SODIUM CHLORIDE INFUSION SOLUTION 0.9% 100ML

Clinico-pharmacological group Transfusiology

Pharmacotherapeutic group Rehydrating agent

Tradename Sodium chloride

International non-proprietary name Sodium chloride

Dosage Form Infusion Solution

Composition Sodium chloride 9 g, water for injection up to 1 l.

Pharmacological properties Pharmacodynamics

Plasma substitute. It has a detoxification and rehydrating effect. Replenishes sodium deficiency in various pathological conditions of the body. A 0.9% solution of sodium chloride is isotonic to human plasma and therefore is rapidly eliminated from the vascular bed, only temporarily increasing the volume of circulating blood (its effectiveness in blood loss and shock is insufficient).

Pharmacokinetics

Sodium concentration (Na +) - 142 mmol / l (plasma) and 145 mmol / l (interstitial fluid); chloride concentration (Сl-) - 101 mmol / l (interstitial fluid). Excreted by the kidneys in unchanged form.

Carefully Chronic heart failure, chronic renal failure (oligo-, anuria), acidosis, arterial hypertension, peripheral edema, toxicosis of pregnant women.

Indications for use Plasma-isotonic fluid replacement, hypochloremic alkalosis, hyponatremia with dehydration, intoxication, dissolution and dilution of parenterally administered drugs (as the base solution).

Contraindications Hypernatremia, hyperchloremia, hypokalemia; extracellular overhydration; intracellular dehydration; circulatory disorders associated with the risk of swelling of the brain and lungs; swelling of the brain; pulmonary edema; decompensated heart failure; conditions that can cause sodium retention, hypervolemia and edema (central and peripheral), such as: primary and secondary aldosteronism, caused for example by arterial hypertension, congestive heart failure, liver disease (including cirrhosis), kidney disease (including arterial stenosis and nephrosclerosis), pre-eclampsia; concomitant administration of glucocorticosteroids in large doses; contraindications to drugs added to the solution.

Use during pregnancy Data on the use of the drug during pregnancy and during breastfeeding is not enough. It is possible to use during pregnancy and during breastfeeding in cases where the expected benefit to the mother exceeds the possible risk of complications.

Dosage and administration Intravenous (drip).
Doses, speed and duration of use are selected individually depending on the indication for use, age, body weight, the patient's condition and concomitant therapy, as well as the effectiveness of treatment in terms of common symptoms and laboratory parameters. Before the introduction of the solution is heated to 36-38 ° C.The dose is determined depending on the loss of body fluids, sodium ions and chlorine and an average of 1000 ml / day as an intravenous continuous drip infusion with a speed of up to 180 drops / minute. With large losses of fluid and severe intoxication, it is possible to administer up to 3000 ml / day. The rate of introduction of 540 ml / h, if necessary, increase the rate of introduction.
Children with a pronounced decrease in blood pressure on the background of dehydration (before determining laboratory parameters, namely: determination of sodium, potassium, chlorine in the blood and urine; research on acid-base balance; determination of residual nitrogen and creatinine concentration in the blood plasma) are administered 20-30 mg / kg In the future, the dosing regimen is adjusted depending on laboratory parameters. With long-term administration of large doses of 0.9% sodium chloride solution, it is necessary to monitor in blood plasma and urine.

Side effect When used correctly, undesirable effects are unlikely. Adverse reactions recorded during post-marketing use are grouped by systems and organs according to the MedDRA dictionary and are listed below in descending order of severity, without indicating the frequency of occurrence.
On the part of the circulatory system: acidosis, overhydration, hypokalemia.
On the part of the immune system: hypersensitivity reactions or infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, pruritus.
General disorders and disorders at the injection site: reactions at the injection site, such as erythema, hemorrhage / hematoma, burning sensation, urticaria at the injection site; thrombosis or phlebitis at the injection site.
Other: fever, infections at the injection site (in violation of the rules of antiseptics).
When using the drug as a base solution (solvent) for other drugs, the likelihood of side effects is determined by the properties of these drugs. In this case, when side reactions appear, the solution should be stopped, the patient’s condition should be assessed, adequate measures should be taken and the remaining solution should be saved for analysis, if necessary.

Overdose Symptoms: nausea, vomiting, diarrhea, spastic abdominal pain, thirst, reduced salivation and tearing, increased sweating, fever, tachycardia, increased blood pressure, renal failure, peripheral edema, pulmonary edema, respiratory arrest, headache, dizziness, anxiety irritability, weakness, muscle cramps and stiffness, generalized cramps, coma and death. Excessive administration of sodium chloride solution 0.9% may cause hypernatremia. Excessive intake of chloride in the body can lead to hyperchloremic acidosis. If a solution of sodium chloride 0.9% is used as a basic solution for dilution and transport of other drugs, the symptoms and complaints with excessive administration are most often associated with the propertiesdrugs added to the solution. In the event of an unintentional over-injection of the solution, treatment should be stopped and the patient’s condition assessed.
Treatment: symptomatic.

Use with other drugs Compatible with colloidal hemodynamic blood substitutes (mutual enhancement effect).
When mixed with other drugs, it is necessary to visually monitor compatibility.

special instructions When conducting any infusion, it is necessary to monitor the patient's condition, clinical biological indicators, it is especially important to evaluate the electrolytes of the blood plasma.
In children, the excretion of sodium can be slowed down due to the immaturity of the kidney function. Therefore, in these patients, repeated infusions should be carried out only after determining the concentration of sodium in the blood plasma.
When hypersensitivity reactions or infusion reactions occur, the infusion should be stopped immediately and the necessary therapeutic measures should be taken as indicated.
Depending on the volume and rate of infusion on the background of intravenous administration of the drug, there may be a risk of hypervolemia and (or) overloading with solutes and electrolyte imbalances.
In patients with renal insufficiency, the drug should be used with extreme caution or not at all. The use of the drug in these patients may lead to sodium retention.
Use only a clear solution, no visible inclusions, and if the packaging is not damaged. Enter directly after connecting to the infusion system. The solution should be injected with the use of sterile equipment in compliance with the rules of asepsis and antisepsis. In order to avoid air entering the infusion system, it should be filled with a solution, releasing the residual air from the container completely.
As with all parenteral solutions, the compatibility of the added substances with the solution must be determined before dissolving. Do not use with a solution of sodium chloride 0.9% drugs, known as incompatible with it. To determine the compatibility of the added medicinal substances with a solution of sodium chloride 0.9% should be a doctor, checking for possible discoloration and / or the appearance of precipitate, insoluble complexes or crystals. Before adding, it is necessary to determine whether the added substance is soluble and stable in water at a pH level, as is the solution of sodium chloride 0.9%. When adding the drug, it is necessary to determine the isotonicity of the resulting solution before administration. Before adding drugs to the solution, they must be thoroughly mixed in compliance with the asepsis rules. The prepared solution should be entered immediately after preparation, do not store! Dispose of each unused dose.

Storage conditions In a dry place protected from light and aggressive media at a temperature of 5 to 25 ° C.Keep out of reach of children. Freezing of the solution during transportation, turbidity of the container and the presence of moisture in the package with the container under the condition of tightness of the container is allowed. After transportation in conditions of negative temperatures, the drug should be kept at a temperature of from 5 to 25 ° C for at least 24 hours.

Shelf life 2.5 years. Do not use after expiration date