Sterofundin isotonic solution for infusion 1000ml vial KP-2, 10pcs

Composition

>of 00 ml of the solution contains:

Pharmacological action

Sterofundin isotonic is an isotonic solution of electrolytes with an electrolyte concentration adapted to the concentration of blood plasma electrolytes. It is used to correct the loss of extracellular fluid (i. e., loss of water and electrolytes in proportionate amounts). The use of the solution is aimed at restoring and maintaining the osmotic status in the extracellular and intracellular space. The anionic composition is represented by a balanced combination of chlorides, acetates and malates, close in molar concentration to the anionic composition of blood plasma, which contributes to the correction of metabolic acidosis. Pharmacokinetics: Since Sterofundin isotonic is administered intravenously, the bioavailability of all its components is 100%. Sodium and chlorides 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, but also in small amounts through the skin and gastrointestinal tract. Calcium is excreted in approximately equal amounts in the 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 stopping the infusion, their concentration drops sharply. Urinary excretion of acetates and malates increases during infusion. However, the metabolism of these substances in the body’s tissues proceeds so quickly that only a small amount of them enters the urine. Acetates are metabolized in the liver, heart, and other tissues by acetyl coenzyme A (acetyl-CoA) synthetase. The resulting acetyl-CoA is further metabolized in Measles cycle reactions and eventually converted to carbon dioxide and water. Malates are metabolized in the Krebs cycle by malate dehydrogenase, which catalyzes the conversion of malate to oxaloacetate.

Indications

Replacement of extracellular fluid loss during isotonic dehydration in patients with acidosis or at risk of developing it.

Contraindications

-Hypervolemia; – chronic heart failure of functional class III-IV; – renal failure with oliguria or anuria;- severe general edema; – hyperkalemia; – hypercalcemia; – metabolic alkalosis. With caution: High-volume infusion in patients with heart or pulmonary insufficiency should be performed under constant monitoring. Sodium chloride-containing solutions should be used with caution in 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 at risk of eclampsia, aldestoronism, and other conditions and treatments (for example, corticosteroids) associated with sodium retention. Solutions containing potassium salts should be administered with caution to patients with heart disease or predisposition to hyperkalemia in renal or adrenal insufficiency, acute dehydration or extensive tissue destruction, which is observed in 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 in patients with impaired renal function or diseases associated with increased vitamin D concentrations, such as sarcoidosis, – after 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 disorders. Monitoring of serum electrolytes, body fluid balance, and blood pH is necessary. Sterofundin isotonic should be used with caution in toxicosis of pregnant women.

Side effects

There are descriptions of hypersensitivity reactions in the form of urticaria after intravenous use of magnesium salts. Despite the fact that enteral use of magnesium salts stimulates peristalsis, there are isolated reports of the development of paralytic intestinal obstruction after intravenous use of magnesium sulfate. Adverse side effects may be related to the application technique and include febrile reactions, infection, pain and other reactions at the puncture site, irritation, thrombosis or phlebitis at the puncture site or extravascular penetration of the solution. Adverse side effects can be caused by drugs added to Sterofundin isotonic, the nature and probability of such reactions is determined by the nature of the drugs added.

Interaction

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. If the concentration of any of the electrolytes increases due to 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 arterial hypertension). Interactions with potassium: – suxamethonium, – potassium-sparing diuretics (amiloride, spironolactone, triamterene), – tacrolimus, cyclosporine can increase the concentration of potassium in the blood plasma, which leads to potentially dangerous hyperkalemia, especially in renal failure. Interactions with calcium: – with hypercalcemia, the effect of cardiac glycosides may increase, which can lead to severe cardiac arrhythmia with a possible fatal outcome. Vitamin D can cause hypercalcemia.

How to take it, course of use and dosage

Sterofundin isotonic is injected dropwise into the peripheral and central veins. The dose depends on the patient’s age, body weight, clinical and biological condition, and concomitant therapy. Recommended doses: 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 of body weight/day and 0.03-0.17 mmol of potassium/kg of body weight/day; – children under 11 years of age from 20 ml to 100 ml/kg of body weight/day, which corresponds to 3-14 mmol of sodium/kg of body weight/day and 0.08-0.40 potassium/kg of body weight/day. The maximum rate of use is determined by the patient’s fluid and electrolyte requirements, body weight, clinical condition, and biological status. For children, the average rate of use is 5 ml / kg of body weight / h, but it depends on age: – for children under 1 year 6-8 ml / kg of body weight / h; – for children from 1 year to 2 years 4-6 ml/kg of body weight/h; – for children from 2 to 11 years 2-4 ml/kg of body weight/h. Duration of application Sterofundin isotonic can be administered for as long as it is required to restore the water-electrolyte balance. General recommendations for the use of fluids and electrolyte solutionsdose of 30 ml of solution/kg of body weight / day covers only the physiological needs of the body in fluid.In patients who have undergone 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 of body weight/day. Additional losses (fever, diarrhea, fistulas, vomiting, etc. ) must be compensated by an even higher level of liquid, the level of which is set individually. The actual individual level of fluid demand is determined by consistent monitoring of clinical and laboratory parameters (urinary excretion, osmolarity of serum and urine, determination of secreted substances). The main substitution of the most important sodium and potassium cations is 1.5-3.0 mmol / kg of body weight / day and 0.8-1.0 mmol / kg of body weight / day, respectively. The actual requirements for infusion therapy are determined by the state of water and electrolyte balance.

Overdose

Volume overload and electrolyte overdose:Symptomsperedose of the drug can lead to such phenomena as hypertensive hyperhydration, electrolyte disturbances, and pulmonary edema. Treatment: Immediate discontinuation of the infusion, use of diuretics with constant monitoring of plasma electrolyte concentrations; correction of electrolyte balance.

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 injection is performed by rapid pressure infusion, all air must be removed from the plastic bottle and infusion system before starting the infusion, as otherwise there is a risk of air embolism. The water-electrolyte balance and acid-base state during the infusion should be constantly monitored. The unused solution must be disposed of. It is allowed to use only a clear solution that is practically free from mechanical inclusions. The introduction of the solution should be carried out in compliance with asepsis. Do not freeze!Influence on the ability to drive vehicles and mechanisms:The drug does not affect the ability to drive vehicles, mechanisms, or engage in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store at a temperature of 2 to 25 °C. Keep out of reach of children.

Shelf

life is 3 years.

Active ingredient

Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, Sodium Chloride, Malic Acid

Conditions of release from pharmacies

Prescription