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Composition:


active ingredients: sodium chloride; potassium chloride; calcium chloride dihydrate; magnesium chloride hexahydrate; sodium acetate trihydrate; L-malic acid;


1 ml of the solution contains sodium chloride 6.80 mg, potassium chloride 0.30 mg, calcium chloride dihydrate 0.37 mg, magnesium chloride hexahydrate 0.20 mg, sodium acetate trihydrate 3.27 mg, L-malic acid 0.67 mg;


electrolyte concentration: sodium – 145.0 mmol/l; Potassium-4.0 mmol/ L; calcium – 2.5 mmol / L; magnesium-1.0 mmol / L; chlorides-127.0 mmol/L; acetates – 24.0 mmol/L; malates – 5.0 mmol / L;


excipients: sodium hydroxide, water for injection.


Dosage form. Solution for infusions.


Basic physical and chemical properties: transparent colorless liquid. 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 balance disorders. Electrolytes. ATX code B05B B01.


Pharmacological properties.


Pharmacodynamics.


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 (i.e., the loss of water and electrolytes in proportional amounts). The purpose of introducing 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 Plasmoven® is administered intravenously, its bioavailability is 100 %.


Sodium and chlorides are distributed mainly in the extracellular space, while potassium, magnesium and calcium are distributed mainly intracellularly. The kidneys are the main route of elimination of sodium, potassium, magnesium and chloride, although a small amount of electrolytes is lost through the skin and digestive tract. calcium is excreted in the urine and by internal intestinal secretion in approximately equal amounts.


During the infusion of acetates and malates, their plasma levels increase until they reach equilibrium levels. After stopping the infusion, the concentration of anions decreases rapidly. Urinary excretion of acetates and malates increases during infusion, but their metabolism in the body's tissues is so rapid that only minor fractions are detected in the urine.


Clinical characteristics.


Indications.


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


Contraindications.


Hypersensitivity to any active or auxiliary substance 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.


Interactions with other drugs and other types of interactions.


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


Medications that cause sodium retention.


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


Drugs that interact with potassium.


Suxamethonium, ACE inhibitors, NSAIDs, potassium-sparing diuretics (amiloride, spironolactone, Triamterene, alone or in combination), tacrolimus, cyclosporine can increase the concentration of potassium in plasma and lead to potentially fatal hyperkalemia, especially in the case of renal failure, which increases the hyperkalemic effect and can lead to cardiac arrhythmia.


Potassium administration may reduce the therapeutic effect of cardiac glycosides. ACTH, corticosteroids, and loop diuretics may increase renal potassium elimination.


Drugs that interact with calcium.


The effect of digitalis glycosides (digitalis cardiotonics) in hypercalcemia can increase and lead to serious or fatal cardiac arrhythmia.


Thiazide diuretics and vitamin D can cause hypercalcemia. Calcium complexes make tetracycline antibiotics inactive.


Drugs that interact with Malate.


Alkalization of urine after administration of the precursor bicarbonate or bicarbonate leads to an increase in the renal clearance of acid-containing drugs.


The Half-Life of essential drugs, especially sympathomimetics (for example, ephedrine, pseudoephedrine) and stimulants (for example, dexamphetamine sulfate, fenfluramine hydrochloride), is extended if solutions containing Malate are administered simultaneously.


Application features.


Large-volume infusions can be used in patients with mild to moderate heart or respiratory failure with careful monitoring (for more severe conditions, see the section "contraindications").


Plasmoven® should be administered with extreme caution and with constant monitoring in patients with conditions such as:


- hypernatremia;


- hyperchloremia;


- kidney failure;


- coma of unknown origin;


- simultaneous treatment with digitalis preparations;


- hyperkalemia or conditions that can lead to hyperkalemia, in particular Addison's disease, sickle cell anemia;


- hypertensive dehydration, arterial hypertension, impaired renal function, existing or threatening eclampsia, aldosteronism or other conditions, or when co-treated with drugs (e.g. corticosteroids/steroids) that are associated with sodium retention and drugs that increase serum potassium levels (See also the section " interactions with other drugs and other types of interactions»);


- disorders where sodium intake 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 the section " contraindications»);


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


Patients receiving cardiac glycosides should use potassium-containing and calcium-containing solutions with caution (see the section "interactions with other drugs and other types of interactions").


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

Dosage and administration.


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


Adults.


Maximum daily dose.


The volume of the administered solution should not exceed 40 ml/kg of 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 (for example, due to fever, diarrhea, vomiting) should be compensated depending on the volume and composition of the lost fluid. In case of dehydration, the dose of 40 ml/kg of body weight per day may be exceeded.


The dose should be calculated based on the severity of dehydration and the patient's clinical condition.


In the treatment of acute fluid deficiency, namely severe or life-threatening hypovolemic shock, it is allowed to use higher doses, for example, by rapid infusion (under pressure).


Maximum infusion rate.


The infusion rate of the drug should not exceed 100 ml per hour.


In the treatment of dehydration, the maximum infusion rate is 5 ml/kg of body weight per hour, which corresponds to 0.7 mmol of sodium per 1 kg of body weight per hour and 20 mmol of potassium per 1 kg of body weight per hour.


With short-term replenishment of intravascular volume, the maximum infusion rate depends on the patient's clinical situation.


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


Solvent.


When using Plasmoven® as a solvent, the dosage and infusion rate are determined mainly based on the characteristics and dosage regimen of the dissolved agent.


Pediatric population.


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

Overdose.


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


Excessive potassium administration 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 for 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, important signs of which are loss of a deep tendon reflex and respiratory depression, both manifestations occur due to neuromuscular blockade. Other symptoms of hypermagnesemia may include nausea, vomiting, redness of the skin, thirst, hypotension due to dilated peripheral vessels, dizziness, confusion, muscle weakness, bradycardia, coma, and cardiac arrest.


Excessive administration of chlorides can lead to loss of bicarbonate with acidosis.


Excessive use of compounds 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 swings, fatigue, shortness of breath, muscle weakness, and cardiac arrhythmia (a heart rhythm disorder). Patients with additional hypocalcemia may develop muscle hypertonicity, muscle contractions, and seizures. Treatment of metabolic alkalosis associated with an increase in bicarbonate levels consists mainly in appropriate correction of fluid and electrolyte balance.


Excessive administration 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 stone formation, 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 chalky taste in the mouth, hot flashes and dilation of peripheral blood vessels. Mild asymptomatic hypercalcemia usually resolves after discontinuation of calcium and other medications that cause its development, such as vitamin D. In case of severe hypercalcemia, urgent treatment is necessary (for example, the use of loop diuretics, hemodialysis, calcitonin, bisphosphonates, trisodium edetate).


If the overdose is associated with 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 case of accidental overdose, treatment should be discontinued and the patient should be examined for appropriate 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 imbalances.


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


Adverse reactions.


Signs of overdose may appear (see the section "overdose").


Hypersensitivity reactions, including urticaria.


Possible hyperhydration, pulmonary edema, electrolyte disorders.


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


Adverse reactions may be related to the injection technique, including febrile response, infections at the injection site, 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, and the nature of the added substances will determine the type of any other undesirable effects.


Reports of suspected adverse reactions.


Reporting suspected adverse reactions after drug registration is an important procedure. This allows you to continue monitoring the benefit/risk ratio for the drug in question. Health professionals should report any suspected adverse reactions through the National notification system.

Incompatibility.


Mixing this medicine with medications containing carbonates, phosphates, sulfates, or tartrates can lead to sediment formation.

Tags: Plasmovein