APIROSERUM SODIUM CHLORIDE 2% SOLUTION FOR INFUSION

Patient Information Leaflet

Introduction

Patient Information Leaflet

APIROSERUM SODIUM CHLORIDE 2% solution for infusion

Sodium chloride

Read the entire leaflet carefully before you start using this medicine, because 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 any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What APIROSERUM SODIUM CHLORIDE 2% is and what it is used for
2. What you need to know before using APIROSERUM SODIUM CHLORIDE 2%
3. How to use APIROSERUM SODIUM CHLORIDE 2%
4. Possible side effects
5. Storage of APIROSERUM SODIUM CHLORIDE 2%
6. Package contents and other information

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

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

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

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

Do not use APIROSERUM SODIUM CHLORIDE 2%

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

• Edema (swelling caused by fluid accumulation in body tissues),
• Hypertension (high blood pressure),
• Hyposystolia (reduced heart contraction force),
• Hyperchloremic metabolic 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 (impaired kidney function), 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 carried out under strict monitoring of blood sodium levels.

Use of APIROSERUM SODIUM CHLORIDE 2% with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

This medicine has no influence on the ability to drive or operate machinery.

3. How to use APIROSERUM SODIUM CHLORIDE 2%

APIROSERUM SODIUM CHLORIDE 2% is administered by perfusion (intravenous infusion drop by drop). The dosage will be determined by the physician according to 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 patients

Although there are no clinical experiences suggesting differences in therapeutic response in elderly patients, dosage adjustment should be cautious, starting with the lowest possible dose and assessing potential risks related to other disorders the patient may have.

APIROSERUM SODIUM CHLORIDE 2% must be injected completely or partially once the infusion set is connected to the bottle, to prevent possible contamination.

In case of multiple mixtures, maximum asepsis must be maintained during the addition of medications to intravenous fluids, and such 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.

If these conditions are not met and any symptoms related to adverse effects occur, administration should be discontinued and symptomatic treatment should be initiated.

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

4. Possible adverse effects

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

During the use of hypertonic solutions, the following adverse reactions have been observed, the frequency of which has not been accurately established. These reactions arise from inappropriate use of the medicine, either due to incorrect indication or to inappropriate dosage or administration technique:

• Pulmonary edema and congestive heart failure.

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

• Thrombosis (clot formation inside a blood vessel), phlebitis (inflammation of the wall of a vein), extravasation (leakage of the medicine out of the vein and into the skin). Infusing the solution too rapidly may cause local pain and venous irritation.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of APIROSERUM SODIUM CHLORIDE 2%

Store below 25°C.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.

6. Contents of the pack and other information

Composition of APIROSERUM SODIUM CHLORIDE 2%

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

Milliequivalents/litre: Chloride ion 342 mEq; Sodium ion 342 mEq

Osmolality: 684 mOsmol/litre

pH = 4.5–7.0

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

Appearance of the product and contents of the container

Apiroserum Sodium Chloride 2% is a clear, colourless solution.

Glass bottles containing 250, 500, and 1000 ml.

Clinical packs containing 12 bottles of 250 and 500 ml.

Only certain pack 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 summary of product characteristics was approved in January 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Dosage and administration

Regarding the calculation of 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. Rapid correction should be stopped once life-threatening symptoms have resolved or when a serum sodium concentration of 125–130 mEq/l is reached (or even lower if plasma sodium is below 100 mEq/l), without exceeding an increase of 12 mEq/l in the first 24 hours.

To avoid potential harm from excessive changes, serum sodium concentration should not increase by more than 25 mEq/l during the first 48 hours of treatment.

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

Conc. of Na in 1 litre of infusion – Serum Na

Estimated change in serum Na = ---------------------------------------------------------

Total body water + 1

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

Once the desired correction has been achieved, administration of a non-hypertonic saline solution may be considered.

Paediatric population

Intravenous administration of hypertonic solutions (>0.9%) should only be used for the initial treatment of acute hyponatremia symptoms; maintenance: 3–4 mEq/kg/day; maximum 100–150 mEq/day. In any case, dosage varies widely depending on clinical condition. Replacement should be guided by laboratory values.

Warnings and special precautions

Urine output and sodium levels should be monitored every 2 hours to adjust the infusion regimen accordingly.

Clinical response should be monitored after drug administration, with careful observation of intravascular volume expansion and increases in serum sodium levels (risk of hypernatremia due to overcorrection).

The solution must be administered using sterile equipment and an aseptic technique. The administration set should be primed with the solution to prevent air from entering the system.

An aseptic technique must be used when administering the solution and when preparing mixtures.

Prior to adding medications to the solution or administering concomitantly with other medicinal products, compatibility must be verified.