PHYSIOLOGICAL SERUM BRAUN 0.9% SOLVENT FOR PARENTERAL USE

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Physiological Serum Braun 0.9%

Parenteral use solvent

Sodium chloride

Contents of the package leaflet:

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

1. What is Physiological Serum Braun and what is it used for

Physiological Serum Braun belongs to the group of intravenous solution medicines.

Physiological Serum Braun is used as a transport solution for other compatible medicines and for the treatment of hyponatremia and hypochloremic metabolic alkalosis.

2. What you need to know before you start using Physiological Serum Braun

Do not usePhysiological Serum Braun:

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

If you have:

• excess 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 Physiological Serum Braun.

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

Electrolyte levels, water balance, and acid-base balance should be regularly monitored.

In the case of subcutaneous administration, no supplements should be added, as this would alter the isotonicity.

Children

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

The contraindications related to the added medicines should be taken into account.

Using Physiological Serum Braun with other medicines

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

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

It should be administered with caution in patients treated with corticosteroids or adrenocorticotropic hormone, as they may retain water and sodium.

The interactions that may appear are those corresponding to the medicines that are dissolved.

Before mixing with other medicines, compatibility tables should be checked, taking into account the pH and controlling ions.

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.

Physiological Serum Braun can be used when indicated during pregnancy and breastfeeding. The possible interactions are those corresponding to the medicines that are dissolved.

Driving and using machines

Medicines dissolved in physiological serum (sodium chloride 0.9%) may cause adverse effects on the ability to drive and use machines.

3. How to use Physiological Serum Braun

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

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

If you use more Physiological Serum Braun than you should

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

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

If you are not hospitalized, go to the nearest hospital or consult the Toxicology Information Service. Phone: 91 562 04 20, 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 side effects

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

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Physiological Serum Braun

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 which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

Do not use this medicine if the solution is cloudy or sedimentary (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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Physiological Serum Braun

The active substance is:

The other ingredients are: water for injections.

Appearance and pack contents

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

• Braun Melsungen, AG

Mistelweg 2,

12357 Berlin

Germany

Date of last revision of this leaflet: November 2019.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

Single-dose containers.

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

Discard any unused contents after administration is complete.

The solution should only be used if the container closure is not damaged and the solution is clear.

Before mixing the solution with other medicines, possible incompatibilities should be considered.

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