration rate (180 mg/100 ml) is exceeded or 10 mmol/l).

    Use during pregnancy

    There are no clear contraindications. However, use during pregnancy and lactation when the benefit to the mother outweighs the potential risk to the fetus or newborn.

    Contraindications for use

    Hyperhydration;

    Hypotonic dehydration;

    Hyperkalemia.

    With caution: with hyponatremia, renal failure with a tendency to hyperkalemia, hyperglycemia not stopped by insulin at a dose of up to 6 units / h.

    Side effects

    Dosage and administration

    For intravenous administration (central or peripheral access).

    The dose is selected individually in accordance with the patient's needs for fluid and electrolytes.

    Maximum daily dose: up to 40 ml / kg body weight / day, respectively 2.0 g glucose / kg body weight / day, 4 mmol sodium / kg body weight / day and 0.7 mmol calcium / kg body weight / day.

    Injection rate: up to 5 ml/kg body weight/hour, respectively 0.25 g glucose/kg body weight/hour. The rate of administration is 1.6 drops / kg of body weight / min.

    Duration of use:

    The solution can be used within a few days. The duration of use is determined by the clinical condition of the patient and laboratory parameters.

    With normal metabolism, the total amount of carbohydrates administered should not exceed 350-400 g / day. With the introduction of such doses, glucose is completely oxidized. The appointment of higher doses can cause the development of side effects and lead to fatty infiltration of the liver. In conditions of impaired metabolism, for example, after major operations or injuries, 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 dose restrictions for adults must be strictly observed: 0.25 g glucose / kg body weight / hour and up to 6 g / kg body weight / day. The appointment of solutions containing carbohydrates - regardless of the 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. The use of infusion pumps is recommended to prevent carbohydrate overdose, especially when using solutions with a high concentration of carbohydrates.

    The level of 30 ml of solution/kg of body weight/day covers only the physiological needs of the body for fluid. In postoperative and resuscitated patients, fluid requirements are increased due to reduced renal concentrating function and increased excretion of metabolic products, resulting in the need to increase fluid intake to approximately 40 ml/kg body weight/day. Additional losses (fever, diarrhoea, fistulas, vomiting, etc.) must be compensated for by even higher fluid administration, the level of which is set individually. The actual individual level of fluid requirement is determined by consistent monitoring of clinical and laboratory parameters (urine excretion, serum and urine osmolarity, determination of excreted substances).

    The main substitution of the most important sodium and potassium cations reaches 1.5-3 mmol per kg/body weight/day and 0.8-1.0 mmol/kg body weight/day, respectively. The actual requirements for infusion therapy are determined by electrolyte balance and monitoring of plasma electrolyte concentrations.

    Overdose

    Symptoms: an overdose of the drug can lead to such phenomena as hyperhydration with an increase in skin turgor, venous congestion and the development of general edema, followed by the development of pulmonary edema.

    Treatment: immediately stop the infusion, prescribe diuretics with constant monitoring of plasma electrolytes; correction of electrolyte balance.

    Glucose overdose

    Symptoms: hyperglycemia, glucosuria, dehydration, serum hyperosmolarity, hyperglycemic or hyperosmolar coma.

    Treatment: the infusion should be stopped immediately; carrying out rehydration; the appointment of insulin with constant monitoring of blood glucose; replacement of electrolyte losses, monitoring of acid-base balance.

    Interactions with other drugs

    Suxamethonium and potassium, when co-administered, can have a negative effect on heart rate due to severe hyperkalemia.

    Special instructions for admission

    Clinical monitoring should include monitoring of serum electrolytes and fluid balance.

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

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

    The solution should not be administered through the same transfusion systems, simultaneously, before or after blood administration due to the risk of pseudo-agglutination.

    Only a solution containing 70 mmol/l sodium can be used to treat hypertensive dehydration. Correction of dehydration should be carried out for at least 48 hours. The introduction of a solution for postoperative, post-traumatic or other conditions with impaired glucose tolerance must be carried out under the condition of constant monitoring of glucose concentration.

