Sterofundin ISO (sodium chloride) for infusions 500 ml. №10

$54.00

Substitution of intercellular fluid loss in the case of isotonic dehydration in the presence or risk of acidosis.

Category:

Description

Storage
active substances: sodium chloride; potassium chloride; magnesium chloride, hexahydrate; calcium chloride, dihydrate; sodium acetate, trihydrate; L-malonic acid;
500 ml of solution contain 6.80 g of sodium chloride; 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;
electrolyte concentration: sodium – 145 mmol / l; potassium – 4 mmol / l; magnesium – 1 mmol / l; calcium – 2.5 mmol / l; chlorides – 127 mmol / l; acetates – 24 mmol / l; malate – 5 mmol / l;
Excipients: water for injections, sodium hydroxide.
Dosage form
Solution for infusion.
Basic physical and chemical properties: transparent colorless solution, practically free of mechanical particles. Theoretical osmolarity 309 mOsm / l; pH 5.1 – 5.9.
Pharmacological properties
This drug is an isotonic electrolyte solution in which the electrolyte concentrations correspond to their plasma concentrations. It is used to correct the loss of extracellular fluid (ie loss of water and electrolytes in proportion). The purpose of the solution is to restore and maintain normal osmotic conditions in the extracellular and intracellular space.
The anionic composition of the drug is a balanced combination of chlorides, acetates and malates, which prevents the occurrence of metabolic acidosis.
Indication
Replacement of intercellular fluid loss in the case of isotonic dehydration in the presence or threat of acidosis.
Contraindication
Hypersensitivity to any active substance or excipient that is part of the drug.

  • Hyperhydration.
  • Severe congestive heart failure.
  • Renal failure with oliguria or anuria.
  • Severe general edema.
  • Severe hyperkalemia.
  • Hypercalcemia.
  • Metabolic alkalosis.
  • Severe metabolic acidosis.

Use during pregnancy or breastfeeding
There are no data from the use of Sterofundin ISO in pregnant and lactating women. Within the recommended indications, no risk should be expected if the volume of solution administered, electrolyte levels and acid-base levels are carefully monitored.
Sterofundin ISO should be used with caution in toxicosis of pregnant women.
Ability to influence the speed of reaction when driving a car or working with other mechanisms
Sterofundin ISO is not affected or has little effect on the ability to drive or use machines.
Method of application and dosage
The dose should be determined depending on the actual need to replenish water and electrolytes.
Adults
The maximum daily dose
The volume of solution administered should not exceed 40 ml / kg body weight per day (corresponding to 5.8 mmol sodium per 1 kg body weight and 0.16 mmol potassium per 1 kg body weight).
Additional fluid loss (such as fever, diarrhea, vomiting, etc.) should be compensated for depending on the volume and composition of 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 patient’s clinical condition.
In the treatment of acute fluid deficiency, namely severe or life-threatening hypovolemic shock, higher doses may be used, for example, by rapid infusion (under pressure).
Maximum infusion rate
The infusion rate of the drug should not exceed 100 ml / h.
In the treatment of dehydration, the maximum infusion rate is 5 ml / kg body weight per hour, which corresponds to 0.7 mmol sodium per 1 kg body weight per hour and 20 micromoles potassium per 1 kg body weight per hour.
For short-term intravascular replenishment, the maximum infusion rate depends on the patient’s clinical situation.
In life-threatening situations, you can quickly enter 500 ml of the drug under manual pressure.

Solvent

When using Sterofundin ISO as a solvent, the dosage and infusion rate are determined mainly on the basis of the characteristics and dosage regimen of the solute.

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

Such daily doses should not be exceeded.
Age-dependent dose (ml / kg body weight per day):

  • from 28 days of life 160;
  • from 2 months 150;
  • 1-2 years 120;
  • 3-5 years 100;
  • 6–12 years 80;
  • 13-18 years 70.

