FISIOLOGICO B. BRAUN 0.9% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Physiological B. Braun 0.9%

Solution for Infusion

Read all of this leaflet carefully before you start using this medicine

• Keep this leaflet, as 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 signs of illness 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 pack:

1. What is Physiological B. Braun 0.9% and what is it used for
2. What you need to know before you use Physiological B. Braun 0.9%
3. How to use Physiological B. Braun 0.9%
4. Possible side effects
5. Storage of Physiological B. Braun 0.9%
6. Contents of the pack and other information

1. What is Physiological B. Braun 0.9% and what is it used for

This medicine is a sodium chloride solution that is administered to you through a vein (intravenous drip).

It contains sodium chloride at a concentration similar to that of the salts in your blood.

You will receive it as a supply of fluids and salts when:

• You have a lack of body fluids (isotonic dehydration)
• You have a lack of body fluids and your blood sodium level is abnormally low (hypotonic dehydration)
• You have low blood chloride levels and an abnormally high blood pH (hypochloremic alkalosis)
• You have a loss of sodium

This solution is also used:

• For immediate replacement of blood volume after you have lost blood
• As a vehicle for administering other electrolytes or medications
• For the treatment of wounds and humidification of wound dressings and wound plugs

2. What you need to know before using Physiological B. Braun 0.9%

Do not use Physiological B. Braun 0.9%:

if you are allergic to the active substance or any of the other components of this medicine (listed in section 6).

• if you have too much water in your body (hyperhydration);
• if you have been told that you have a significant increase in sodium or chloride in your blood (severe hypernatremia or hyperchloremia).

Warnings and precautions

Talk to your doctor or pharmacist before you start using Physiological B. Braun 0.9%.

if you have:

• abnormally low potassium levels in your blood (hypokalemia);
• abnormally high sodium levels in your blood (hypernatremia);
• abnormally high chloride levels in your blood (hyperchloremia);
• any disease where you need to reduce your sodium intake, such as heart disease (heart failure), severe kidney disease (severe renal failure), swelling of body tissues due to excess water (generalized edema), fluid in the lungs (pulmonary edema), high blood pressure (hypertension), or eclampsia, a disease that occurs during pregnancy and is characterized by high blood pressure, seizures, and swelling.

While you are taking this medicine, your serum electrolyte levels, water balance, and acid-base balance will be checked from time to time.

In case a rapid infusion of the solution is necessary, your heart and lung function will be monitored.

Your doctor will make sure that your blood sodium levels do not increase too quickly to avoid brain damage (osmotic demyelination syndrome).

If the solution is used as a vehicle for administering other electrolytes or medications, your doctor will take into account the safety information of the medication to be dissolved or diluted in Physiological B. Braun 0.9%.

Pediatric population

Newborns or premature infants may retain excess sodium due to insufficient kidney function. Therefore, your doctor will be the only one to perform repeated infusion of sodium chloride after determining the serum sodium level.

Other medicines and Physiological B. Braun 0.9%

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

Your doctor will pay special attention if you are taking or receiving medications that cause sodium retention (e.g., corticosteroids or non-steroidal anti-inflammatory drugs), as these may cause fluid accumulation in body tissues (edema, hypertension).

Pregnancy and breastfeeding

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

Pregnancy

Physiological B. Braun 0.9% can be used as indicated.

Your doctor will pay special attention if you have a specific disorder that may occur during pregnancy, characterized by high blood pressure, seizures, and swelling.

Breastfeeding

Since the concentrations of sodium and chloride are similar to those present in the human body, no harmful effects are expected from the use of the product if the instructions are followed. If necessary, Physiological B. Braun 0.9% can be used during breastfeeding.

Driving and using machines

The influence of Physiological B. Braun 0.9% on your ability to drive and use machines is negligible.

3. How to use Physiological B. Braun 0.9%

This medicine is for intravenous use, or for washing or humidification.

Dosage

Adults

The volume of medicine that will be administered to you varies depending on your needs for water and salts (electrolytes).

Maximum daily dose

You will be administered a maximum of 40 ml per kilogram of body weight per day. This means you will receive up to 6 mmol of sodium per kilogram of body weight per day.

If you have fever, diarrhea, or vomiting, for example, your doctor will replace the additional loss according to the volume and composition of the lost fluids.

The rate of administration will depend on your needs for water and salts (electrolytes).

A thorough follow-up will be performed in elderly patients. In elderly patients, it may be necessary to adjust the indicated dose to avoid circulatory or renal problems due to hydration.

Exceptionally, if you need to replace blood volume urgently, you may receive this solution rapidly through a pressure infusion. In this case, the utmost attention will be paid to expelling all air from the container and the infusion line before starting the infusion.

The volume used for humidification or wound washing varies according to the actual requirements.

Use in children

Your doctor will determine the dose for your child individually.If you receive more Physiological B. Braun 0.9% than you should

An overdose may cause you to have abnormally high levels of fluids, sodium, and chloride in your blood, fluid accumulation in tissues (edema), and/or high levels of acidic substances in your blood (your blood will become acidified). The first signs of overdose may be thirst, confusion, sweating, headache, fatigue, drowsiness, or rapid heart rate.

Rapidly increasing sodium levels can damage your brain (osmotic demyelination syndrome).

In these cases, the infusion of the solution should be stopped immediately. Additionally, you will be given diuretics to increase your urine flow. Your serum electrolyte levels will be continuously monitored. Your doctor will prescribe other medications or recommend other measures to normalize your electrolyte levels, water balance, and acid-base balance.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medicine and the amount used.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

No side effects are expected from the use of the product if the instructions are followed.

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 and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Physiological B. Braun 0.9%

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month stated.

Do not use this medicine if the solution is turbid or sedimented (presence of particles at the bottom of the container) or if the container shows visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Dispose of the container and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

After dilution or mixing with additives:

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not exceed 24 hours at 2°C-8°C.

6. Contents of the pack and other information

Composition of Physiological B. Braun 0.9%

The active substance is sodium chloride.

Each 1,000 ml of solution contains 9.0 g of sodium chloride.

The other ingredient (excipient) is water for injections.

The active substance is:

Appearance of the product and pack contents

Physiological B. Braun 0.9% is a solution for infusion, clear and colorless, presented in plastic bottles (Ecoflac Plus) of 100, 250, 500, 1,000 ml, in boxes of one bottle.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

B|BRAUN

• Braun Medical, SA

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

• Braun Medical, SA

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

• Braun Avitum AG

Schwarzenberger Weg 73-79

34212 Melsungen

Germany

Date of last revision of this leaflet:02/2022.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products.

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This information is intended only for healthcare professionals:

The increase in serum sodium volume should not exceed 9 mmol/L/day to avoid the onset of osmotic demyelination syndrome. As a general recommendation, a correction speed of between 4 and 6 mmol/L/day is reasonable in most cases, although this varies depending on the patient's condition and simultaneous risk factors.