Sodium chloride, 0.9% 5 ml 10 pcs

Pharmacotherapeutic group: Rehydrating agent

ATC:

.

Indications

Active ingredient

Composition

1 liter of the solution contains:

the active ingredient:

Sodium chloride – 9.0 g;

excipient:

water for injection – up to 1.0 l.

Theoretical osmolarity is 308 mOsm/L.

How to take, the dosage

Isotonic sodium chloride solution for infusion is administered intravenously (usually by drip). Doses, rate and duration of administration are selected individually depending on the indication for use, age, body weight, patient’s condition and concomitant therapy, as well as the effectiveness of treatment in terms of general symptoms and laboratory parameters. The required dose can be calculated in mEq or mmol sodium, mass of sodium ions or mass of sodium chloride (1 g NaCl = 394 mg, 17.1 mEq or 17.1 mmol Na and Cl).

The solution is heated to 36-38 °C before administration. Serum electrolyte concentrations in plasma and urine should be carefully monitored.

The dose of sodium chloride solution for adults is 500 ml to 3.0 liters per day. The infusion rate is 540 ml/h (180 drops/min); if necessary, the infusion rate 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). In children with a marked decrease in blood pressure against the background of dehydration (without determining the laboratory parameters) 20-30 ml/kg are administered.

Thereafter, the dosing regimen is adjusted depending on the laboratory parameters (electrolytes Na+, K+, Cl-, acid-base state of blood). The recommended dosage when used for dilution and dissolution of parenterally administered drugs (as a basic solvent) ranges from 50 ml to 250 ml per one dose of the administered drug. In this case, the dose and rate of administration of the solution are determined by the recommendations for the use of the administered drug.

The Polyflac EN bottle (a bottle with a head designed to connect a standard infusion system):

1. Place the vial vertically on a horizontal surface.

2. Remove the cap.

3. disinfect the port of the bottle with the disinfectant.

4. Prepare the infusion system.

5. Insert the spike (or injection needle) into the marked chamfer on the port at right angles until the dropper skirt (or butterfly of the injection needle) touches firmly.

6. Turn the vial over and secure the system to the infusion stand (tripod).

Note

Interaction

Compatible with colloidal hemodynamic blood substitutes (mutual enhancement of effect).

When mixing with other medicinal products a visual check for compatibility is necessary (chemical or therapeutic incompatibility may occur).

Special Instructions

In any infusion, the patient’s condition and clinical and biological parameters should be monitored, especially plasma electrolytes.

In children, sodium excretion may be delayed due to immature renal function. Therefore, in such patients repeated infusions should be carried out only after determining the plasma sodium concentration.

Hypersensitivity reactions

There have been reports of hypersensitivity or infusion reactions including hypotension, pyrexia, tremor, chills, urticaria, rash and pruritus during use. If hypersensitivity reactions or infusion reactions occur, the infusion should be stopped immediately and appropriate therapeutic measures taken as indicated.

Risk of hypervolemia and/or solute overloading and electrolyte imbalances

Depending on the volume and rate of infusion, the following conditions may develop with intravenous administration of the drug:

Manual use in patients with renal impairment

The drug should be used with extreme caution or not at all in patients with renal impairment. Use of the drug in these patients may lead to sodium retention.

To use only a clear solution without visible inclusions and if the package is not damaged.

Inject immediately after connecting to an infusion system. The solution should be administered using sterile equipment, following aseptic and antiseptic procedures. The infusion system should be filled with the solution, releasing any residual air from the container completely to prevent air from entering the infusion system.

As with all parenteral solutions, the compatibility of the added substances with the solution must be determined prior to dissolution. Drugs known to be incompatible with 0.9% sodium chloride solution should not be used. The compatibility of added medications with 0.9% sodium chloride solution must be determined by the physician by checking for possible color changes and/or the appearance of precipitate, insoluble complexes or crystals. Before adding, it must be determined whether the substance to be added is soluble and stable in water at the same pH as the 0.9% sodium chloride solution. If the drug is added, the isotonicity of the resulting solution must be determined prior to administration.

Before adding the drugs to the solution, they should be thoroughly mixed observing the rules of asepsis. The prepared solution should be administered immediately after preparation, do not store! Do not freeze! Each unused dose should be disposed of. Addition of other drugs or violation of the administration technique may cause fever due to possible ingestion of pyrogens. If unwanted reactions develop, the administration of the solution should be stopped immediately.

The Polyflac bottle allows dilution of dry medications and transfer of liquid medication forms into the bottle using a two-way mixing cannula.

Please allow freezing during transportation.

After transportation in subzero temperatures, the drug must be kept at room temperature until completely thawed.

Freezing of the product, provided the bottle is sealed, is not a contraindication to its use.

There have been no clinical studies to evaluate the effect of the drug on the ability to drive vehicles and machinery.

Contraindications

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

Side effects

When the drug is used correctly, adverse reactions are unlikely.

The adverse reactions are listed below in descending order of severity, without indication of frequency of occurrence.

The circulatory system: acidosis, hyperhydration, hypokalemia.

Immune system disorders: hypersensitivity or infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, itching.

General disorders and disorders at the injection site: injection site reactions such as erythema at the injection site, hemorrhage/hematoma at the injection site, burning sensation, urticaria at the injection site, thrombosis or phlebitis at the injection site.

Others: fever, infection at the injection site (in case of violation of the rules of antisepsis).

If the drug is used as a base solution (solvent) for other drugs, the possibility of side effects is determined by the properties of these drugs. In this case, if adverse reactions occur, the administration of the solution should be suspended, the patient’s condition assessed, adequate measures taken, and the remaining solution saved for analysis, if necessary.

Overdose

Symptoms: Nausea, vomiting, diarrhea, spastic abdominal pain, thirst, decreased salivation and lacrimation, increased sweating, fever, tachycardia, increased blood pressure, renal failure, peripheral edema, pulmonary edema, respiratory arrest, headache, dizziness, anxiety, irritability, weakness, muscle cramps and rigidity, generalized seizures, coma and death. Excessive administration of 0.9% sodium chloride solution may cause hypernatremia. Excessive intake of chloride can lead to hyperchloremic acidosis. When 0.9% sodium chloride solution is used as the base solution for dilution and transport of other drugs, the symptoms and complaints of excessive administration are most often related to the properties of the drugs added to the solution. If the solution is unintentionally overinjected, treatment should be discontinued and the patient’s condition evaluated.

Treatment: symptomatic.

Pregnancy use

There are not enough data on the use of the drug in pregnancy and during breastfeeding.

The drug may be used during pregnancy and breastfeeding when the expected benefit to the mother outweighs the possible risk of complications.

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