Additional fluid loss (such as fever, diarrhea, vomiting, etc.) should be compensated for depending on the volume and composition of fluid lost.
In case of dehydration or short-term replenishment of intravascular volume, the above doses can be increased.
The dose should be calculated taking into account the severity of dehydration and the patient’s clinical condition.
Elderly patients
Generally, the same doses are used as for adults, but attention should be paid to patients with diseases such as heart failure or renal failure, which may be associated with old age.
Patients with chronic hyponatremia
To prevent the development of osmotic demyelinating syndrome, the increase in serum sodium should not exceed 9 mmol / l / day. As a general recommendation, dose adjustment should be 4 to 6 mmol / l / day for most cases, depending on the patient’s condition and associated risk factors.
Method of administration
For intravenous infusion only.
Sterofundin ISO can be injected into peripheral veins (for pH and theoretical osmolarity, see section “Basic physicochemical properties”).
When administering by rapid infusion under pressure from the plastic container and the delivery system, all air must be removed before infusion, as otherwise there is a risk of air embolism during infusion.
At introduction it is necessary to carry out monitoring of liquid balance, plasma concentration of electrolytes and pH.
ISO sterofundin can be administered as long as there are indications for fluid replacement.
Children
The drug can be used in children over 28 days of age according to the indications.
Overdose
Excessive or too rapid administration of the solution can lead to water or sodium overload with increased skin turgor, venous stasis and the development of edema, especially in the case of impaired excretion of sodium by the kidneys. In this case, additional hemodialysis may be required.
Excess potassium can lead to the development of hyperkalemia, especially in patients with renal insufficiency. Symptoms include limb paresthesia, muscle weakness, paralysis, cardiac arrhythmia, heart block, cardiac arrest, and confusion. Treatment of hyperkalemia includes the use of calcium, insulin (with glucose), sodium bicarbonate, metabolic resins or dialysis.
Excessive parenteral administration of magnesium salts leads to the development of hypermagnesemia, important signs of which are the loss of the deep tendon reflex and respiratory depression, both manifestations of which occur due to neuromuscular blockade. Other symptoms of hypermagnesemia may include nausea, vomiting, redness of the skin, thirst, hypotension due to dilation of peripheral blood vessels, dizziness, confusion, muscle weakness, bradycardia, coma, and cardiac arrest.
Excessive introduction of chlorides can cause loss of bicarbonate with the manifestation of acidosis.
Excessive use of compounds metabolized to the bicarbonate anion, such as acetates and malate, can lead to metabolic alkalosis, especially in patients with renal impairment. Symptoms may include mood swings, fatigue, shortness of breath, muscle weakness, and cardiac arrhythmias (arrhythmias). Patients with additional hypocalcaemia may develop muscle hypertonia, muscle contractions, and cramps. Treatment of metabolic alkalosis, associated with an increase in bicarbonate levels, consists mainly in the appropriate correction of fluid and electrolyte balance.
Excessive intake of calcium salts can lead to hypercalcemia. Symptoms of hypercalcemia may include anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disorders, polydipsia, polyuria, nephrocalcinosis, kidney stones, and in severe cases, cardiac arrhythmia and coma. Very rapid intravenous administration of calcium salts can also cause numerous symptoms of hypercalcemia, as well as the appearance of a taste of chalk in the mouth, hot flashes and dilation of peripheral blood vessels. Mild asymptomatic hypercalcaemia usually occurs after discontinuation of calcium and other drugs that promote its development, such as vitamin D. In case of severe hypercalcemia, urgent treatment is required (eg, use of loop diuretics, hemodialysis, calcitonin, bisphosphonates, edetate trisodium).

If an overdose is associated with medications added to the solution, the signs and symptoms of overdose will also be related to the nature of the added substances. In the event of an accidental overdose, treatment should be discontinued and the patient should be examined for signs and symptoms associated with the drug. If necessary, appropriate symptomatic and supportive measures should be taken.
Treatment.
Stop the infusion immediately. Further treatment depends on the nature and severity of symptoms and may include the introduction of diuretics with frequent monitoring of electrolyte balance, correction of electrolyte and acid-base imbalance.
Treatment of hyperkalemia includes the use of calcium, insulin (with glucose), sodium bicarbonate, metabolic resins or dialysis.
Side effects
Signs of overdose may occur.
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 following intravenous administration of magnesium sulfate.
Adverse reactions may be associated with the technique of administration, including febrile response, injection site infections, local pain or local reactions, venous irritation, venous thrombosis or phlebitis spreading from the injection site, and extravasation. Adverse reactions may also be associated with medications added to the solution, the nature of the added substances will determine the type of any other side effects.
Expiration date
Shelf life during storage in plastic containers – 3 years, in plastic bags – 2 years.
Shelf life after first 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 the drug is responsible for its proper storage until the next use, which should not normally exceed 24 hours at 2-8 ° C, if the solution has not been reconstituted under controlled and confirmed aseptic conditions. dilute.
Storage conditions
Keep out of reach of children at a temperature not exceeding 25 ° C. Do not freeze.