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

Plasma-substituting agent. Has a detoxifying and rehydrating effect.Replenishes sodium deficiency 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 mol / 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; Decompensated heart failure: conditions that can cause sodium retention, hypervolemia and edema (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 (oligoanuria), acidosis, arterial hypertension, peripheral edema, and toxicosis of pregnant women.

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, the patient's condition and concomitant therapy, as well as 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 the determination of laboratory parameters, namely determination of sodium, potassium, chlorine in the blood and urine, study of acid-base equilibrium, determination of residual nitrogen and creatinine concentration in the blood), 20-30 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 carry out control in plasma and urine.

Side effects:

If used correctly, undesirable effects are unlikely.

The undesirable reactions recorded during the postmarketing application are grouped according to the systems and organs in accordance with the vocabulary MedDRA and are listed below in descending order of their 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 site of administration 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 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.

Overdose:

Symptoms: nausea, vomiting, abdominal cramps, thirst, reduced saliva 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 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 administration of the drug, there is a risk of developing hypervolemia and (or) overloading with dissolved substances and disturbance of electrolyte balance.

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.

Use only a clear solution, without 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 a precipitate of 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 similar to that of sodium chloride of 0.9%. 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 infusions, 0,9%.

Packaging:

For 100, 200, 250, 400 or 500 ml of the preparation in polypropylene bottles with holder loop, sealed with polypropylene lids with rubber lining and equipped with caps with tear-off rings for opening, welded onto the vial.

One bottle, along with instructions for medical use in consumer packaging (a pack of cardboard).

For hospitals

100, 200, 250, 400 or 500 ml of the preparation into polypropylene bottles with a holder loop, sealed with polypropylene lids with rubber lining and equipped with caps with tear-off rings for opening, welded onto the vial.

120 vials of 100 ml, together with an equal number of instructions for medical use, are placed in a group package (carton box).

40 bottles of 200 ml or 250 ml, together with an equal number of instructions for medical use, are placed in a group package (carton box).

30 bottles of 400 ml or 500 ml together with an equal number of instructions for medical use are placed in a grouppacking (cardboard box).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003458

Date of registration:16.02.2016

Expiration Date:16.02.2021

The owner of the registration certificate:Kelun-Kazfarm, TOOKelun-Kazfarm, TOO The Republic of Kazakhstan

Manufacturer: & nbsp

Kelun-Kazpharm, TOO The Republic of Kazakhstan

Representation: & nbspKelun-Kazfarm, TOOKelun-Kazfarm, TOOThe Republic of Kazakhstan

Information update date: & nbsp16.06.2018

Illustrated instructions

Instructions

Sodium chloride (Sodium chloride)