Instructions for Ringer's solution for infusion 200 ml
Composition
active ingredients: sodium chloride, potassium chloride, calcium chloride dihydrate;
1 ml of solution contains: sodium chloride – 8.60 mg; potassium chloride – 0.30 mg; calcium chloride dihydrate – 0.33 mg;
excipient: water for injections.
Ionic composition of the drug: sodium ion - 147.15 mmol/l; potassium ion - 4.0 mmol/l; calcium ion - 2.2 mmol/l; chloride ion - 155.6 mmol/l.
Dosage form
Solution for infusion.
Main physicochemical properties: clear colorless liquid; theoretical osmolarity – 309 mosmol/l; pH 5.0-7.5.
Pharmacotherapeutic group
Intravenous solutions. Solutions used to correct electrolyte imbalances.
ATX code B05B B01.
Pharmacological properties
Pharmacodynamics
Ringer's solution is an isotonic solution of electrolytes (Na+, K+, Ca2+ and Cl-) in the same concentration as in blood plasma, therefore its use does not lead to an increase in the concentration of these electrolytes in blood plasma, provided that the dosage is observed.
Ringer's solution is a rehydrating agent, has a detoxifying effect, normalizes the water and electrolyte composition of the blood. When used as a means of replenishing the volume of circulating blood, due to the rapid exit from the vascular bed into the intercellular space, the effect persists only for 30-40 minutes (the solution is suitable only for short-term replenishment of the volume of circulating blood).
The electrolytes Na+, K+, Ca2+, and Cl- are used to maintain or correct water-electrolyte homeostasis (including blood volume, osmotic balance, acid-base status, and the properties of specific ions).
Infusion of large amounts of chloride ions can cause loss of bicarbonate ions, leading to acidosis.
Pharmacokinetics
Since Ringer's solution is administered intravenously, its bioavailability is 100%.
Sodium and chlorine are predominantly distributed in the extracellular space, while potassium and calcium are distributed intracellularly.
The kidneys are the main regulators of water and electrolyte balance. Sodium and chlorine are mainly excreted through the kidneys, and in small quantities through the skin and gastrointestinal tract. 90% of potassium is excreted in the urine, 10% through the gastrointestinal tract. Calcium is excreted in approximately equal proportions by the kidneys and through the gastrointestinal tract.
The pharmacokinetics of each component of the solution does not change with their simultaneous administration.
Indication
Correction of water and electrolyte balance disorders in various pathological conditions, including hypochloremic alkalosis;
replenishment of the body with chlorides;
short-term replenishment of circulating blood volume;
isotonic dehydration;
hypotonic dehydration;
solvent for compatible concentrated electrolyte solutions and medicines.
Contraindication
Extracellular hyperhydration or hypervolemia;
hypertensive dehydration;
hyperkalemia;
hypernatremia;
hypercalcemia;
hyperchloremia;
hypercoagulation;
thrombophlebitis;
metabolic alkalosis;
severe renal failure (with oliguria/anuria);
decompensated heart failure;
severe arterial hypertension;
generalized edema (including pulmonary edema, cerebral edema) and ascites caused by liver cirrhosis;
simultaneous use with digitalis glycosides.
Interaction with other medicinal products and other types of interactions
Interaction due to the presence of sodium in the solution
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 due to the presence of potassium in the solution
With simultaneous use with potassium-sparing diuretics (amiloride, spironolactone, triamterene and similar), ACE inhibitors and possibly angiotensin II receptor inhibitors, as well as with tacrolimus, cyclosporine, suxamethonium and potassium preparations, the risk of developing hyperkalemia increases. An increase in the concentration of potassium in the blood plasma can lead to potentially fatal hyperkalemia, especially in the case of renal failure.
Potassium use may reduce the therapeutic effect of cardiac glycosides.
Corticosteroids and loop diuretics may increase renal potassium excretion.
Interaction due to the presence of calcium in the solution
Since calcium enhances the effect of cardiac glycosides, the simultaneous use of such a combination may lead to serious, including fatal cardiac arrhythmia.
Concomitant use of calcium preparations with thiazide diuretics or vitamin D may lead to hypercalcemia.
When used simultaneously with calcium-containing solutions of bisphosphonates, fluorides, fluoroquinolones and tetracyclines, the bioavailability (reduced absorption) of the above-mentioned drugs may decrease.
Interaction with ceftriaxone
Do not administer Ringer's solution and ceftriaxone simultaneously, even if different infusion systems and different injection sites are used (see section "Special instructions").
Application features
In patients with cardiac and/or pulmonary insufficiency, administration of large volumes of solution is possible only in exceptional cases, under the supervision of a physician.
During prolonged infusion therapy, it is necessary to determine laboratory parameters and give a clinical assessment of the patient's condition every 6 hours (depending on the infusion rate) to monitor electrolyte concentrations and water-electrolyte balance.
The use of intravenous solutions may cause fluid and/or solute overload, hyperhydration, congestion and pulmonary edema. The risk of dilution is inversely proportional to the electrolyte concentration. The risk of solution overload, leading to congestion with peripheral edema and pulmonary edema, is directly proportional to the electrolyte concentration.
Due to the content of sodium ions, the solution should be used with caution in patients with arterial hypertension, renal and cardiovascular failure, congestive heart failure, especially in the postoperative period, patients with preeclampsia, aldosteronism, elderly patients, as well as patients with clinical conditions accompanied by sodium retention and edema.
Sodium-containing solutions should be used with caution in patients receiving corticosteroids or corticotropin.
