Instructions for Ringer's solution for infusions container 400 ml
Composition
active ingredients: sodium chloride, potassium chloride, calcium chloride dihydrate;
100 ml of solution contain 0.86 g of sodium chloride, 0.03 g of potassium chloride, 0.0322 g of calcium chloride dihydrate;
excipient: water for injections.
Molar composition, mmol per 1000 ml of the drug: Na+ – 147.15 mmol; K+ – 4.0 mmol;
Ca++ – 2.2 mmol; Cl-– 155.6 mmol.
Dosage form
Solution for infusion.
Main physicochemical properties: transparent colorless liquid; theoretical osmolarity – 309 mosmol/l.
Pharmacotherapeutic group
Intravenous solutions. Solutions used to correct electrolyte imbalances.
Code ATXV05V V01.
Pharmacological properties
Pharmacodynamics.
Ringer's solution is a source of water and electrolytes. It can induce diuresis depending on the patient's condition.
Sodium is the main cation of extracellular fluid, participating primarily in the control of water distribution, water balance, and osmotic pressure of body fluids. Sodium is also associated with chlorine and bicarbonate in the regulation of acid-base balance of body fluids. Sodium plays an important role in neurotransmission and cardiac electrophysiology, as well as in renal metabolism.
Potassium is the main cation of intracellular fluid, participates in the utilization of carbohydrates and protein synthesis, is needed for the regulation of nerve conduction and muscle contraction, especially the heart. Potassium is important for many metabolic and physiological processes, including nerve conduction, muscle contraction and acid-base balance. The normal concentration of potassium in plasma is approximately 3.5 to 5.0 mmol per liter. Potassium is predominantly an intracellular cation, its highest concentration in the muscles; only about 2% of potassium is in the extracellular fluid. The transfer and retention of potassium ions in the cell is carried out against the concentration gradient by active transport using the enzyme Na + / K + ATPase.
Chloride is a major extracellular anion closely linked to sodium metabolism;
Changes in the body's acid-base balance are reflected by changes in the concentration of chloride ions. The introduction of large amounts of chloride ions can cause a decrease in bicarbonate concentration, which can lead to acidosis.
Calcium is an important cation that ensures the formation of bones and teeth (in the form of calcium phosphate and calcium carbonate). 99% of calcium is contained in bones and only about 1% in tissues and body fluids. In ionized form, calcium is necessary for the functioning of the blood clotting mechanism, normal heart function, and regulation of neuromuscular excitability.
The pH of Ringer's solution for infusion is 4.5-7.0.
Pharmacokinetics.
The pharmacokinetic properties of this solution are related to the properties of its components: sodium chloride, potassium chloride, calcium chloride.
The volume and ionic composition of the extracellular and intracellular parts of the fluid are as follows:
Extracellular fluid – approximately 19 liters:
sodium –142 mmol/l
potassium –5 mmol/l
calcium – 2.5 mmol/l
chloride – 103 mmol/l
intracellular fluid – approximately 23 liters:
sodium –15 mmol/l
potassium –150 mmol/l
calcium –1 mmol/l
chloride – 1 mmol/l
After administration of the radioisotope sodium (24Na), the half-life of the isotope is 11 to 13 days for 99% of the administered sodium. The decay of the isotope varies depending on the tissue: it is rapid in muscle, liver, kidney, cartilage, skin and very slow in erythrocytes, neurons and bone. Sodium is mainly excreted by the kidneys. Small amounts of sodium are excreted in feces and sweat.
Factors that affect the transfer of potassium between intracellular and extracellular fluids, such as acid-base disturbances, can alter the ratio of its concentration in plasma to the total amount in the body. Potassium is excreted mainly by the kidneys. It is secreted in the distal tubules in exchange for sodium ions and hydrogen ions. The kidneys have a poor capacity to retain potassium, so some potassium is excreted in the urine even when its concentration is significantly reduced. Some potassium is excreted in the feces and, in small quantities, also in sweat.
The concentration of calcium in the plasma is regulated by parathyroid hormone, calcitonin, and vitamin D. About 47% of the calcium in the plasma is in the ionized, physiologically active form, about 6% in the form of a complex with anions such as phosphates or citrates, and about 30% is bound to proteins, mainly albumin. Changes in the concentration of albumin in the blood plasma - an increase (as in dehydration) or a decrease (as can be observed in malignant processes) - affect the proportion of ionized calcium. Thus, the total concentration of calcium in the blood plasma usually correlates with the content of albumin in the blood plasma. Excess calcium is excreted by the kidneys, as well as with feces and bile. A small amount is excreted through the sweat glands of the skin and scalp. Calcium crosses the placenta and enters breast milk.
