PROSPECTO: INFORMATION FOR THE USER

Suero Fisiológico Braun 0.9%

Parenteral solvent

Sodium chloride

Braun Physiological Solution belongs to the group of intravenous medication solutions.

Braun Physiological Solution is used as a transport solution for other compatible medications and for the treatment ofhypontatremias and metabolic alkalosis hypochloremic.

No useSuero Fisiológico Braun:

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

If you experience:

• excessive sodium (hypernatremia) or chloride (hyperchloremia) in the body.
• metabolic acidosis (pH below the normal range).

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Suero Fisiológico Braun.

If you have conditions where sodium intake is restricted, such as heart failure, generalized fluid retention (edema), fluid accumulation in the lungs (pulmonary edema), high blood pressure (hypertension), high blood pressure during pregnancy (eclampsia), or severe kidney insufficiency.

Regular monitoring of serum electrolytes, fluid balance, and acid-base balance is necessary.

When administered subcutaneously, no additives should be added as this would change the isotonicity.

Children

In premature and lactating infants, the administration of sodium chloride should only be given after determining serum sodium levels.

Consider the contraindications related to added medications.

Use of Suero Fisiológico Braun with other medications

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

The administration of sodium chloride accelerates renal excretion of lithium, leading to a decrease in its therapeutic effect.

Administer with caution in patients treated with corticosteroids or adrenocorticotropic hormone, as they may retain water and sodium.

Interactions that may occur are those corresponding to medications that dissolve.

Before mixing with other medications, check the compatibility tables, consider the pH, and control ions.

Pregnancy and lactation

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

Suero Fisiológico Braun can be used when indicated during pregnancy and lactation. Possible interactions are those corresponding to medications that dissolve.

Driving and operating machines

Medications dissolved in physiological serum (sodium chloride 0.9%) may cause adverse effects on driving and operating machines.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose and method of administration depend on the medication to be dissolved in the physiological solution, as well as the patient's age, weight, and clinical conditions.

Before dissolving a medication, it is necessary to check that it is soluble and compatible with the physiological solution.

If you use more Braun Physiological Solution than you should

The signs and symptoms of an overdose may also be related to the nature of the medication added.

In case of overdose or accidental ingestion, administration should be stopped immediately and the patient treated according to symptoms.

If not admitted to a hospital, go to the nearest hospital or consult the Toxicological Information Service. Phone: 91 562 04 20, 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 cause adverse effects, although not everyone will experience them.

If a large amount of the solution is administered, it may increase sodium and chloride levels in the plasma.

The nature of the medication added to this medication will determine the likelihood of any other adverse reaction occurring.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if the solution is cloudy or sedimented (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 drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Braun Physiological Solution

The active principle is:

The other components are: water for injection preparations.

Appearance of the product and contents of the packaging

Braun Physiological Solution is a transparent and colorless solution, presented in plastic ampoules (Mini-Plasco®Basic, Mini-Plasco®Classic, or Mini-Plasco®Connect), of 5, 10 or 20 ml, in containers containing 1, 20 or 100 ampoules and Mini-Plasco®Basic ampoules of 10 ml and 20 ml are presented in a container containing 50 ampoules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

B. Braun Melsungen, AG

Mistelweg 2,

12357 Berlin

Germany

Last review date of this prospectus: November 2019.

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Single-use containers.

Once the container is opened, the product must be used immediately.

Discard any remaining unused content after completing administration.

Only use the solution if the container closure is not damaged and the solution is transparent.

Before mixing the solution with other medications, consider any possible incompatibilities.

When used as a solvent for medications and/or diluent for parenteral solutions, before administration, the osmolarity of the final solution must be checked and, whenever possible, its isotonicity with plasma adjusted.