Due to the potassium content, caution is required when using the solution in patients with heart disease, clinical conditions accompanied by potassium retention in the body, such as renal failure or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction, which occurs in severe burns.
In patients with reduced renal excretory function, the use of the solution may lead to sodium or potassium retention.
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.
Fatalities have been reported due to the formation of ceftriaxone-calcium precipitates in the lungs and kidneys in premature infants and neonates less than 1 month of age. Ceftriaxone should not be mixed or administered simultaneously with any intravenous solutions containing calcium, even through separate infusion lines or into different infusion sites, in patients of any age.
Ringer's solution contains insufficient concentrations of potassium or calcium to be used to maintain the balance of these ions or correct their deficiency. Therefore, after treatment of dehydration, the intravenous infusion fluid should be replaced with a fluid that will provide balance of these ions.
Ringer's solution contains 147 mmol/L sodium. Special caution is recommended when administering to patients on a controlled sodium diet.
Ringer's solution contains 4 mmol/l potassium. Special caution is recommended when used in patients with impaired renal function or in patients on a controlled potassium diet.
If in an emergency the solution must be administered by pressure infusion, ensure that the container and infusion system are fully patent before starting the infusion.
Ringer's solution is intended for intravenous administration using sterile equipment. It is recommended that the intravenous line be changed at least every 24 hours.
The solution should only be used when it is clear and the bottle is airtight.
The physician should also consider the possibility of adverse reactions to medications used concurrently with Ringer's solution.
If an adverse reaction occurs, the infusion should be stopped, the patient's condition assessed, and appropriate therapeutic measures instituted.
Use during pregnancy or breastfeeding
No studies have been conducted on the use of Ringer's solution in pregnant women.
Caution should be exercised when used during pregnancy, especially in the case of eclampsia.
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 woman.
Ability to influence reaction speed when driving or using 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 rate and duration of infusion, the volume of the administered solution depends on the patient's clinical condition, body weight, age, type and degree of dehydration/hypovolemia, laboratory parameters and the use of other medications.
Maximum daily dose.
Maximum daily dose of electrolytes.
The maximum daily dose of potassium is 2 mmol/kg/day.
The maximum daily dose of sodium, depending on the need, is 3-6 mmol/kg/day. The maximum rate of administration.
The maximum infusion rate is 5 ml/kg body weight per hour.
The maximum drip rate is approximately 1.7 drops/kg body weight per minute.
When using Ringer's solution simultaneously with other intravenously administered drugs, their compatibility must be taken into account.
A dosage of 30 ml/kg of body weight per day satisfies only the body's basic physiological need for electrolytes.
In the postoperative period and in patients in the intensive care unit, due to limited renal concentration function and increased accumulation of metabolic end products, it is recommended to increase the dose to approximately 40 ml/kg body weight per day.
The basal cation requirement is approximately 1.5–3.0 mmol sodium/kg/day and 0.8–1.0 mmol potassium/kg/day.
Children.
Studies on the use of Ringer's solution in children have not been conducted.
Overdose
Overdose or too rapid administration of the solution may lead to fluid and sodium overload with the risk of edema, especially in the presence of impaired renal sodium excretion. In this case, hemodialysis may be necessary.
Excessive administration of the solution may lead to electrolyte and acid-base imbalance (hypernatremia, hypercalcemia, hyperchloremia), and hyperhydration.
In case of overdose of the drug administered simultaneously with Ringer's solution, appropriate therapy should be used.
Treatment.
Discontinuation of the drug, use of diuretics with constant monitoring of electrolyte balance, correction of electrolyte disturbances, in some cases hemodialysis may be required. Therapy is symptomatic.
Adverse reactions
Electrolyte metabolism disorders (potassium, calcium, sodium, chlorine), chloric acidosis, hyperhydration may occur; heart failure - in patients with heart disease or pulmonary edema; tachycardia; hypersensitivity reactions, allergic reactions; reactions at the injection site.
Adverse reactions may occur as a result of violations of the injection technique: febrile reactions, infections at the injection site, pain or reaction at the injection site, vein irritation, venous thrombosis or phlebitis extending from the injection site, and extravasation.
Adverse reactions may occur as a result of the addition of additional drugs to the solution; the nature of the added substance/drug determines the likelihood of the corresponding adverse reaction occurring.
In case of adverse reactions, the solution should be stopped, the patient's condition assessed and assistance provided.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions after the registration of a medicinal product plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Incompatibility
Before using Ringer's solution, its compatibility with other drugs that will be used simultaneously should be assessed.
To reduce the risk of possible incompatibility arising from mixing this solution with other prescribed additives, the final infusion solution should be inspected for turbidity or precipitation immediately after mixing, prior to use, and periodically during use.
Other drugs can be added to Ringer's solution only if they are soluble and stable in it, and have a similar pH.
Ringer's solution is incompatible with ceftriaxone (see section "Special instructions").
Calcium salts are known to be incompatible with a wide range of drugs. They may form complexes that result in precipitation. Drugs containing oxalates, phosphates, and carbonates/bicarbonates may precipitate when mixed with Ringer's solution.
Below is a list of drugs that are 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 or 400 ml in bottles; 250 ml or 500 ml in bags.
Vacation category
According to the recipe.
Producer
Limited Liability Company "Novopharm-Biosyntez".
Location of the manufacturer and address of its place of business.
Ukraine, 11700, Zhytomyr region, Novograd-Volynskyi, Zhytomyrska st., b. 38.