Indication
It is used for hypovolemia and extracellular dehydration due to prolonged vomiting, diarrhea, significant burns, frostbite, peritonitis, severe infectious diseases, shock, collapse; during surgery and in the postoperative period. It is used to dilute concentrated electrolyte solutions.
Contraindication
- Extracellular hyperhydration or hypervolemia;
- hypertensive dehydration;
- hypernatremia;
- hyperkalemia;
- hypercalcemia;
- hyperchloremia;
- hypercoagulation;
- thrombophlebitis;
- metabolic alkalosis;
- severe renal failure (with oliguria/anuria);
- decompensated heart failure;
- severe arterial hypertension;
- generalized edema (including pulmonary edema, brain edema) and ascites caused by liver cirrhosis;
- simultaneous use with digitalis glycosides.
Interaction with other medicinal products and other types of interactions
Interaction related to sodium ions.
Concomitant use of drugs such as steroids/corticoids, including androgens, estrogens, anabolic hormones, corticotropin, mineralocorticoids, carbenoxolone, may be accompanied by edema, hypertension, caused by sodium and water retention in the body.
Interaction related to potassium ions.
With simultaneous use with potassium-sparing diuretics (amiloride, pironolactone, triamterene and similar), ACE inhibitors and possibly angiotensin II receptor inhibitors, as well as with tacrolimus, cyclosporine and potassium preparations, the risk of developing hyperkalemia increases. An increase in plasma potassium concentration can lead to potentially fatal hyperkalemia, especially in the case of renal failure.
Interaction related to calcium ions.
Since calcium enhances the effect of cardiac glycosides, the simultaneous use of such a combination may lead to serious, including fatal cardiac arrhythmias. The simultaneous use of calcium preparations with thiazide diuretics or vitamin D may lead to hypercalcemia.
Application features
During prolonged parenteral therapy, it is necessary to monitor laboratory parameters and give a clinical assessment of the patient's condition to control the concentration of electrolytes and water-electrolyte balance every 6 hours (depending on the infusion rate). The introduction of significant volumes of the drug to patients with cardiac or pulmonary insufficiency requires monitoring of the functional state of these organs.
The use of Ringer's solution may lead to fluid and/or solute overload, which may result in decreased plasma electrolyte concentrations, hyperhydration, congestion, and pulmonary edema. The risk of dilution is inversely proportional to the concentration of electrolytes in the preparation. The risk of solute overload, resulting in an overload state with peripheral and pulmonary edema, is directly proportional to the concentration of electrolytes in the preparation.
Due to the fact that the drug contains sodium, the drug should be administered with caution to patients with hypertension, heart failure, renal failure, preeclampsia, aldosteronism, peripheral edema and pulmonary edema or when using certain medications (e.g. steroids/corticoids), as sodium ions may be retained in the body.
Due to the fact that the drug contains potassium, the administration of the drug requires caution when used in patients with heart disease or pathological conditions that can cause hyperkalemia: severe renal failure or severe adrenal insufficiency, acute dehydration or extensive tissue damage (for example, in the case of severe burns), as potassium ions may be retained in the body.
Due to the fact that the drug contains calcium, the drug should be administered under ECG control, especially in patients receiving cardiac glycosides. The concentration of calcium in the blood serum does not always reflect the concentration of calcium in the tissues. Care should be taken during intravenous administration of the drug to prevent hemorrhage. Caution should be exercised in patients with impaired renal function or diseases associated with increased vitamin D concentrations, such as sarcoidosis. Coagulation is possible when Ringer's solution is administered simultaneously with blood products; therefore, if such use is necessary, separate systems for transfusion and infusion should be used.
Ringer's solution for infusions has an insufficient content of potassium and calcium ions to maintain their content in the blood or correct their deficiency. Therefore, if it is necessary to correct the electrolyte balance after restoring the circulating fluid volume (eliminating dehydration), it is necessary to switch to appropriate drugs that will correct the concentration of potassium and calcium ions. With prolonged parenteral treatment, the patient must be provided with an accessible method of administering nutrients (food).
This solution is intended for intravenous administration using sterile equipment. It is recommended to change the intravenous line at least every 24 hours.
The physician should also consider the possibility of adverse reactions to drugs used concurrently with Ringer's solution.
If an adverse reaction occurs, the infusion should be stopped, the patient's condition assessed, and necessary therapeutic measures prescribed.
Use during pregnancy or breastfeeding
Studies on the use of Ringer's solution in pregnant women have not been conducted.
