SODIUM CHLORIDE B. BRAUN 20% CONCENTRATE FOR SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient user

Sodium Chloride B. Braun 20% concentrate for solution for infusion

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 or pharmacist.
• This medicine has been prescribed for you only; do not give it 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Sodium Chloride B. Braun 20% is and what it is used for
2. What you need to know before using Sodium Chloride B. Braun 20%
3. How to use Sodium Chloride B. Braun 20%
4. Possible side effects
5. How to store Sodium Chloride B. Braun 20%
6. Contents of the pack and other information

1. What Cloruro de Sodio B. Braun 20% is and what it is used for

Sodium chloride is a concentrated solution for infusion used to treat deficiencies of sodium and chloride. It will be administered after dilution in an infusion solution through an intravenous cannula (intravenous infusion).

It will be given to you as an electrolyte supplement when:

• you have low levels of sodium or chloride

you have fluid retention with loss of electrolytes

2. Before using Sodium Chloride B. Braun 20%

Do not use Sodium Chloride B. Braun 20%:

• if you are allergic (hypersensitive) to sodium chloride or to any of the other components of this medicine (listed in section 6).
• if you have high levels of sodium or chloride in your blood

Warnings and precautions

Consult your doctor or pharmacist before using Sodium Chloride B. Braun 20% if you have:

• low levels of potassium in the blood (hypokalemia)
• heart failure
• swelling of the limbs due to excess fluid in body tissues (generalized edema)
• fluid in the lungs (pulmonary edema)
• high blood pressure (hypertension)
• eclampsia, a condition occurring during pregnancy characterized by high blood pressure, seizures, and edema
• severe kidney failure
• abnormally high levels of acidic substances in the blood (acidosis)

.

Take special care if you are receiving certain hormones called corticosteroids or ACTH, as these substances may affect fluid and electrolyte balance. While receiving this medicine, serum electrolyte levels, fluid balance, and acid-base status should be monitored regularly.

Pregnancy and breastfeeding

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

Take particular care if you suffer from eclampsia, a condition occurring during pregnancy characterized by high blood pressure, seizures, and edema.

Use with other medicines

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

Corticosteroids and ACTH may cause fluid and salt retention, possibly leading to edema and elevated blood pressure. Therefore, your doctor must be aware if you are taking or receiving these medications.

Driving and using machines

Sodium Chloride B. Braun 20% has no influence on the ability to drive or operate machinery.

3. How to use Sodium Chloride B. Braun 20%

This medicine will be administered by intravenous infusion and diluted in the appropriate solution.

Your doctor will determine the most suitable dose for you. The concentration depends on the patient's age, weight, and clinical condition, particularly the sodium level and hydration status.

If your sodium levels have been chronically low, your doctor will administer Sodium Chloride B. Braun at a slower infusion rate to avoid brain damage (see also section “If you use more Sodium Chloride B. Braun 20% than you should”).

Always follow exactly the instructions for use of Sodium Chloride B. Braun provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you use more Cloruro de Sodio B. Braun 20% than you should

Signs of overdose

If you are given more Sodium Chloride than you should, it may cause an abnormal increase in your body water content, elevated levels of sodium and chloride in the blood, and your blood may become much more concentrated than normal. Acidic substances may accumulate in your blood.

A rapid infusion may cause volume overload. This could lead to fluid accumulation in the limbs or fluid in the lungs, as well as high blood pressure. Diarrhea and increased urine flow may also occur due to an abnormally high salt concentration in the blood.

A too rapid increase in sodium levels may affect your brain (chronic demyelination syndrome).

Actions to consider in case of overdose

In such cases, the infusion must be stopped immediately. In addition, diuretics will be administered to increase your urine flow. Your blood electrolyte levels will be closely monitored. Your doctor will prescribe other medications or recommend further measures to normalize electrolyte levels, water balance, and acid-base balance.

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

4. Possible adverse effects

Like all medicines, Clorodium Sodium B. Braun 20% may cause adverse effects, although not everyone experiences them.

Solutions with a high salt content may cause irritation or inflammation of the vein where the cannula for infusion has been inserted.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sodium Chloride B. Braun 20%

Keep out of the sight and reach of children.

No special storage conditions required.

Do not use Sodium Chloride B. Braun 20% after the expiry date stated on the container (after EXP). The expiry date refers to the last day of the month indicated.

Do not use this medicine if the solution appears cloudy or discolored, if you notice particles in the solution, or if the ampoule and closure are damaged.

The contents of the ampoules must be used immediately after opening. After opening, any unused portion of the solution should be discarded.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Sodium Chloride B. Braun 20%

The active substance is sodium chloride.

1 ml of concentrate for infusion solution contains 200 mg of sodium chloride.

1 ml of concentrate for infusion solution contains 3.4 mmol of sodium and 3.4 mmol of chloride.

The other component is water for injections.

The theoretical osmolarity is 6,800 mOsmol/l and the pH is 4.5-7.0.

Appearance of the medicinal product and contents of the pack

Sodium Chloride B. Braun 20% is an infusion solution presented in 10 ml polyethylene ampoules (Miniplasco). It is available in packs containing 1 ampoule, 20 ampoules and 100 ampoules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer:

This patient information leaflet was approved in July 2016

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products: http://www.aemps.gob.es/

This information is intended exclusively for physicians or healthcare professionals:

The possibility of incompatibilities occurring when mixed with other medicinal products should be taken into account.

The physician will decide on the use of infusions combined with other solutions.