APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION

Introduction

Leaflet:information for the user

APIROSERUM SODIUM CHLORIDE 2% solution for infusion

Sodium chloride

Read the entire leaflet carefully before starting touse this medicine,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is APIROSERUM SODIUM CHLORIDE 2% and what is it used for
2. What you need to know before starting to use APIROSERUM SODIUM CHLORIDE 2%
3. How to use APIROSERUM SODIUM CHLORIDE 2%
4. Possible side effects

5 Storage of APIROSERUM SODIUM CHLORIDE 2%

1. Package contents and additional information

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

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

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

2. What you need to know before starting to use APIROSERUM SODIUM CHLORIDE 2%

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 fluid accumulation in the body's tissues),
• Hypertension (high blood pressure),
• Hiposistolia (decreased heart contraction force),
• Metabolic hyperchloremic acidosis (excess acid in metabolism).

Warnings and precautions

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

If you have congestive heart failure (heart failure with pulmonary congestion), renal dysfunction (kidney malfunction), preeclampsia (high blood pressure caused by pregnancy), or other conditions associated with sodium retention.

Children

The use of APIROSERUM SODIUM CHLORIDE 2% in children should be done under strict control of blood sodium levels.

Use of APIROSERUM SODIUM CHLORIDE 2% with other medicines

Tell your doctor if you are using, have recently used, or may need to use any other medicine.

APIROSERUM SODIUM CHLORIDE 2% may decrease the therapeutic effect of lithium salts (antidepressant medication).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is nil.

3. How to use APIROSERUM SODIUM CHLORIDE 2%

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 done for the initial treatment of acute symptoms of hyponatremia (low sodium levels in the blood).

Use in elderly patients

Although there are no clinical experiences that suggest differences in therapeutic response in the elderly, the dose adjustment should be careful, starting with the lowest possible dose and evaluating the potential risks associated with other conditions that the patient may have.

APIROSERUM SODIUM CHLORIDE 2% should be injected totally or partially once the injector equipment is connected to the vial, to prevent possible contamination.

In case of multiple mixtures, maximum asepsis should be maintained during the addition of medicines to intravenous fluids, 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 case these requirements are not met, if you experience any symptoms derived from side effects, the administration will be suspended and symptomatic treatment will be used.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

During the period of use of hypertonic sera, the following adverse reactions have been observed, whose frequency cannot be established with precision, which are derived from the inadequate use of the medicine, either due to incorrect indication or inadequate dosage or administration technique:

• Pulmonary edema and congestive heart failure.

• Hyperolemia (abnormal increase in plasma volume in the body), hypernatremia (high sodium levels in the blood), decrease in serum electrolytes, overhydration, hypokalemia (low potassium levels in the blood).

• Thrombosis (blood clot in a blood vessel), phlebitis (inflammation of the vein wall), extravasation (leakage of the medicine out of the vein and into the skin). Rapid infusion can cause local pain and venous irritation.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of APIROSERUM SODIUM CHLORIDE 2%

Store below 25°C.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date shown on the package after "CAD". The expiration date is the last day of the month indicated.

6. Package contents and additional information

Composition of APIROSERUM SODIUM CHLORIDE 2%

• The active ingredient is sodium chloride. Each 100 ml of solution contains 2 g of sodium chloride.

Miliequivalents/liter: Chloride ion 342 mEq; Sodium ion 342 mEq

Osmolality: 684 mOsmol/liter

pH = 4.5-7.0

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

Appearance of the product and package contents

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

Glass vials with 250, 500, and 1000 ml.

Clinical packages with 12 vials of 250 and 500 ml.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Fresenius Kabi España S.A.U.

Torre Mapfre – Vila Olímpica

Marina 16-18, 08005-Barcelona (Spain)

Manufacturer:

Fresenius Kabi Italia S.r.l.

Via Camagre, 41/43

I - 37063 Isola della Scala (Verona)

This leaflet was approved in January 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

Dosage

Regarding the calculation of the volume and rate of administration of a hypertonic sodium chloride solution, in patients with severe symptoms, correction can start at 1-2 mEq/l/hour, and it is recommended to stop rapid correction when life-threatening symptoms cease or when a serum concentration of 125-130 mEq/l (or even lower if the plasma sodium value is below 100 mEq/l) is reached, without exceeding 12 mEq/l in the first 24 hours.

To avoid possible damage that 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:

Conc. of Na in 1 liter of perfusion – Na serum

Change in serum Na concentration = ---------------------------------------------------------

Total body water + 1

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

Once correction is achieved, the need to administer non-hypertonic saline solution can be assessed.

Pediatric population

Intravenous administration of hypertonic solutions (>0.9%) should only be done 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. The restitution is determined by laboratory values.

Special warnings and precautions

Urinary volume and sodium should be monitored every 2 hours to modify the infusion regimen.

Clinical response to the administration of the medicine should be monitored, watching for increased intravascular volume and elevated sodium levels (hypernatremia due to overcorrection).

The solution should be administered using a sterile equipment and 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, aseptic technique should be used.

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