It is not known whether this drug is excreted in human milk. Because most drugs are excreted in human milk, caution should be exercised when Ringer's solution is administered to a nursing mother.
Ability to influence reaction speed when driving vehicles or other mechanisms
Data are missing due to the use of the drug exclusively in a hospital setting.
Method of administration and doses
The solution is intended for intravenous use only.
The dose is prescribed by a doctor and depends on the patient's age, body weight, clinical condition, and laboratory parameters.
The usual dose for an adult is up to 1-2 liters per day; the maximum dose depends on the state of water and electrolyte balance, cardiovascular system and kidneys.
Infusion rate for adults is 60-80 drops/min or jet.
The solution should be prescribed based on the estimated maintenance or replacement fluid requirements for each patient.
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration.
Children
Studies on the use of Ringer's solution in children have not been conducted.
Overdose
Administering too much solution may lead to fluid and electrolyte imbalance (hypervolemia).
Overdose or too rapid administration of water and sodium may lead to edema, especially in cases of impaired renal sodium excretion.
Treatment of hypervolemia. At the first symptoms of hypervolemia, the drug should be discontinued and hemodialysis should be performed.
Excessive potassium intake can lead to hyperkalemia, especially in patients with renal insufficiency. Symptoms include paresthesias of the extremities, muscle weakness, paralysis, cardiac arrhythmias, heart block, cardiac arrest, and confusion.
Treatment of hyperkalemia. At the first symptoms, it is necessary to stop the administration of the drug and start the administration of calcium, insulin (with glucose), sodium bicarbonate. The use of ion exchange resins or hemodialysis is effective.
Excessive administration of calcium salts can lead to hypercalcemia. Symptoms of hypercalcemia may include loss of appetite, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disorders, polydipsia, polyuria, nephrocalcinosis, kidney stones, and in severe cases, cardiac arrhythmias and coma. If calcium salts are administered intravenously too rapidly, many of the symptoms of hypercalcemia may occur, as well as flushing and peripheral vasodilation.
Treatment of hypercalcemia. At the first symptoms of hypercalcemia, the drug should be discontinued. Mild asymptomatic hypercalcemia usually resolves after discontinuation of calcium and other drugs that contribute to its development, such as vitamin D. In case of serious manifestations, urgent treatment aimed at increasing diuresis is necessary (for example, the use of loop diuretics, hemodialysis, calcitonin, bisphosphonates, trisodium edetate).
Excessive chloride administration can lead to bicarbonate loss with the effect of acidosis.
Treatment: Appropriate symptomatic and supportive measures should be taken as necessary.
Adverse reactions
Electrolyte metabolism disorders (potassium, calcium, sodium, chlorides), chloride acidosis, hyperhydration are possible.
In case of adverse reactions, the administration of the solution should be stopped, the patient's condition should be assessed and appropriate assistance should be provided.
The following adverse reactions have been commonly observed with Ringer's solution:
- hyperhydration, heart failure in patients with heart disorders, pulmonary edema;
- electrolyte imbalance.
Adverse reactions may be related to the injection technique, including fever, infections, pain or reactions at the injection site, vein irritation, venous thrombosis or phlebitis extending from the injection site, and hemorrhage. Adverse reactions may be related to the drug added to the solution, which will determine the likelihood of any other adverse effects. If any adverse effects occur, the drug should be discontinued.
In case of undesirable manifestations, side reactions or in case of lack of therapeutic effect, it is necessary to inform the State Enterprise "Pharmatrade" at the address: 85 Sambirska St., Drohobych, Lviv region, Ukraine, 82111 or by phone: /03244/ 2-40-27, 3-80-71; Fax É: / 03244/ 3-99-94, mob. tel. +38-099-729-37-89; E-mail: pharmatrade @mail.lviv.ua, natali_gudz@ukr.net
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Incompatibility.
Calcium salts are known to be incompatible with a wide range of drugs. They may form complexes that result in precipitation. The following is a list of drugs known to be incompatible with Ringer's solution and should not be mixed (this list is not exhaustive):
- amphotericin B;
- cortisone;
- erythromycin lactobionate;
- etamivan;
- ethyl alcohol;
- sodium thiopental;
- disodium edetate;
Packaging
200 ml, 250 ml, 400 ml or 500 ml in polyvinyl chloride containers.
Vacation category
According to the recipe.
Producer
Subsidiary company "Pharmatrade".
Location of the manufacturer and address of its place of business
85 Sambirska St., Drohobych, Lviv region, Ukraine, 82111.
Applicant
Subsidiary company "Pharmatrade".
Applicant's location
85 Sambirska St., Drohobych, Lviv region, Ukraine, 82111.
