Sterofundin

Sterofundin ISO infusion solution is used to replace intercellular fluid loss in the event of isotonic dehydration in the presence or threat of acidosis.

Structure

1000 ml of solution contain (active substances):

• sodium chloride - 6.80 g;
• potassium chloride - 0.30 g;
• magnesium chloride hexahydrate - 0.20 g;
• calcium chloride dihydrate - 0.37 g;
• sodium acetate trihydrate - 3.27 g;
• L-malonic acid - 0.67 g.

The concentration of electrolytes (mmol / l): sodium - 145; potassium - 4; magnesium - 1; calcium - 2.5; chlorides - 127; acetates - 24; malates - 5.

Excipients: water for injection, sodium hydroxide.

Contraindications

• hypersensitivity to any active or auxiliary substance that is part of the drug;
• overhydration;
• severe congestive heart failure;
• renal failure with oliguria or anuria;
• severe general edema;
• severe hyperkalemia;
• hypercalcemia;
• metabolic alkalosis;
• severe metabolic acidosis.

Mode of application

The dose should be determined depending on the real need to replenish the level of water and electrolytes.

Adults

The maximum daily dose. The volume of the injected solution should not exceed 40 ml / kg body weight per day (which corresponds to 5.8 mmol of sodium per kg of body weight and 0.16 mmol of potassium per kg of body weight). Additional fluid loss (for example, due to fever, diarrhea, vomiting, etc.) should be compensated for depending on the volume and composition of the fluid lost. In case of dehydration, the dose of 40 ml / kg of body weight per day may be exceeded. The dose should be calculated taking into account the severity of dehydration and the clinical condition of the patient. In the treatment of acute fluid deficiency, namely, severe or life-threatening, hypovolemic shock, the use of high doses is allowed, for example, by rapid infusion (under pressure).

Maximum infusion rate. The infusion rate of the drug should not exceed 100 ml / hour. In the treatment of dehydration, the maximum infusion rate is 5 ml / kg body weight per hour, which corresponds to 0.7 mmol of sodium per kg of body weight per hour and 20 μmol of potassium per kg of body weight per hour. With short-term replenishment of intravascular volume, the maximum infusion rate depends on the clinical situation of the patient. In life-threatening situations, you can quickly inject 500 ml of the drug under manual pressure.

Solvent. When using Sterofundin ISO infusion solution as a dosing solvent, the rate of infusion is determined mainly on the basis of the characteristics and dosage regimen of the soluble agent.

Pediatric population. The dose is prescribed by a doctor. The dose depends on the age, body weight, laboratory parameters, clinical condition and concomitant therapy of the patient.

The maximum daily dose. The following daily doses should not be exceeded:

• at the age of 28 days of life - 160 ml / kg body weight per day;
• from 2 months - 150 ml / kg of body weight per day;
• 1-2 years - 120 ml / kg body weight per day;
• 3-5 years - 100 ml / kg of body weight per day;
• 6-12 years old - 80 ml / kg body weight per day;
• 13-18 years old - 70 ml / kg body weight per day.

Additional fluid loss (for example, due to fever, diarrhea, vomiting, etc.) should be compensated for depending on the volume and composition of the fluid lost. In the case of dehydration or with short-term replenishment of the intravascular volume, the above doses can be increased. The dose should be calculated taking into account the severity of dehydration and the clinical condition of the patient.

Maximum infusion rate (body weight):

• 0-10 kg - 4 ml / kg / hour;
• 10-20 kg - 40 ml / hour + 2 ml / kg / hour above 10 kg;
• > 20 kg - 60 ml / hour + 1 ml / kg / hour above 20 kg.

In the treatment of dehydration, the maximum infusion rate is 5 ml / kg / hour, which corresponds to 0.7 mmol of sodium per kg of body weight per hour and 20 μmol of potassium per kg of body weight per hour.

Elderly patients

Basically, the same doses are used as for adults, but you should pay attention to patients with diseases such as heart failure or kidney failure, which may be associated with old age.

Chronic hyponatremia patients

To prevent the development of the osmotic demyelinating syndrome, an increase in the level of sodium in the blood serum should not exceed 9 mmol / l / day. As a general recommendation, dose adjustment should be from 4 to 6 mmol / l / day for most cases, depending on the patients condition and associated risk factors.

Route of administration

For administration by infusion only.

Sterofundin ISO can be injected into peripheral veins (pH and theoretical osmolarity).

When administered by rapid infusion under pressure from a plastic container and the administration system, all air must be removed prior to infusion, since otherwise there is a risk of air embolism during the infusion.

With the introduction, it is necessary to monitor the liquid balance, the plasma concentration of electrolytes and pH.

Sterofundin ISO can be administered as long as indications exist for fluid replacement.

Application features

Pregnant women

There are no data on the use of Sterofundin ISO infusion solution for pregnant or breastfeeding women. Within the recommended indications, one should not expect any risk if the volume of the injected solution, the level of electrolytes and acid-base indicators are carefully monitored.

Sterofundin ISO should be used with caution in pregnant women with toxicosis.

Children

The drug can be used for children aged 28 days according to indications.

Drivers

Sterofundin ISO infusion solution does not affect or has a slight effect on the ability to drive a car or work with other mechanisms.

Overdose

Excessive or too rapid administration of the solution can lead to water or sodium overload with increased skin turgor, venous stasis and with the development of edema, especially in cases of impaired excretion of sodium by the kidneys. In this case, additional hemodialysis may be required.

Treatment

Stop infusion immediately. Further treatment depends on the nature and severity of the symptoms and may include the introduction of diuretics with frequent monitoring of electrolyte balance, correction of electrolyte and acid-base imbalances. Treatment for hyperkalemia involves the use of calcium, insulin (with glucose), sodium bicarbonate, metabolic resins, or dialysis.

Side effects

Overdose signs may appear.

Hypersensitivity reactions, including urticaria.

Hyperhydration, pulmonary edema, electrolyte disorders are possible.

Although oral administration of magnesium salts stimulates peristalsis, paralytic intestinal obstruction has been reported in rare cases after magnesium sulfate administration.

Adverse reactions may be related to the administration technique, including febrile response, infections at the injection site, local pain or local reactions, vein irritation, venous thrombosis or phlebitis spreading from the injection site, and extravasation. Adverse reactions can also be associated with drugs applied to the solution, the nature of the added substances will determine the type of any other undesirable effects.

Storage conditions

Keep out of reach of children at a temperature not exceeding 25 ° C. Do not freeze.

Shelf life in plastic containers is 3 years, in plastic bags - 2 years.

Shelf life after opening the container. From a microbiological point of view, the drug should be used immediately after opening. If the solution is not administered immediately, the person using this drug is responsible for its proper storage until the next use, usually it should not exceed 24 hours at a temperature of 2-8 ° C, if the solution was not reconstituted / diluted under controlled and confirmed aseptic conditions.