Sodium chloride - instructions for use, dose, side effects, contraindications

Plasma-substituting agent. Has a detoxifying and rehydrating effect. Replenishes the deficiency of sodium ions in various pathological conditions. 0.9% solution of sodium chloride is isotonic with human plasma, and therefore it is rapidly excreted from the vascular bed, only temporarily increasing the volume of circulating blood (effectiveness with blood loss and shock is insufficient).

Pharmacokinetics:

The concentration of sodium ions is 142 mmol / l (plasma) and 145 mmol / l (interstitial fluid), the chloride concentration is 101 mmol / l (interstitial fluid). It is excreted by the kidneys.

Indications:

Plasmo-isotonic substitution of fluid, hypochloraemic alkalosis, hyponatremia with dehydration, intoxications, dissolution and dilution of parenterally administered drugs (as a base solution).

Contraindications:

Hypernatremia, hyperchloremia, hypokalemia; extracellular hyperhydration; extracellular dehydration; hyperchloremia, circulatory disorders associated with the danger of developing edema of the brain and lungs; cerebral edema; pulmonary edema; Decompensated heart failure; states that can cause sodium retention,hypervolaemia and edema (central and peripheral), such as: primary aldosteronism and secondary aldosteronism, caused, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), kidney disease (including stenosis of arteries and nephrosclerosis), preeclampsia; concomitant administration of glucocorticosteroids in large doses; contraindications to the drugs added to the solution.

Carefully:

Chronic heart failure, chronic renal failure (oligo-, anuria), acidosis, hypertension, peripheral edema, toxemia of pregnancy.

Pregnancy and lactation:

Data on the use of the drug during pregnancy and during breastfeeding is not enough. Possible application in pregnancy and during breastfeeding in those cases when the expected benefit for the mother exceeds the possible risk of complications.

Dosing and Administration:

Intravenously (drip). Doses, speed and duration of application are selected individually depending on the indication for use, age, body weight, patient's condition and concomitant therapy,and on the effectiveness of treatment in terms of general symptoms and laboratory indicators. Before administration, the solution is heated to 36-38 ° C. The dose is determined depending on the loss of body fluids, sodium and chloride ions and on average is 1000 ml / day as an intravenous continuous drop infusion at a rate of up to 180 drops / minute. With large fluid loss and severe intoxication, administration of up to 3000 ml / day is possible. The rate of administration is 540 ml / h, if necessary, the rate of administration is increased. Children with a marked decrease in blood pressure on the background of dehydration (before determining laboratory parameters, namely: determination of sodium, potassium, chlorine in blood plasma and urine, study of acid-base equilibrium, determination of residual nitrogen and creatinine concentration in blood plasma) mg / kg. In the future, the dosage regimen is adjusted depending on the laboratory parameters. With prolonged administration of large doses of 0.9% solution of sodium chloride, it is necessary to monitor blood and urine.

Side effects:

If used correctly, undesirable effects are unlikely.The undesirable reactions recorded during the postmarketing application are grouped according to the MedDRA dictionary and are listed below in order of decreasing severity, without indicating the frequency of occurrence.

On the part of the circulatory system: acidosis, hyperhydration, hypokalemia.

From the immune system: hypersensitivity reactions or infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, itching.

General disorders and disorders at the site of administration: reactions at the injection site, such as erythema, hemorrhage / hematoma, burning sensation, urticaria at the injection site; thrombosis or phlebitis at the site of administration. Other: fever, infection at the injection site (in violation of the rules of antiseptic).

When using the drug as a base solution (solvent) for other drugs, the probability of side effects is determined by the properties of these drugs. In this case, if side effects occur, you should suspend the solution, assess the patient's condition, take adequate measures and save the remaining solution for analysis, if necessary.

Overdose:

Symptomsnausea, vomiting, diarrhea, spastic abdominal pain, thirst, reduced salivation and tear, 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 convulsions, coma and death. Excessive administration of 0.9% sodium chloride solution can cause hypernatremia. Excessive intake of chloride into the body can lead to hyperchloremic acidosis. If a solution of sodium chloride 0.9% is used as a base solution for the dilution and transport of other drugs, symptoms and complaints with excessive administration are most often associated with the properties of drugs added to the solution. In case of unintended excess solution administration, treatment should be discontinued and the patient's condition assessed. Treatment: symptomatic.

