SODIUM CHLORIDE B. BRAUN 20% CONCENTRATE FOR INFUSION SOLUTION

Introduction

Package Leaflet: Information for the 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Sodium Chloride B. Braun 20% and what is it used for

Sodium chloride is a concentrated solution for infusion to treat sodium and chloride deficiency. It will be administered after dilution in an infusion solution, through a cannula placed in a vein (intravenous drip).

It will be administered as a salt supplement when:

• you have low levels of sodium or chloride

you have fluid retention with loss of salts

2. Before using Sodium Chloride B. Braun 20%

Do not use Sodium Chloride B. Braun:

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

Warnings and precautions

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

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

.

Be especially careful if you are receiving certain hormones, called corticosteroids or ACTH, as these substances may affect the balance of fluids and salts. While you are receiving this medicine, your doctor will monitor your serum electrolyte levels, water balance, and acid-base balance at all times.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Be especially careful if you suffer from eclampsia, a condition that occurs during pregnancy, with high blood pressure, seizures, and edema.

Using other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Corticosteroids and ACTH may lead to fluid and salt retention, possibly causing edema and high blood pressure. Your doctor should know if you are using or receiving these medicines.

Driving and using machines

Sodium Chloride B. Braun 20% has no influence on the ability to drive and use machines.

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

This medicine will be administered by infusion, intravenously, 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, in particular 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 the section "If you use more Sodium Chloride B. Braun 20% than you should").

Follow exactly the instructions for using Sodium Chloride Braun indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you use more Sodium Chloride B. Braun 20% than you should

Signs of overdose

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

Rapid infusion can cause volume overload. It may cause fluid accumulation in the limbs or water in the lungs, as well as high blood pressure. Diarrhea and increased urine flow due to abnormally high salt concentration in the blood may also occur.

Excessive rapid increase in sodium levels can affect the brain (chronic demyelination syndrome).

Actions to consider in case of overdose

In these cases, the infusion should be stopped immediately. Additionally, diuretics will be administered to increase urine flow. Continuous monitoring of blood electrolyte levels will be performed. Your doctor will prescribe other medicines or recommend other measures to normalize electrolyte levels, water balance, and acid-base balance.

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

4. Possible side effects

Like all medicines, Sodium Chloride B. Braun 20% can cause side effects, although not everybody gets them.

Solutions with a high salt content may cause irritation or inflammation in the vein where the cannula is placed for infusion.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side 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 are required.

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

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

The contents of the ampoules should be used immediately after opening. Once the packaging is opened, discard the unused portion of the solution.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sodium Chloride B. Braun 20%

The active substance is sodium chloride.

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

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

The other components are water for injectable preparations.

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

Appearance of the product and contents of the pack

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer:

This leaflet was approved inJuly 2016

Detailed information on this medicine is available on the website ofthe Spanish Agency for Medicines and Health Products.http//www.aemps.gob.es/

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This information is intended onlyfor healthcare professionals:

The possibility of incompatibilities when mixed with other medicines should be taken into account.

The doctor will decide on the use of infusions mixed with other solutions.