Package Leaflet: Information for the user

Sodium ChlorideSerraclinics9 mg/ml (0.9%) injectable solution

Sodium Chloride

Read 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 are the parent of a child who is going to be given this medicine, read the leaflet replacing "you" with "your child" throughout the leaflet.
  • If you have any doubts, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The name of this medicine is Sodium ChlorideSerraclinics9 mg/ml (0.9%) injectable solution.

From now on, Sodium Chloride Serraclinics 9 mg/ml (0.9%) injectable solution will be referred to as Sodium Chloride Serraclinics.

1. What isSodium Chloride Serraclinicsand 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. Storage of Sodium Chloride Serraclinics

6. Contents of the pack and additional information

Sodium Chloride Serraclinics is a type of medication 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 Sodium Chloride Serraclinics is to dissolve or dilute other medications so that they can be administered as an injection or infusion (drip) into the veins, muscles, or other tissues of the body.

Sodium Chloride Serraclinics can also be used to prepare a series of medical and surgical procedures in the following way:

• to clean catheters (small devices that are inserted into your vein to inject your medications)
• as a priming solution to fill intravenous cannulas (long tubes that are connected to your veins)

This is to ensure that air is not injected, for example during hemodialysis (a procedure to clean the blood when you have a kidney disease)

• as a priming solution at the beginning and end of blood transfusions without damaging the blood cells

Sodium Chloride Serraclinics can also be added to other medications, such as infusions (drips), for example to glucose solutions. In this case, Sodium Chloride Serraclinics acts as an electrolyte solution to help maintain the correct balance of water levels in different parts of your body.

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

Do not use Serraclinics Sodium Chloride

• If you have hypernatremia

• If you have hyperchloremia

Warnings and precautions

Inform your doctor or nurse before starting treatment if:

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

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

Using Serraclinics Sodium Chloride with other medications

Inform your doctor about any medication you are taking or have taken recently. Also, remember any medication you are taking that does not require a prescription.

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

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

Pregnancy and breastfeeding

No adverse effects of Serraclinics Sodium Chloride on pregnancy or breastfeeding have been reported.

As Serraclinics Sodium Chloride is sometimes administered with other medications, it is essential that:

Your doctor will indicate whether you should use this medication.

A healthcare professional, such as a doctor or nurse, will typically administer this medication.

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

Your doctor will decide the amount (dose) of medication you should receive and for how long. The dose will depend on the intended use of Serraclinics Sodium Chloride, such as dissolving or diluting another medication or as a priming solution.

If you use more Serraclinics Sodium Chloride than you should

This medication is usually administered by a healthcare professional. If you think you have received too much medication, inform your doctor or nurse immediately.

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

Sodium Chloride may be administered with other medications, so be sure to read the labels of all your medications.

If you forgot to use Serraclinics Sodium Chloride

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

If you have any other questions about using this product, ask your doctor, nurse, or pharmacist.

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.The expected benefit of your medication will generally be greater than the risk of experiencing any harmful adverse effect.

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

Remember that you may also experience adverse effects related to the other medications for whichSerraclinics Sodium Chlorideis used to dissolve or dilute. Make sure to read the prospectuses of all your medications.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and on the plastic container label (ampoule) after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Use this medication only if it is a transparent and colorless liquid. Open it and use it immediately. The unused product portion must be discarded after opening.

Dispose of any remaining medication to your doctor, nurse, or pharmacist. Medications should not be thrown down the drain or in the trash.Ask your pharmacisthow to dispose ofthecontainers and themedications that you no longerneed. This way, you will help protect the environment..

Serraclinics Sodium Chloride Composition

• The active ingredient is Sodium Chloride.
• The other component is Water for injection preparations.

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

Product Appearance

Serraclinics Sodium Chloride is a transparent and colorless liquid.

Package Contents

Each plastic ampoule contains 5 ml (milliliters), 10 ml, or 20 ml of the medicine.

The 5 ml ampoules are packaged in boxes with 20 or 50 ampoules.

The 10 ml ampoules are packaged in boxes with 20, 50, or 100 ampoules.

The 20 ml ampoules are packaged in boxes with 20 ampoules.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for Manufacturing

Demo S.A.

21st Km National Road Athens-Lamia

14568 Athens

Greece.

This medicine is authorized in the member states of the European Economic Areawith the following names:

AT:Natriumchlorid Noridem Injection Solution or Solvent for Parenteral UseDE:Natriumchlorid Noridem 0.9% Injection Solution

DK:Natriumchlorid “Noridem”, solvent for parenteral use/injection solution, 9mg/mL

EL:SODIUM CHLORIDE 0,9%/NORIDEM,Διαλύτηςγιαπαρεντερικήχρήση9mg/mL

ES:Cloruro de sodio Serraclinics 9 mg/ml (0,9%) injectable solution

IE:Sodium Chloride 0.9% (w/v) Injection BP

NL:Natriumchloride Noridem 0.9%, solution for injection and solvent for parenteral use 9mg/mL

NO:Natriumklorid Noridem 9mg/mL injection solution, solution “Noridem”

PT:Cloreto de sódio Noridem 9 mg/ml Injectable Solution

SE:Natriumklorid Noridem 9mg/mL injection fluid, solution

UK:Sodium Chloride 0.9% (w/v) Injection BP

Last reviewed date of this leaflet: 04/2018

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