Sterofundin ISO solution for infusions container 500 ml No. 10

Instructions for Sterofundin ISO solution for infusions container 500 ml No. 10

Composition

active ingredients: sodium chloride; potassium chloride; magnesium chloride, hexahydrate; calcium chloride, dihydrate; sodium acetate, trihydrate; L-malonic acid; 1000 ml of solution contains 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;

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; malates - 5 mmol/l;

Excipients: water for injection, sodium hydroxide.

Dosage form

Solution for infusion.

Main physicochemical properties: transparent colorless solution, practically free from 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 imbalances. Electrolytes. ATX code B05B B01.

Pharmacological properties

Pharmacodynamics

This drug is an isotonic electrolyte solution, in which the concentrations of electrolytes correspond to their plasma concentrations. It is used to correct extracellular fluid losses (i.e., loss of water and electrolytes in proportional amounts). 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.

Pharmacokinetics

Since Sterofundin ISO is administered intravenously, its bioavailability is 100%. Sodium and chloride are distributed mainly in the extracellular space, while potassium, magnesium and calcium are distributed mainly intracellularly. The kidneys are the main route of excretion of sodium, potassium, magnesium and chloride, although minor amounts of electrolytes are lost through the skin and the digestive tract. Calcium is excreted in the urine and by intestinal secretion in approximately equal amounts. During infusion of acetates and malates, their plasma levels increase until equilibrium levels are reached. After cessation of infusion, anion concentrations decrease rapidly. Urinary excretion of acetates and malates increases during infusion, but their metabolism in body tissues is so rapid that only minor fractions are detected in the urine.

Indication

Replacement of intercellular fluid losses in case of isotonic dehydration in the presence or threat of acidosis.

Contraindication

Hypersensitivity to any active substance or excipient included in the composition 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.

Interaction with other medicinal products and other types of interactions

Sodium, potassium, calcium and magnesium are present in Sterofundin ISO in the same concentrations as in blood plasma. Therefore, the use of Sterofundin ISO according to the recommended indications and contraindications does not lead to an increase in plasma concentrations of these electrolytes. In the event of an increase in the concentration of any electrolyte for other reasons, the following interactions should be considered.

Medications that cause sodium retention

The use of nonsteroidal anti-inflammatory drugs, corticosteroids/steroids and carbenoxolone may lead to sodium and water retention (with edema and hypertension).

Drugs that interact with potassium

Suxamethonium, ACE inhibitors, nonsteroidal anti-inflammatory drugs, potassium-sparing diuretics (amiloride, spironolactone, triamterene, alone or in combination), tacrolimus, cyclosporine may increase plasma potassium concentrations and lead to potentially fatal hyperkalemia, especially in the presence of renal failure, which increases the hyperkalemic effect and may lead to cardiac arrhythmias. Potassium administration may reduce the therapeutic effect of cardiac glycosides. ACTH, corticosteroids and loop diuretics may increase renal elimination of potassium.

Drugs that interact with calcium

The effects of digitalis glycosides (digitalis cardiotonics) in hypercalcemia may be potentiated and lead to serious or fatal cardiac arrhythmias. Thiazide diuretics and vitamin D may cause hypercalcemia. Calcium complexes render tetracycline antibiotics inactive.

Drugs that interact with malate

Alkalization of the urine after administration of a bicarbonate precursor or bicarbonate leads to an increase in the renal clearance of acid-containing drugs. The half-life of major drugs, especially sympathomimetics (e.g., ephedrine, pseudoephedrine) and stimulants (e.g., dexamfetamine sulfate, fenfluramine hydrochloride), is prolonged when malate-containing solutions are administered simultaneously.

Application features

Large volume infusions may be used in patients with mild to moderate cardiac or respiratory failure with close monitoring (for more severe conditions, see Contraindications).

