Sodium chloride 0.9% Braun solvent for parenteral use
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Suero Fisiológico Braun is and what it is used for
- 2. What you need to know before using Sodium Chloride Solution Braun
- 3. How to use Braun Physiological Saline
- 4. Possible adverse effects
- 5. Storage of Braun Physiological Saline
- 6. Package contents and additional information
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Chloride Solution 0.9% Braun
Solvent for parenteral use
Sodium chloride
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you
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Package leaflet:
- What Suero Fisiológico Braun is and what it is used for
- What you need to know before using Suero Fisiológico Braun
- How to use Suero Fisiológico Braun
- Possible side effects
- How to store Suero Fisiológico Braun
- Contents of the pack and other information
1. What Suero Fisiológico Braun is and what it is used for
Suero Fisiológico Braun belongs to the group of intravenous solution medicines.
Suero Fisiológico Braun is used as a carrier solution for other compatible medications and for the treatment of hyponatremia and hypochloremic metabolic alkalosis.
2. What you need to know before using Sodium Chloride Solution Braun
Do not use Sodium Chloride Solution Braun:
- If you are allergic to the active substance or to 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 using Sodium Chloride Solution Braun.
If you have disorders in which restriction of sodium intake is indicated, 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.
Serum electrolytes, water balance, and acid-base equilibrium should be monitored regularly.
When administered subcutaneously, no supplements should be added, as this would alter the isotonicity.
Children
In premature infants and infants, administration of sodium chloride should only be given after serum sodium levels have been determined.
Contraindications related to added medications must be taken into account.
Use of Sodium Chloride Solution Braun with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Administration of sodium chloride increases renal excretion of lithium, leading to a reduction in its therapeutic effect.
It should be administered with caution in patients treated with corticosteroids or adrenocorticotropic hormone, as these may cause water and sodium retention.
Potential interactions are those associated with the medicines dissolved in the solution.
Before mixing with other medicines, compatibility tables should be checked, the pH taken into account, and ions monitored.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Sodium Chloride Solution Braun may be used during pregnancy and breastfeeding when indicated. Possible interactions are those associated with the medicines dissolved in the solution.
Driving and using machines
Medicines dissolved in sodium chloride solution (0.9%) may cause adverse effects on the ability to drive and use machines.
3. How to use Braun Physiological Saline
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
The dose and method of administration depend on the medicine to be dissolved in the physiological saline, as well as on the patient's age, weight, and clinical condition.
Before dissolving a medicine, it is necessary to verify that it is soluble and compatible with physiological saline.
If you use more Braun Physiological Saline than you should
Signs and symptoms of overdose may also be related to the nature of the added medicine.
In case of overdose or accidental ingestion, administration must be stopped immediately and the patient should be treated according to the symptoms.
If you are not hospitalized, go to the nearest hospital or contact the Toxicology Information Service. Telephone: 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 adverse effects
Like all medicines, this medicine can produce adverse effects, although not everyone will experience 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 occurring.
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 Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Braun Physiological Saline
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 after EXP. 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 packaging shows visible signs of deterioration.
Medicines must not be disposed of via wastewater drains or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Suero Fisiológico Braun
The active substance is:
Active Ingredient | Per 5 ml | Per 10 ml | Per 20 ml |
Sodium chloride | 45 mg | 90 mg | 180 mg |
Electrolytes | mmol/l | mEq/l |
Sodium | 154 | 154 |
Chloride | 154 | 154 |
Theoretical Osmolarity | 308 mOsm/l | |
pH | 4.5 – 7.0 |
The other components are: water for injections.
Appearance of the product and content of the container
Sodium Chloride Solution Braun is a clear, colourless solution supplied 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. Mini-Plasco® Basic ampoules of 10 ml and 20 ml are also available in packs containing 50 ampoules.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 latest review of this package leaflet: November 2019.
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
This information is intended for healthcare professionals only:
Single-use containers.
After opening the container, the product must be used immediately.
Any unused residual contents should be discarded after administration.
The solution should only be used if the container closure is undamaged and the solution is clear.
Before mixing the solution with other medicinal products, possible incompatibilities must be considered.
When used as a solvent for medicinal products and/or as a diluent for solutions for parenteral administration, the osmolarity of the final solution should be checked and, whenever possible, its isotonicity with plasma should be adjusted prior to administration.