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% sodium chloride solution is isotonic with human plasma and thus rapidly cleared from the vascular bed, but temporarily increasing the circulating blood volume (blood loss and efficiency when 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; intracellular dehydration; circulatory disorders associated with the danger of developing edema of the brain and lungs; cerebral edema; pulmonary edema; Uncompensated heart failure; states that can cause sodium retention, edema hypervolaemia and (central and peripheral), such as: primary aldosteronism and secondary aldosteronism,for example, arterial hypertension, congestive heart failure, liver disease (including cirrhosis), kidney disease (including arterial stenosis 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, arterial hypertension, peripheral edema, toxicosis of pregnant women.

Pregnancy and lactation:

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 those cases when the expected benefit for the mother exceeds the possible risk of complications.

Dosing and Administration:

Isotonic sodium chloride solution for infusions is administered intravenously (usually drip). The required dose can be calculated in mEqV or mole of sodium, the mass of sodium ions or the mass of sodium chloride (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol Na and Cl). Before administration, the solution is heated to 36-38 ° C.The dose is determined depending on the patient's condition, body fluid loss, sodium and chloride ions, age, body weight of the patient. Serum concentrations of electrolytes in blood plasma and urine should be closely monitored. The dose of sodium chloride solution for adults is: from 500 ml to 3.0 liters per day. The rate of administration is 540 ml / h (180 cap / min); if necessary, the rate of administration is increased. The dose of sodium chloride solution for children is: from 20 ml to 100 ml per day per kg of body weight (depending on age and total body weight). Children with a marked decrease in blood pressure on the background of dehydration (without determining the laboratory parameters) are administered 20-30 ml / kg. In the future, the dosage regimen is adjusted in dependence on the laboratory parameters (Na electrolytes⁺, K⁺, Cl^-, acid-base state of blood). The recommended dose when used for dilution and dissolution of parenterally administered drugs (as a solvent base solution) is in the range of 50 ml to 250 ml per dose of the drug administered. In this case, the dose and rate of administration of the solution are determined by the recommendations for the administration of the drug administered.

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 at the injection site, bleeding / hematoma at the injection site, burning sensation, hives at the site of injection; thrombosis or phlebitis at the site of administration.

Other: fever, infection at the injection site (for violations of the rules of antiseptics).

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.

If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

Symptomsnausea, vomiting, diarrhea, spastic pain in the abdomen, thirst, reduced salivation and lacrimation, 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 the solution can cause hypernatremia. Excessive intake of chloride into the body can lead to a deficit of bicarbonates and hyperchloremic acidosis. When used as a base solution for dilution and dissolution of other drugs, symptoms and complaints with excessive administration are most often associated with the properties of the drugs administered. In case of unintended excess solution administration, treatment should be discontinued and the patient's condition assessed.

Treatment: symptomatic.

Interaction:

Compatible with colloid hemodynamic blood substitutes (mutual enhancement of the effect). When mixed with other drugs, you need to visually check for compatibility. To do this, it is necessary to observe the resulting solution to change its color and / or precipitate, the appearance of crystals, insoluble complexes. It is also necessary to take into account the instructions for the use of added drugs.

Special instructions:

When carrying out any infusion, it is necessary to observe the patient's condition, clinical and biological indicators, it is especially important to evaluate plasma electrolytes. 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 packaging 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 must be determined before dissolution. Do not apply with 0.9% sodium chloride solution preparations known to be incompatible with it. Determine the compatibility of added drugs with a 0.9% sodium chloride solution should the doctor check the possible discoloration 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! Do not freeze! 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, 200, 250, 400, 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000, 4500 or 5000 ml into polymeric containers for single-use infusion solutions with two sterile ports. One or two containers are placed in a bag of polyethylene or polyethylene-polyamide film (a double sterile vacuum package).

Containers in bags are placed in a box of corrugated cardboard with gaskets: 75 pieces (50 ml), 50 pieces (100 ml), 30 pieces (200 ml), 24 pieces (250 ml), 15 pieces (400 ml ), on 12 pieces (500 ml), on 6 pieces (1000 ml), on 4 pieces (1500 ml), on 4 pieces (1500 ml + 250 ml), on 4 pieces (2000 ml), on 4 pieces (2500 ml), 3 pieces (3000 ml), 3 pieces (3500 ml), 2 pieces (4000 ml), 2 pieces (4500 ml), 2 pieces each (5000 ml).In the box with bags put the appropriate number of instructions for use (for hospitals).

Storage conditions:

At a temperature of 5 to 30 ° C. Keep out of the reach of children. It is allowed to freeze the drug provided the container is kept tight.

Shelf life:

2 years.

The drug should not be used after the expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:P N003232 / 01

Date of registration:29.01.2009 / 29.11.2013

Expiration Date:Unlimited

The owner of the registration certificate:MEDSINTEZ FACTORY, LTD. MEDSINTEZ FACTORY, LTD. Russia

Manufacturer: & nbsp

PLANT MEDSINTEZ, LLC Russia

Information update date: & nbsp15.06.2018

Illustrated instructions

Instructions

Sodium chloride (Sodium chloride)