Sodium chloride 0.9% solution for infusion B. Braun

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fisiológico B. Braun 0,9%

infusion solution

Read the entire leaflet carefully before you start using the medicine

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

This medicine is a sodium chloride solution administered through a vein (intravenous infusion).

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

You will receive it as a source of fluids and electrolytes when:

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

This solution is also used:

• For immediate blood volume replacement after blood loss
• As a vehicle for administering other electrolytes or medicines
• For wound treatment and humidification of wound dressings and packings

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

Do not use Fisiológico 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 diagnosed with significantly increased levels of sodium or chloride in your blood (severe hypernatremia or severe hyperchloremia).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Fisiológico B. Braun 0.9%.

if you have:

• abnormally low levels of potassium in the blood (hypokalemia);
• abnormally high levels of sodium in the blood (hypernatremia);
• abnormally high levels of chloride in the blood (hyperchloremia);
• any medical condition requiring reduced sodium intake, such as heart disease (heart failure), severe kidney disease (severe renal failure), body tissue swelling due to excess water in tissues (generalized edema), fluid in the lungs (pulmonary edema), high blood pressure (hypertension), or eclampsia—a condition occurring during pregnancy characterized by hypertension, seizures, and swelling (edema)—liver disease, or treatment with corticosteroids.

While you are receiving this medicine, your serum electrolyte levels, water balance, and acid-base balance will be monitored periodically.

If rapid infusion of the solution is required, your heart and lung function will be closely monitored.

Your doctor will ensure that your blood sodium levels do not rise too quickly, to avoid brain damage (osmotic demyelination syndrome).

If the solution is used as a vehicle to administer other electrolytes or medicines, your doctor will take into account the safety information of the medicine to be dissolved or diluted in Fisiológico B. Braun 0.9%.

Paediatric population

Newborns or premature newborns may retain excess sodium due to insufficient kidney function. Therefore, repeated infusions of sodium chloride should only be administered by a doctor after determining serum sodium levels.

Other medicines and Fisiológico B. Braun 0.9%

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

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

Pregnancy and breast-feeding

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

Pregnancy

Fisiológico B. Braun 0.9% may be used according to its indications.

Your doctor will pay special attention if you have a specific disorder that can occur during pregnancy and is characterized by hypertension, seizures, and swelling.

Breast-feeding

Since sodium and chloride concentrations are similar to those naturally present in the human body, no harmful effects are expected from the use of this product when used as directed. If necessary, Fisiológico B. Braun 0.9% may be used during breast-feeding.

Driving and using machines

Fisiológico B. Braun 0.9% has no influence on your ability to drive or operate machinery.

3. How to use Fisiológico B. Braun 0.9%

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

Posology

Adults

The volume of medicine you will be given varies depending on your requirements 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, diarrhoea or vomiting, for example, your doctor will replace this additional loss according to the volume and composition of the fluids lost.

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

Close monitoring will be carried out in elderly patients. In elderly patients, it may be necessary to adjust the recommended dose to avoid circulatory or renal problems resulting from hydration.

Exceptionally, if you need urgent replacement of blood volume loss, you may receive this solution rapidly by pressure infusion. In such cases, the utmost care must be taken to expel all air from the container and the line before starting the infusion.

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

Use in children

The doctor will determine the dose for your child on an individual basis.

If you receive more Fisiológico B. Braun 0.9% than you should

An overdose may cause abnormally high levels of fluids, sodium and chloride in your blood, fluid accumulation in the tissues (oedema) and/or high levels of acidic substances in the blood (your blood will become acidic). Early signs of overdose may include thirst, confusion, sweating, headache, fatigue, drowsiness or tachycardia.

Excessively rapid increases in sodium levels may damage your brain (chronic demyelination syndrome).

In such cases, the infusion must be stopped immediately. In addition, diuretics will be provided to increase your urine flow. Continuous monitoring of electrolyte levels in the blood will be performed. Your doctor will prescribe other medications or recommend further measures to normalize 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 at telephone number 915 620 420, indicating the medicine and the amount used.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

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

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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fisiológico 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 packaging. The expiry date refers to the last day of the month indicated.

Do not use this medicine if the solution is cloudy or shows sedimentation (presence of particles at the bottom of the container), or if the container shows any visible signs of damage.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

After dilution or mixing with additives:

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

6. Contents of the container and other information

Composition of Fisiológico 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 component (excipient) is water for injections.

The active substance is:

Appearance of the product and contents of the container

Fisiológico B. Braun 0.9% is an infusion solution that is clear and colorless, supplied in plastic bottles (Ecoflac Plus®) of 50, 100, 250, 500, and 1,000 ml, packed in cartons containing one bottle.

Some pack sizes may not 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 the most recent review of this leaflet: 02/2022.

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

This information is intended for healthcare professionals only:

The increase in serum sodium concentration should not exceed 9 mmol/L/day to avoid the occurrence of osmotic demyelination syndrome. As a general recommendation, a correction rate of 4 to 6 mmol/L/day is reasonable in most cases, although this may vary depending on the patient's condition and concomitant risk factors.