Sterofundin ISO should only be administered with extreme caution and under constant monitoring to patients with conditions such as:

hypernatremia; hyperchloremia; renal failure; coma of unknown origin; concomitant treatment with digitalis drugs; hyperkalemia or conditions that may lead to hyperkalemia, including Addison's disease, sickle cell anemia;

hypertensive dehydration, arterial hypertension, impaired renal function, existing or threatened eclampsia, aldosteronism or other conditions or with simultaneous treatment with drugs (e.g. corticosteroids/steroids) associated with sodium retention and drugs that increase serum potassium levels (see also section "Interaction with other medicinal products and other types of interactions");

disorders where sodium restriction is indicated, such as mild to moderate heart failure, peripheral edema, generalized edema, pulmonary edema, preeclampsia, or extracellular hyperhydration (for more severe conditions, see Contraindications);

disorders where calcium intake restriction is indicated, such as sarcoidosis.

Patients receiving cardiac glycosides should use potassium- and calcium-containing solutions with caution (see section “Interaction with other medicinal products and other types of interactions”).

Solutions containing potassium salts should be administered with caution to patients with heart disease or conditions that may lead to hyperkalemia, such as renal or adrenocorticoid insufficiency, acute dehydration, or extensive tissue destruction in severe burns.

Due to the presence of calcium:

Care should be taken during intravenous administration to avoid extravasation and local irritation by calcium salts; in the case of simultaneous blood transfusion, this solution should not be administered through the same infusion system as blood components.

Use as a solvent

Please note: When using a medicinal product as a diluent, the safety information of the added substance, as approved by the relevant manufacturer, should be taken into account.

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

Clinical monitoring should include serum electrolytes, fluid balance, and pH.

With long-term parenteral treatment, the patient should be prescribed appropriate nutrition.

Elderly patients

Elderly patients, who are more likely to suffer from heart failure and renal impairment, should be closely monitored and the dose should be adjusted to avoid cardiac and renal complications caused by fluid overload.

Children

Intravenous therapy should be carefully monitored in children as well, as the ability to regulate fluids and electrolytes may be impaired.

It is necessary to ensure sufficient urine outflow.

Careful monitoring of fluid balance, plasma and urine electrolyte concentrations is important.

When providing short-term volume replacement in the event of bleeding or trauma, volume overload due to overdose should always be avoided.

For intravenous administration only.

For single use only.

Unused solution should be discarded.

Only a clear, practically particle-free solution should be used.

The solution should be administered using a sterile system using aseptic technique.

The system should be filled with solution to prevent air from entering.

When using the solution in plastic bags, the protective bag should be removed immediately before use.

Incompatibility: Mixing this medicinal product with medicinal products containing carbonates, phosphates, sulphates or tartrates may result in the formation of a precipitate.

Ability to influence reaction speed when driving vehicles or other mechanisms

Sterofundin ISO has no or negligible influence on the ability to drive or use machines.

Use during pregnancy or breastfeeding

There are no data on the use of Sterofundin ISO in pregnant and lactating women. Within the recommended indications, no risk is expected if the volume of solution administered, electrolyte levels and acid-base parameters are carefully monitored.

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

Method of administration and doses

The dose should be determined depending on the actual need to replenish water and electrolyte levels.

Adults

Maximum daily dose

The volume of the administered solution should not exceed 40 ml/kg body weight per day (which corresponds to 5.8 mmol of sodium per 1 kg of body weight and 0.16 mmol of potassium per 1 kg of body weight).

Additional fluid losses (e.g. due to fever, diarrhoea, vomiting, etc.) should be compensated depending on the volume and composition of the lost fluid. In case of dehydration, the dose of 40 ml/kg body weight per day may be exceeded.

In the treatment of acute fluid deficit, 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 kg body weight per hour and 20 micromol potassium per kg body weight per hour.

For short-term intravascular volume replacement, the maximum infusion rate depends on the patient's clinical situation.

In life-threatening situations, 500 ml of the drug can be administered quickly under manual pressure.

Solvent

When using Sterofundin ISO as a diluent, the dosage and infusion rate are determined primarily based on the characteristics and dosing regimen of the diluent.

Pediatric population

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

Maximum daily dose

These daily doses should not be exceeded.

Additional fluid losses (e.g. due to fever, diarrhea, vomiting, etc.) should be compensated depending on the volume and composition of the lost fluid.

In case of dehydration or short-term intravascular volume replacement, 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.