    Storage conditions

    At a temperature not exceeding 25 ° C (do not freeze).

    Best before date

    Belonging to ATX-classification:

    B Hematopoiesis and blood

    B05 Plasma substitutes and perfusion solutions

    B05B Intravenous solutions

    B05BB Solutions affecting fluid and electrolyte balance

    solution for inf.: bottle. 100 ml 20 pcs, bottle 500 ml or 1 l 10 pcs. Reg. No.: LS-000969

    Clinico-pharmacological group:

    Preparation for rehydration and detoxification for parenteral use

    Release form, composition and packaging

    500 ml - plastic containers "Viaflex" (1) - plastic bags.
    1 l - plastic containers "Viaflex" (1) - plastic bags.
    500 ml - plastic containers (1) - plastic bags.
    500 ml - plastic containers (1) - plastic bags (20) - cardboard boxes.
    1 l - plastic containers "Viaflex" (1) - plastic bags (10) - cardboard boxes.

    Description of the active ingredients of the drug Normofundin g-5»

    pharmachologic effect

    The drug is an electrolyte solution with a total amount of cations equal to 123 mmol/l, whose composition was selected based on the need to compensate for violations of the mineral composition of the body during metabolic stress. To this end, in comparison with electrolyte solutions close to plasma in composition, the amount of sodium is reduced in order to prevent the retention of sodium and liquid.

    Sufficiently high concentration of potassium in comparison with electrolyte solutions close to plasma reflects the increased need of the body for potassium in stressful situations, with adequate replacement of fluids, which is approximately 1 mmol/kg of body weight/day.

    Acetate oxidizes and has an alkalizing effect. The composition of anions is represented by a balanced combination of chlorides, which are not metabolized, and acetates, which are metabolized and prevent the development of metabolic acidosis.

    In addition, the solution contains carbohydrates in the form of a 5% glucose solution. From a physiological point of view, glucose is the primary energy source with a caloric value of about 16 kJ or 3.75 kcal/g. Providing the body with glucose is necessary for the functioning of the tissues of the nervous system, red blood cells, and the medulla of the kidneys.

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

    There is a close relationship between electrolytes and carbohydrate metabolism.

    Glucose uptake and an increased need for potassium are linked. If this is not taken into account, then this can lead to a violation of potassium metabolism, which, in turn, can cause severe heart rhythm disturbances.

    Some pathological conditions can lead to impaired glucose uptake processes (glucose intolerance), for example, diseases such as diabetes mellitus or conditions in which stress metabolism is observed, leading to a decrease in glucose tolerance (severe complications of the surgical or postoperative period, trauma). This can lead to hyperglycemia, which, in turn, can - depending on the severity - lead to osmotic diuresis, followed by the development of hypertensive dehydration and hyperosmotic disorders up to hyperosmotic coma.

    Excessive administration of glucose, especially in conditions accompanied by reduced glucose tolerance, can lead to a serious impairment of glucose uptake and, due to the restriction of oxidative glucose uptake, to a greater transition of glucose to fat. This, in turn, may be accompanied by higher levels of CO 2 in the body (problems associated with turning off the ventilator), as well as increased fat infiltration into tissues, especially the liver. Patients with traumatic brain injury or cerebral edema are especially at risk of impaired glucose homeostasis. In these cases, even slight disturbances in the concentration of glucose in the blood and, consequently, an increase in plasma (serum) osmolarity can lead to a marked increase in brain disorders.

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

    Indications

    - hypertensive dehydration;

    - isotonic dehydration;

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

    - for dilution of concentrated solutions of electrolytes and medicines.

    Dosing regimen

    For intravenous administration (central or peripheral access).

    The dose is selected individually in accordance with the patient's needs for fluid and electrolytes.

    Maximum daily dose: up to 40 ml / kg body weight / day, respectively 2.0 g glucose / kg body weight / day, 4 mmol sodium / kg body weight / day and 0.7 mmol calcium / kg body weight / day.

