Label: information for the patient

Fisiológico B. Braun 0.9%

infusion solution

Read the label carefully before starting to use the medication

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

This medication is a sodium chloride solution administered through a vein (intravenous catheter).

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

You will receive it as a fluid and electrolyte supplement when:

• You are experiencing isotonic dehydration (a lack of fluids in the body)
• You are experiencing hypotonic dehydration (a lack of fluids and abnormally low sodium levels in the blood)
• You have low chloride levels in the blood and an abnormally high blood pH (alkalosis hypochloremic)
• You are experiencing sodium loss

This solution is also used:

• For immediate blood volume replacement after blood loss
• As a vehicle to administer other electrolytes or medications
• For wound treatment and humidification of wound dressings and packing

No Physiological Use B.Braun 0.9%:

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

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

Warnings and Precautions

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

If you have:

• Abnormally low levels of potassium in your blood (hypokalemia);
• Abnormally high levels of sodium in your blood (hypernatremia);
• Abnormally high levels of chloride 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 insufficiency), generalized edema due to excess water in tissues, pulmonary edema, high blood pressure (hypertension), or eclampsia, a condition that occurs during pregnancy and is characterized by hypertension, cramps, and edema, liver disease, and corticosteroid treatment.

While taking this medication, your levels of electrolytes in serum, water balance, and acid-base balance will be checked from time to time.

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

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

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

Pediatric Population

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

Other Medications and B. Braun 0.9% Physiological

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications.

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 can cause fluid accumulation in body tissues (edema, hypertension).

Pregnancy and Lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Your doctor will pay special attention if you have a specific condition that may occur during pregnancy and is characterized by hypertension, cramps, and edema.

Lactation

Since the concentrations of sodium and chloride are similar to those present in the human body, no adverse effects are expected from the use of the product if followed as indicated. If necessary, B. Braun 0.9% Physiological may be used during lactation.

Driving and Operating Machines

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

This medication is for intravenous use, or for irrigation or humidification.

Dosage

Adults

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

Daily maximum dose

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

If you present with fever, diarrhea, or vomiting, for example, the doctor will replace the additional loss according to the volume and composition of the lost liquids.

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

A meticulous 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 as a result of hydration.

In exceptional cases, if you need to urgently restore blood volume loss, you may receive this solution quickly through a pressure infusion. In that case, maximum attention will be paid to expelling all air from the container and the pathway before starting the perfusion.

The volume used for humidification or wound irrigation will vary according to actual requirements.

Use in children

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

A overdose may cause you to have abnormally high levels of liquids, sodium, and chloride in your blood, accumulation of liquid in tissues (edema), and/or high levels of acidic substances in your blood (your blood will become acidic). The first signs of an overdose may be thirst, confusion, sweating, headache, fatigue, drowsiness, or tachycardia.

Excessive rapid increase in sodium levels may damage your brain (chronic demyelination syndrome).

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

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

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

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use this medication if the solution is cloudy or if there is sediment (presence of particles at the bottom of the packaging) or if the packaging shows visible signs of deterioration.

Medications should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

After dilution or mixing with additives:

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

Solution Composition of Fisiológico B.Braun 0.9%

The active ingredient is sodium chloride.

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

The other component (excipient) is water for injectable preparations.

The active ingredient is:

Appearance of the product and contents of the packaging

Fisiológico B. Braun 0.9% is a perfusion solution, transparent and colorless, which is packaged in plastic bottles (Ecoflac Plus) of 100, 250, 500, 1,000 ml, in boxes of one bottle.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

B|BRAUN

B. Braun Medical, SA

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for Manufacturing

B. Braun Medical, SA

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

B. Braun Avitum AG

Schwarzenberger Weg 73-79

34212 Melsungen

Germany

Last review date of this leaflet:02/2022.

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices.

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This information is intended solely for doctors or healthcare professionals:

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