SODIUM CHLORIDE SERRACLINICS 9 MG/ML (0.9%) SOLUTION FOR INJECTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Sodium chloride Serraclinics 9 mg/ml (0,9%) solution for injection

sodium chloride

Read all of this 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, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

The name of this medicine is Sodium chloride Serraclinics 9 mg/ml (0,9%) solution for injection.

From this point onwards, Sodium chloride Serraclinics 9 mg/ml (0,9%) solution for injection will be referred to as Sodium chloride Serraclinics.

Contents of the leaflet

1. What Sodium chloride Serraclinics is and what it is used for
2. What you need to know before using Sodium chloride Serraclinics
3. How to use Sodium chloride Serraclinics
4. Possible side effects
5. How to store Sodium chloride Serraclinics
6. Contents of the pack and other information

1. What Cloruro de sodio Serraclinics is and what it is used for

Cloruro de sodio Serraclinics is a type of medicine called an electrolyte. It is a sterile saline liquid that can be used in various different circumstances, as it is very similar to the fluids in your body.

The main use of Cloruro de sodio Serraclinics is to dissolve or dilute other medicines so they can be administered as an injection or intravenous infusion (drip) into the veins, muscles, or other body tissues.

Cloruro de sodio Serraclinics may also be used in the preparation for a number of medical and surgical procedures as follows:

• to flush catheters (small devices inserted into your vein to deliver your medicines)
• as a priming solution to fill intravenous cannulas (long tubes connected to your veins)

This is to ensure that no air is injected, for example during hemodialysis (a procedure to clean the blood when you have kidney disease)

• as a priming solution at the beginning and end of blood transfusions without causing damage to blood cells

Cloruro de sodio Serraclinics may also be added to other medicines, such as infusions (drips), for example glucose solutions. In this case, Cloruro de sodio Serraclinics acts as an electrolyte solution to help maintain the proper balance of water levels in different parts of your body.

2. What you need to know before starting to use Sodium Chloride Serraclinics

The doctor or nurse administering this medicine will ask you some questions about your health. They need the following information before administering this medicine for the first time.

Do not use Sodium Chloride Serraclinics

• If you have hypernatremia

• If you have hyperchloremia

Warnings and precautions

Consult your doctor or nurse before starting treatment if:

• You have heart problems
• You have high blood pressure
• You have kidney problems
• You have sodium retention issues

Make sure to read the package leaflets of all your medications, as Sodium Chloride Serraclinics is sometimes added to other medicines to dissolve or dilute them.

Other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines. Also remember to mention any medicines you are taking that do not require a prescription.

It is very important that you tell your doctor if you are taking any of the following medicines:

• Corticosteroids such as cortisone, hydrocortisone, prednisone, prednisolone, betamethasone

Pregnancy and breastfeeding

It is not known whether Sodium Chloride Serraclinics causes problems during pregnancy or breastfeeding.

Since Sodium Chloride Serraclinics is sometimes administered with other medicines, it is important that:

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

Your doctor will advise you whether you should use this medicine.

3. How to use Sodium Chloride Serraclinics

This medicine will usually be administered by a doctor or nurse.

Your doctor or nurse will use the correct amount of Sodium Chloride Serraclinics depending on the intended use.

Your doctor will determine the amount (dose) of medicine you should receive and how long the treatment should last. The dose will depend on the purpose for which Sodium Chloride Serraclinics is being used, for example, to dissolve or dilute another medicine or as a priming solution.

If you use more Sodium Chloride Serraclinics than you should

This medicine is usually administered by a doctor or nurse. If you think you may have received too much of the medicine, inform your doctor or nurse immediately.

Since this medicine comes in a small volume (maximum 20 milliliters per container), it is unlikely that you would receive an excessive amount.

Sodium chloride is sometimes administered together with other medicines, so you must make sure to read the package leaflets for all your medications.

If you forget to use Sodium Chloride Serraclinics

This medicine is usually administered by a doctor or nurse. If you think a dose may have been missed, inform your doctor or nurse.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them. The expected benefit of your medicine is generally greater than the risk of experiencing any harmful adverse effect.

The known adverse effects of Sodium Chloride Serraclinics when used to dissolve and dilute other medicines or when used as a priming solution are excess sodium in the blood, excess chloride in the blood.

Please remember that you may also experience adverse effects related to the other medicines for which Sodium Chloride Serraclinics is used to dissolve or dilute. Make sure to read the package leaflets of all your medicines.

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 via 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 Sodium Chloride Serraclinics

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

Do not use this medicine after the expiry date stated on the plastic container (blister) label after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Use this medicine only if it is a clear, colourless solution. Open and use immediately. Any unused portion of the product should be discarded after opening.

Medicines must not be disposed of via wastewater . Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Sodium Chloride Serraclinics

• The active substance is Sodium Chloride.
• The other component is Water for Injections.

This medicine contains 0.9% w/v (9 mg per ml) of sodium chloride.

Appearance of the product and contents of the container

Sodium Chloride Serraclinics is a clear, colourless liquid free from visible particles.

Each plastic ampoule contains 5 ml (millilitres), 10 ml, or 20 ml of the medicinal product. The 5 ml ampoules are packed in boxes containing 20 or 50 ampoules. The 10 ml ampoules are packed in boxes containing 20, 50, or 100 ampoules. The 20 ml ampoules are packed in boxes containing 20 ampoules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios SERRA PAMIES S.A.
Ctra. Castellvell, 24
43206 REUS (Tarragona)

Manufacturer

Demo S.A.
21st Km National Road Athens-Lamia
14568 Attiki
Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Natriumchlorid Noridem 0,9 % Injektionslösung
Germany: Natriumchlorid Noridem 0,9 % Injektionslösung
Denmark: Natriumchlorid ”Noridem”, solvens til parenteral anvendelse/injektionsvæske, opløsning
Greece: SODIUM CHLORIDE/NORIDEM 0.9% w/v Διαλ?της για παρεντερικ? χ?ση
Spain: Sodium Chloride Serraclinics 9 mg/ml (0.9%) solution for injection
Ireland: Sodium Chloride 0.9% w/v Injection BP
Netherlands: Natriumchloride Noridem 0,9%, oplossing voor injectie en oplosmiddel voor parenteraal gebruik 9 mg/ml
Norway: Natriumklorid Noridem 9 mg/ml injektjonsvæske, oppløsning
Portugal: Cloreto de Sódio Noridem 9 mg/ml Solução injetável
Sweden: Natriumklorid Noridem 9 mg/ml injektionsvätska, lösning
Malta: Sodium Chloride 0.9% w/v Injection BP

Date of the most recent review of this leaflet: 04/2026