Interaction:

When mixed with other medicines, visual compatibility checks are required (there may be chemical or therapeutic incompatibility).Compatible with colloid hemodynamic blood substitutes (mutual enhancement of the effect).

Special instructions:

When carrying out any infusion, it is necessary to observe the patient's condition, for clinical biological indicators, it is especially important to evaluate electrolytes of blood plasma. In the body of children, because of the immaturity of kidney function, sodium excretion can be slowed down. Therefore, in such patients, repeated infusions should be performed only after determining the concentration of sodium in the blood plasma. When hypersensitivity reactions or infusion reactions appear, the infusion should be stopped immediately and the necessary therapeutic measures taken after the indications. Depending on the volume and speed of infusion against the background of intravenous drug administration, there is a risk of developing hypervolemia and (or) overloading with dissolved substances and electrolyte balance disorders. In patients with renal insufficiency, the drug should be used with extreme caution or not at all. The use of the drug in such patients can lead to sodium retention. Apply only a clear solution, with no visible inclusions and if the package is not damaged.Enter directly after connecting to the infusion system. The solution should be administered with the use of sterile equipment in compliance with the rules of aseptic and antiseptic. To avoid ingress of air into 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 should be determined before dissolution. Do not apply with 0.9% sodium chloride solution preparations known to be incompatible with it. Determine the compatibility of the added drugs with the sodium chloride solution 0,9% should the doctor, checking possible changes in color and / or the appearance of sediment, insoluble complexes or crystals. Before adding, it is necessary to determine whether the added substance is soluble and stable in water at the pH level as 0.9% sodium chloride solution. When adding the drug, it is necessary to determine the isotonicity of the solution obtained before administration. Before adding to the solution of the preparations, they must be thoroughly mixed in accordance with the rules of asepsis.Prepared solution should be introduced immediately after preparation, do not store! Dispose of each unused dose.

Effect on the ability to drive transp. cf. and fur:Clinical studies to assess the effect of the drug on the ability to manage vehicles and mechanisms have not been conducted.

Form release / dosage:

Solution for infusion 0.9%.

Packaging:

50, 100, 150, 200, 250, 300, 350, 400, 450, 500, 750, 800, 1000, 1250, 1500, 2000, 2500, 3000, 3500, 4000, 4500 or 5000 ml in self-falling containers of polymer single-use infusion solutions of one or two ports for infusion solutions or a transparent multilayer polyolefin film (without polyvinylchloride) with one or two separate polypropylene injection ports of the SFC type equipped with liners of an injection unit made of polyisoprene or of a thermoplastic elastomer sealed with polypropylene to laps providing control of the "first opening" or in packets for intravenous infusions, or 3000 and 5000 ml in packages of polyolefin for bottling and storage of infusion solutions. The containers are sterilized with a steam-water mixture at a temperature of (120⁺²)FROM.Each container has a hinge for suspending, a reserve volume, for additional drug administration of at least 35% of the container volume, the possibility of using a system for infusion without an air valve. Containers are compatible with a two-sided cannula for mixing solutions.

Each container or package for intravenous infusions is labeled using silk screen printing or hot stamping.

Each container or package for intravenous infusion is packaged in a secondary package with instructions for use applied to it.

The secondary package is made of polypropylene or high-density polyethylene. Containers or bags in the secondary packaging are placed in transport containers (corrugated cardboard boxes).

Containers made of polyolefin film can be packed in transport containers (corrugated cardboard boxes) without a secondary package (for hospitals). Instructions for use in a container with containers in an amount equal to the number of containers.

Storage conditions:

In a place inaccessible to children at a temperature of no higher than 25 ° C. Freezing during transportation is allowed.

Shelf life:

3 years - for the preparation in polymeric containers made of polyvinyl chloride film or in packets for intravenous infusions. 4 years - for the preparation in containers of polyolefin film. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N003758 / 01

Date of registration:19.09.2011 / 28.02.2017

Expiration Date:Unlimited

The owner of the registration certificate:FIRM MEDPOLIMER, JSC FIRM MEDPOLIMER, JSC Russia

Manufacturer: & nbsp

FIRM MEDPOLIMER, JSC Russia

Information update date: & nbsp15.06.2018

Illustrated instructions

Instructions

Sodium chloride (Sodium chloride)