potassium chloride, calcium chloride, magnesium chloride, sodium acetate, sodium chloride, malic acid | Sterofundin isotonic infusion solution 500 ml plastic bottle 10 pcs.

Pharmacological action

Isotonic sterofundin is an isotonic electrolyte solution with an electrolyte concentration adapted to the concentration of blood plasma electrolytes. It is used to correct extracellular fluid loss (i.e., loss of proportional amounts of water and electrolytes). The introduction of the solution is aimed at restoring and maintaining the osmotic status in the extracellular and intracellular space.

Anionic composition is represented by a balanced combination of chlorides, acetates and malates, which is close in molar concentration to the anionic composition of blood plasma, which contributes to the correction of metabolic acidosis.

Pharmacokinetics:

Since Sterofundin is isotonic is administered intravenously, the bioavailability of all its components is 100%.

Sodium and chloride are mainly distributed in the extracellular space, while 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 quantities through the skin and gastrointestinal tract. Calcium is excreted in approximately equal amounts with urine and endogenous intestinal secretion.

During the infusion of acetates and malates, their concentration in the blood plasma increases to a constant value. Then, after the cessation of infusion, their concentration drops sharply. The excretion of acetates and malates with urine during infusion increases. However, the metabolism of these substances in the tissues of the body proceeds so quickly that only a small amount of them enter the urine.

Acetates are metabolized in the liver, heart and other tissues under the influence of acetyl coenzyme A (acetyl-CoA) -synthetase. The resulting acetyl-CoA is then metabolized in the measles cycle reactions and is ultimately converted to carbon dioxide and water.

Malates are metabolized in the Krebs cycle under the influence of malate dehydrogenase, which catalyzes the conversion of malate to oxaloacetate.

Indications

Substitution of extracellular fluid loss during isotonic dehydration in patients with acidosis or the threat of its development.

Contraindications

- Hypervolemia

- chronic heart failure III-IV functional class

- renal failure with oliguria or anuria

- severe general edema

- hyperkalemia

- hypercalcium

Precautions:

High volume infusion in patients with heart or pulmonary insufficiency should be performed with continuous monitoring.

Solutions containing sodium chloride should be prescribed with caution to patients with:

- mild or moderate heart failure, peripheral edema or pulmonary edema, or extracellular hyperhydration,

- hypernatremia, hyperchloremia, hypertonic dehydration, arterial hypertension, impaired renal function, eclampsia or the threat of its occurrence, aldestorism and other conditions and treatment methods (e.g., corticosteroids) associated with sodium retention.

Solutions containing potassium salts should be prescribed with caution to patients with heart disease or a predisposition to hyperkalemia in renal failure or adrenal cortex insufficiency, acute dehydration or extensive tissue destruction, which occurs with severe burns.

Due to the presence of calcium:

- it is necessary to exclude the possibility of extravasal penetration of the solution during intravenous infusion,

- the solution should be administered with caution to patients with impaired renal function or disease, accompanied by an increase in the concentration of vitamin D, such as sarcoidosis,

- after a blood transfusion, the solution should not be administered using the same infusion system.

Solutions containing metabolizable anions should be administered with caution to patients with respiratory problems.

Monitoring of serum electrolytes, body fluid balance and blood pH is necessary.

Isotonic sterofundin should be used with caution in pregnant women with toxicosis.

Use during pregnancy and lactation

Data on the use of the drug Sterofundin isotonic during pregnancy and during breastfeeding are limited.

With constant monitoring of the volume of infusion, the concentration of electrolytes and the acid-base balance, there are no complications when using the drug if indicated.

Special instructions

The solution has a pH of 5.1-5.9 and a theoretical osmolarity of 309 mOsm / L. Therefore, it can be injected into peripheral veins.

If the administration is by rapid infusion under pressure, all air must be removed from the polyethylene bottle and infusion system before starting the infusion, as otherwise there is a risk of air embolism.

Water-electrolyte balance and acid-base state during infusion should be constantly monitored.

Unused solution must be disposed of.

Use only a clear solution that is practically free of mechanical impurities.

Solution administration should be aseptic.

Do not freeze!

