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

Description

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

Composition

active substances: sodium chloride; potassium chloride; magnesium chloride, hexahydrate; calcium chloride, dihydrate; sodium acetate, trihydrate; L-malonic acid;

1000 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 infusions.

Basic physical and chemical properties: transparent colorless solution, practically free of mechanical particles. Theoretical osmolarity 309 mOsm / l; pH 5.1 – 5.9.

Pharmacotherapeutic group

Blood substitutes and perfusion solutions. Solutions for intravenous administration. Solutions used to correct electrolyte imbalance. Electrolytes.
ATX code B05B B01.

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 solution should be used with caution in toxicosis of pregnant women.

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 Sterofundin ISO 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 clinical condition of the patient.

In the treatment of acute fluid deficiency, namely severe or life-threatening hypovolemic shock, the use of higher doses is allowed, 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.

In the case of 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 solution 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.

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

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 may be increased.

The dose should be calculated taking into account the severity of dehydration and the clinical condition of the patient.

In the treatment of dehydration, the maximum infusion rate is 5 ml / kg body weight / h, 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.

Method of administration

For intravenous infusion only.

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

When administering by rapid infusion under pressure from a plastic container and 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.

Sterofundin ISO solution 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 may lead to water or sodium overload with increased skin turgor, venous congestion 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 may lead to hyperkalaemia, 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 (glucose), sodium bicarbonate, metabolic resins or dialysis.

Excessive parenteral administration of magnesium salts leads to the development of hypermagnesemia, important signs of which are loss of deep tendon reflex and respiratory depression, both manifestations of which are 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 convulsions. Treatment of metabolic alkalosis associated with increased bicarbonate levels consists mainly in the appropriate correction of fluid and electrolyte balance.

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 related to the drugs added to the solution, the nature of the substances added will determine the type of any other side effects.