Prospecto:Information for the User

APIROSERUM SODIUM CHLORIDE 2% solution for infusion

Sodium Chloride

Read this prospect carefully before starting touse this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult yourdoctor or nurse.
• If you experience adverse effects,consult your doctor or nurse,eveniftheydo not appear in this prospect. See section 4.

1.What is APIROSERUM SODIUM CHLORIDE 2% and what is it used for

2.What you need to knowbeforestarting touse APIROSERUM SODIUM CHLORIDE 2%

3.How to use APIROSERUM SODIUM CHLORIDE 2%

4.Possible adverse effects

5Storage of APIROSERUM SODIUM CHLORIDE 2%

6.Contents of the package and additional information

APIROSERUM SODIUM CHLORIDE 2% is a restorative solution, for intravenous use,mainly indicated in the treatment of the following disorders caused by large electrolyte depletions (loss of salts), without water loss:

• Symptoms of water intoxication.
• Relative hyponatremias (decrease in the sodium/water ratio, due to hydration) when symptoms of water intoxication (seizures, vomiting, severe headaches) are present and spontaneous water elimination cannot be awaited.
• Hyperkalemias (elevated potassium levels in the blood) associated with hyponatremia (low sodium levels in the blood), when administration of large volumes of fluid is contraindicated.

Do not use APIROSERUM SODIUM CHLORIDE 2%

In situations where the administration of a hypertonic solution may worsen the clinical situation by increasing fluid, such as:

• Edema (swelling caused by accumulation of liquids in the tissues of your body),
• Hypertension (elevated blood pressure),
• Hyposystole (decreased force of contraction of the heart),
• Metabolic acidosis with hyperchloremia (excess of acid in the metabolism).

Warnings and precautions

Consult your doctor or nurse before starting to use APIROSERUM SODIUM CHLORIDE 2%.

If you havecongestive heart failure (heart failure with pulmonary edema), renal dysfunction (poor kidney function), preeclampsia (elevated blood pressure caused by pregnancy) or other alterations associated with sodium retention.

Children

The use ofAPIROSERUM SODIUM CHLORIDE 2%in children should be carried out under strict control of blood sodium levels.

Use of APIROSERUM SODIUM CHLORIDE 2% with other medications

Inform your doctor if you areusing, have used recentlyor may need to use any other medication.

APIROSERUMCLORURO SÓDICO 2%may decrease the therapeutic effect of lithium salts (antidepressant medication).

Pregnancy,breastfeedingand fertility

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consultyour doctor before using this medication.

Driving and operating machines

The influence of this medication on the ability to drive and operate machines is nil.

APIROSERUM SODIUM CHLORIDE 2% is administered by infusion (intravenous drip). The dosage will be determined by the doctor based on the patient's condition.

Use in children and adolescents

The administration of APIROSERUM SODIUM CHLORIDE 2% in children should only be carried out for the initial treatment of acute symptoms of hyponatremia (low sodium levels in the blood).

Use in elderly people

Although there are no clinical experiences that suggest differences in therapeutic response in the elderly, the dose adjustment should be cautious, starting with the lowest possible dose and evaluating the possible risks related to other disorders that may be present.

APIROSERUM SODIUM CHLORIDE 2% should be injected completely or partially once the injection equipment is connected to the vial, to prevent possible contaminations.

In the case of multiple mixtures, maximum asepsis should be maintained during the addition of medications to intravenous use liquids, and these mixtures should be used within 6 hours of preparation.

If you use more APIROSERUM SODIUM CHLORIDE 2% than you should

Given the nature of the product, if its indication and administration are correct and controlled, there is no risk of intoxication.

In the event that these requirements are not met, if you present any symptoms derived from adverse effects, the administration will be suspended and symptomatic treatment will be sought.

If you have any other doubts about the use of this medication , ask your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of hypertonic solutions, the following adverse reactions have been observed, whose frequency has not been established with precision, which derive from the improper use of the medication, either by incorrect indication or by using an inappropriate dosage or administration technique:

-Pulmonary edema and congestive heart failure.

-Hypervolemia (abnormal increase in plasma volume in the body), hypernatremia (elevated sodium levels in blood), decrease in serum electrolytes, overhydration, hypokalemia (low potassium levels in blood).

-Thrombosis (clot in the interior of a blood vessel), phlebitis (inflammation of the wall of a vein), extravasation (escape of the medication outside the vein and into the skin).Rapid perfusion may generate local pain and venous irritation.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus.www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Store below 25?C.

Keepthis medicationout of the sight andreach of children.

Do not usethis medicationafter the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Composition of APIROSERUM SODIUM CHLORIDE 2%

• The active principle is sodium chloride. Each 100 ml of solution contains2 gof sodium chloride.

Milliequivalents per liter: Chloride ion 342 mEq; Sodium ion 342 mEq

Osmolarity: 684 mOsmol/liter

pH = 4.5-7.0

The other components(excipients)arewater for injectable preparations, hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the container

Apiroserum Sodium Chloride 2% is a transparent and colorless solution.

Glass bottles with 250, 500 and 1000 ml.

Clinical containers with 12 bottles of 250 and 500 ml.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fresenius Kabi España S.A.U.

Torre Mapfre – Vila Olímpica

Marina 16-18,08005-Barcelona (Spain)

Responsible for manufacturing:

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

I - 37063 Isola della Scala (Verona)

This leaflet was approved in January 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

Dosage

In relation to the calculation of the volume and rate of administration of a hypertonic sodium chloride solution, in patients with severe symptoms, correction may be initiated at 1-2 mEq/l/hour, recommending stopping rapid correction when symptoms threatening the patient's life cease, or when a serum sodium concentration of 125-130 mEq/l (or lower if the plasma sodium value is less than 100 mEq/l) is reached, without exceeding 12 mEq/l in the first 24 hours.

To avoid the possible damage that an excessive change can cause, the sodium concentration should not exceed 25 mEq/l during the first 48 hours of treatment.

The rate of correction of hyponatremia should be calculated using the following formula:

Sodium concentration in 1 liter of infusion – Serum sodium

Change in serum sodium concentration = ---------------------------------------------------------

Total body water + 1

Clinical use: Estimated effect of 1 liter of solution on serum sodium

Once correction is achieved, it may be evaluated whether to administer non-hypertonic saline solution.

Pediatric population

Intravenous administration of hypertonic solutions (>0.9%) should only be carried out for the initial treatment of acute symptoms of hyponatremia; maintenance 3-4 mEq/Kg/day; maximum 100-150 mEq/day. In any case, the dose varies greatly depending on the clinical condition. Restoration is determined by laboratory values.

Warnings and special precautions

The volume of urine and sodium should be monitored every2 hoursto modify the infusion regimen.

The clinical response should be monitored after administration of the drug, watching for the increase in intravascular volume and the elevation of sodium levels (hypernatremia due to over-correction).

The solution should be administered through a sterile equipment and an aseptic technique. The equipment should be primed with the solution to prevent air entry into the system.

When administering the solution and in case of mixtures, an aseptic technique should be used.

Before adding medications to the solution or administering simultaneously with other medications, it should be checked that there are no incompatibilities.