Infusion rate

Maximum infusion rate

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

Elderly patients

In general, the same doses as for adults are used, but attention should be paid to patients with diseases such as heart failure or renal failure, which may be associated with old age (see section "Special instructions").

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 between 4 and 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 administered into peripheral veins (for pH and theoretical osmolarity see section “Basic physical and chemical properties”).

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

During administration, fluid balance, plasma electrolyte concentration, and pH should be monitored.

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

Children

The drug can be used in children from 28 days of age according to indications.

Overdose

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

Excessive potassium intake can lead to hyperkalemia, especially in patients with renal insufficiency. Its symptoms include paresthesia of the extremities, muscle weakness, paralysis, cardiac arrhythmia, heart block, cardiac arrest, and confusion. Treatment of hyperkalemia includes the use of calcium, insulin (with glucose), sodium bicarbonate, exchange resins, or dialysis.

Excessive parenteral administration of magnesium salts leads to the development of hypermagnesemia, the important signs of which are the loss of deep tendon reflexes and respiratory depression, both manifestations resulting from neuromuscular blockade. Other symptoms of hypermagnesemia may include nausea, vomiting, flushing, thirst, hypotension due to peripheral vasodilation, dizziness, confusion, muscle weakness, bradycardia, coma, and cardiac arrest.

Excessive use of compounds that are metabolized to the bicarbonate anion, such as acetates and malates, can lead to metabolic alkalosis, especially in patients with impaired renal function. Its symptoms may include mood changes, fatigue, shortness of breath, muscle weakness, and cardiac arrhythmias (irregular heart rhythms). Patients with additional hypocalcemia may develop muscle hypertonia, muscle contractions, and seizures. Treatment of metabolic alkalosis associated with increased bicarbonate levels consists primarily of appropriate correction of fluid and electrolyte balance.

Excessive administration of calcium salts may 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 arrhythmias and coma. Very rapid intravenous administration of calcium salts may also cause numerous symptoms of hypercalcemia, including a chalky taste in the mouth, flushing and peripheral vasodilation. Mild asymptomatic hypercalcemia usually resolves after discontinuation of calcium and other drugs that contribute to its development, such as vitamin D. In case of severe hypercalcemia, urgent treatment is necessary (e.g., loop diuretics, hemodialysis, calcitonin, bisphosphonates, trisodium edetate).

If overdose is due to drugs added to the solution, the signs and symptoms of their excessive administration will also be related to the nature of the added substances. In the event of accidental overdose, treatment should be discontinued and the patient should be examined for relevant signs and symptoms related to the drug. Appropriate symptomatic and supportive measures should be taken as necessary.

Treatment.

Stop the infusion immediately. Further treatment depends on the nature and severity of symptoms and may include the administration of diuretics with frequent monitoring of electrolyte balance, correction of electrolyte and acid-base imbalances.

Treatment of hyperkalemia includes the use of calcium, insulin (with glucose), sodium bicarbonate, exchange resins, or dialysis.

Adverse reactions

Signs of overdose may occur (see section "Overdose").

Hypersensitivity reactions, including urticaria.

Possible hyperhydration, pulmonary edema, electrolyte disturbances

Although oral administration of magnesium salts stimulates peristalsis, paralytic ileus has been reported in rare cases following intravenous administration of magnesium sulfate.

Adverse reactions may be related to the injection technique, including febrile response, infection at the injection site, local pain or local reactions, vein irritation, venous thrombosis or phlebitis extending from the injection site, and extravasation. Adverse reactions may also be related to medications added to the solution; the nature of the added substances will determine the type of any other undesirable effects.

Expiration date

Shelf life when stored in polyethylene containers is 3 years.

From a microbiological point of view, the product should be used immediately after opening. If the solution is not administered immediately, the person administering the product is responsible for in-use storage times prior to use, which would normally not be longer than 24 hours at 2-8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Storage conditions

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

Packaging

500 ml; 10 containers in a cardboard box.

Vacation category

By prescription

Producer

B. Braun Melzungen AG/B. Braun Melsungen AG.

Location of the manufacturer and its business address

Carl-Braun-Strasse 1, 34212 Melsungen, Germany.