SODIUM CHLORIDE SERRACLINICS 9 mg/ml (0.9%) INJECTABLE SOLUTION

Introduction

Leaflet: Information for the user

Sodium ChlorideSerraclinics9 mg/ml (0.9%) injectable solution

Sodium Chloride

Read the entire leaflet carefully before starting to use this medicine, as 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

The name of this medicine is Sodium Chloride Serraclinics 9 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.

Contents of the leaflet

1. What is Sodium Chloride Serraclinics and what is it used for
2. What you need to know before starting to use Sodium Chloride Serraclinics
3. How to use Sodium Chloride Serraclinics
4. Possible side effects
5. Storage of Sodium Chloride Serraclinics
6. Package contents and additional information

1. What is Sodium Chloride Serraclinics and what is it used for

Sodium Chloride 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 Sodium Chloride Serraclinics is to dissolve or dilute other medicines 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 for the preparation of a series of medical and surgical procedures in the following ways:

• to clean catheters (small devices that are inserted into your vein to inject your medicines)
• as a priming solution to fill intravenous cannulas (long tubes that are 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 damaging blood cells

Sodium Chloride Serraclinics can also be added to other medicines, 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.

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

The doctor or nurse who administers this medicine to you will ask you some questions about yourself. They need the following information before administering this medicine to you for the first time.

Do not useSodium Chloride Serraclinics

• If you have hypernatremia

• If you have hyperchloremia

Warnings and precautions

Tell 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 leaflets of all your medicines, as Sodium Chloride Serraclinics is sometimes added to other medicines to dissolve or dilute them.

Using Sodium Chloride Serraclinics with other medicines

Tell your doctor about any medicine you are taking or have taken recently. Also, remember any medicine 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 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:

• You inform your doctor if you are pregnant or think you may be pregnant.
• You inform your doctor if you are breastfeeding a child.

Your doctor will indicate whether you should use this medicine.

3. How to use Sodium Chloride Serraclinics

It will normally be a doctor or nurse who administers this medicine to you.

Your doctor or nurse will use the correct amount of Sodium Chloride Serraclinics depending on what it is being used for.

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

If you use more Sodium Chloride Serraclinics than you should

Normally, this medicine will be administered to you by a doctor or nurse. If you think you may have received too much 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 will receive an excessive amount of it.

Sodium Chloride is sometimes administered with other medicines, so you should make sure to read the leaflets of all your medicines.

If you forget to use Sodium Chloride Serraclinics

Normally, this medicine will be administered to you by a doctor or nurse. If you think you may have missed a dose, inform your doctor or nurse.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The expected benefit of your medicine will generally be greater than the risk of experiencing any harmful side effect.

The known side 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.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect 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 Sodium Chloride Serraclinics

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the carton and on the label of the plastic container (ampoule) after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Use this medicine only if it is a clear and colorless liquid. Open and use it immediately. The unused part of the product must be discarded after opening.

Return any remaining medication to your doctor, nurse, or pharmacist. Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Sodium Chloride Serraclinics

• The active ingredient 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

Sodium Chloride Serraclinics is a clear 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 of 20 or 50 ampoules.

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

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

Not all 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 Athens

Greece.

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

AT: Natriumchlorid Noridem Injektionslösung oder Lösungsmittel zur Herstellung von Parenteralia

DE: Natriumchlorid Noridem 0.9% Injektionslösung

DK: Natriumchlorid “Noridem”, solvens til parenteral anvendelse/injektionsvæske, opløsning 9mg/mL

EL: SODIUM CHLORIDE 0,9%/NORIDEM, Διαλ?της για παρεντερικ? χρ?ση 9mg/mL

ES: Cloruro de sodio Serraclinics 9 mg/ml (0,9%) solución inyectable

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

NL: Natriumchloride Noridem 0.9%, oplossing voor injectie en oplosmiddel voor parenteraal gebruik 9mg/mL

NO: Natriumklorid Noridem 9mg/mL injektjonsvæske, oppløsning "Noridem"

PT: Cloreto de sódio Noridem 9 mg/ml Solução injectável

SE: Natriumklorid Noridem 9mg/mL injektionsvätska, lösning

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

Date of the last revision of this leaflet: 04/2018

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.es/