    Injection rate: up to 5 ml/kg body weight/hour, respectively 0.25 g glucose/kg body weight/hour. The rate of administration is 1.6 drops / kg of body weight / min.

    Duration of use:

    The solution can be used within a few days. The duration of use is determined by the clinical condition of the patient and laboratory parameters.

    With normal metabolism, the total amount of carbohydrates administered should not exceed 350-400 g / day. With the introduction of such doses, glucose is completely oxidized. The appointment of higher doses can cause the development of side effects and lead to fatty infiltration of the liver. In conditions of impaired metabolism, for example, after major operations or injuries, 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 dose restrictions for adults must be strictly observed: 0.25 g glucose / kg body weight / hour and up to 6 g / kg body weight / day. The appointment of solutions containing carbohydrates - regardless of the 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. The use of infusion pumps is recommended to prevent carbohydrate overdose, especially when using solutions with a high concentration of carbohydrates.

    The level of 30 ml of solution/kg of body weight/day covers only the physiological needs of the body for fluid. In postoperative and resuscitated patients, fluid requirements are increased due to reduced renal concentrating function and increased excretion of metabolic products, resulting in the need to increase fluid intake to approximately 40 ml/kg body weight/day. Additional losses (fever, diarrhoea, fistulas, vomiting, etc.) must be compensated for by even higher fluid administration, the level of which is set individually. The actual individual level of fluid requirement is determined by consistent monitoring of clinical and laboratory parameters (urine excretion, serum and urine osmolarity, determination of excreted substances).

    The main substitution of the most important sodium and potassium cations reaches 1.5-3 mmol per kg/body weight/day and 0.8-1.0 mmol/kg body weight/day, respectively. The actual requirements for infusion therapy are determined by electrolyte balance and monitoring of plasma electrolyte concentrations.

    Side effect

    Contraindications

    - hyperhydration;

    - hypotonic dehydration;

    - hyperkalemia.

    WITH caution: with hyponatremia, renal failure with a tendency to hyperkalemia, hyperglycemia not stopped by insulin at a dose of up to 6 units / h.

    Pregnancy and lactation

    There are no clear contraindications. However, use during pregnancy and lactation when the benefit to the mother outweighs the potential risk to the fetus or newborn.

    Application for violations of kidney function

    Use with caution in renal failure with a tendency to hyperkalemia.

    Use in the elderly

    special instructions

    Clinical monitoring should include monitoring of serum electrolytes and fluid balance.

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

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

    The solution should not be administered through the same transfusion systems, simultaneously, before or after blood administration due to the risk of pseudo-agglutination.

    Only a solution containing 70 mmol/l sodium can be used to treat hypertensive dehydration. Correction of dehydration should be carried out for at least 48 hours. The introduction of a solution for postoperative, post-traumatic or other conditions with impaired glucose tolerance must be carried out under the condition of constant monitoring of glucose concentration.

    Overdose

    Symptoms: an overdose of the drug can lead to such phenomena as hyperhydration with an increase in skin turgor, venous congestion and the development of general edema, followed by the development of pulmonary edema.

    Treatment: with it is necessary to immediately stop the infusion, prescribe diuretics with constant monitoring of plasma electrolytes; correction of electrolyte balance.

    Overdose glucose

    Symptoms: hyperglycemia, glucosuria, dehydration, serum hyperosmolarity, hyperglycemic or hyperosmolar coma.

    Treatment: the infusion should be stopped immediately; carrying out rehydration; the appointment of insulin with constant monitoring of blood glucose; replacement of electrolyte losses, monitoring of acid-base balance.

    drug interaction

    Terms of dispensing from pharmacies

    For use in hospitals.

    Terms and conditions of storage

    Store the drug at a temperature not exceeding 25 ° C, out of the reach of children. Shelf life - 3 years. Do not use after the expiry date stated on the packaging.

    drug interaction

    Suxamethonium and potassium, when co-administered, can have a negative effect on heart rate due to severe hyperkalemia.



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