Impact on the ability to drive transp. Wed and fur .:

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

Composition

100 ml the solution contains:

Active ingredients:

Sodium chloride

6.80 g

Potassium chloride

0.30 g

Calcium chloride dihydrate

0, 37 g

Magnesium chloride hexahydrate

0.20 g

Sodium acetate trihydrate

3.27 g

Malic acid

0.67 g

Excipients:

Sodium hydroxide

0.20 g srdlp concentration srdlp 1000 crdl srdlp electrolytes:

Sodium

145.0 mmol / L

Potassium

4.0 mmol / L

Calcium

2.5 mmol / L

Magnesium

1.0 mmol / L

Chlorides

127.0 mmol / L srdlp 24.0 mmol / L

Malates

5.0 mmol / L

Physical and chemical characteristics:

Theoretical osmolarity

309 mOsm / L

pH

5.1 to 5.9

Dosage and Administration

Isotonic sterofundin is injected drip into the peripheral and central veins.

Dose depends on the age, body weight, clinical and biological condition of the patient, and concomitant therapy.

Recommended doses of

- for elderly, adults and children from 11 years of age, from 500 ml to 3 l / day, which corresponds to 1-6 mmol of sodium / kg body weight / day and 0.03-0.17 mmol of potassium / kg body weight /

day - for children under 11 years old from 20 ml to 100 ml / kg body weight / day, which corresponds to 3-14 mmol of sodium / kg body weight / day and 0.08-0.40 potassium / kg body weight / day.

Speed ​​of administration

The maximum speed of administration is determined by the patient's needs for fluid and electrolytes, body weight, clinical condition and biological status of the patient.

For children, the average administration rate is 5 ml / kg body weight / h, but it depends on age:

- for children under 1 year 6-8 ml / kg body weight / h

- for children from 1 year to 2 years 4-6 ml / kg body weight / h

- for children from 2 to 11 years old 2-4 ml / kg body weight / h.

Duration of use of

Isotonic sterofundin can be administered as long as required to restore the water-electrolyte balance.

General recommendations for the use of fluids and electrolyte solutions

A dose of 30 ml of solution / kg body weight / day covers only the physiological needs of the body for fluids. In patients undergoing surgery, and patients in critical conditions, fluid requirements increase due to decreased concentration function of the kidneys 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, fistulas, vomiting, etc.) must be compensated by an even higher injection of fluid, the level of which is set individually. The actual individual level of fluid demand is determined by consistent monitoring of clinical and laboratory parameters (urine output, serum and urine osmolarity, determination of excreted substances).

The main substitution 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. Actual needs for infusion therapy are determined by the state of water-electrolyte balance.

Drug Interactions

In order to avoid precipitation, isotonic Sterofundin should not be mixed with preparations containing carbonates, phosphates, sulfates or tartrates.

Sodium, potassium, calcium and magnesium are contained in the preparation Sterofundin isotonic in the same concentrations as in blood plasma. Therefore, the use of Sterofundin isotonic in accordance with the indications and contraindications does not lead to an increase in the concentrations of these electrolytes.

In the case of an increase in the concentration of any of the electrolytes for other reasons, the following interactions should be taken into account.

Interactions with sodium:

- corticosteroids and carbenoxolone have the ability to retain sodium and water (with the occurrence of edema and hypertension).

Interactions with potassium:

- suxamethonium,

- potassium-sparing diuretics (amiloride, spironolactone, triamteren),

- tacrolimus, cyclosporine

can increase the concentration of potassium in blood plasma, which leads to a potentially dangerous hypercalia.

Interactions with Calcium:

- with hypercalcemia, the effect of cardiac glycosides may increase, which can lead to severe cardiac arrhythmias with a possible fatal outcome.

Vitamin D may cause hypercalcemia.

Overdose

Volume overload and overdose of electrolytes:

Symptoms

Overdosing can lead to symptoms such as hypertensive hyperhydration, electrolyte disturbances, pulmonary edema.

Treatment

Immediate cessation of infusion, the appointment of diuretics with constant monitoring of the concentration of electrolytes in blood plasma correction of electrolyte balance.

Storage conditions

Store at 2 to 25 РC.

Keep out of the reach of children.

The Expiration of

is 3 years.