GLUCOSALINO BRAUN 5% SOLUTION FOR INFUSION

Introduction

Leaflet: Information for the user

GLUCOSALINO BRAUN 5% solution for infusion

Glucose and Sodium Chloride

Read the entire leaflet carefully before starting to use 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 to you, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What is Glucosalino Braun 5% solution for infusion and what is it used for
2. Before using Glucosalino Braun 5% solution for infusion
3. How to use Glucosalino Braun 5% solution for infusion
4. Possible adverse effects
5. Storage of Glucosalino Braun 5% solution for infusion
6. Additional information

1. What is Glucosalino Braun 5% solution for infusion and what is it used for

Glucosalino Braun 5% is a solution for infusion that contains the same amount of sodium and chloride as plasma and also contains 5% glucose.

Glucosalino Braun 5% is used primarily to replace water and electrolytes (electrically charged substances found in the blood and other bodily fluids, such as sodium, potassium, and chlorides) when they are decreased due to various alterations or disorders, such as excessive water loss (dehydration) and chloride loss. It is also used to cover energy needs, as glucose is the primary source of energy for the body.

In addition, Glucosalino Braun 5% is used as a transport solution for other compatible medicines.

2. Before using Glucosalino Braun 5% solution for infusion

Do not use Glucosalino Braun 5% solution for infusion:

- If you are allergic to the active ingredients or to any of the other components of Glucosalino Braun 5%.

- In cases of hyperhydration (fluid overload).

- In situations of generalized edema (fluid accumulation in body tissues) or ascitic cirrhosis (a chronic progressive liver disease with fluid accumulation).

- In cases of hyperglycemia (elevated blood glucose levels).

- In cases of hypokalemia (decreased potassium levels in the blood).

- In cases of hyponatremia (decreased sodium levels in the blood).

- In cases of hypochloremia (decreased chloride levels in the blood).

- In cases of hyperosmolar coma (loss of consciousness due to increased salt concentration in the blood).

- In cases of hyperlactatemia (presence of lactic acid in the blood).

- In severe cases of cardiac, hepatic, or renal failure.

- During the first 24 hours after a head injury.

Be cautious when using Glucosalino Braun 5% solution for infusion:

- You will be administered this medicine with caution if you have the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, pre-eclampsia (symptoms preceding convulsions and decreased blood pressure in pregnant women), cardiac, hepatic, and/or renal disorders, or if you are an elderly patient.

- Your blood glucose levels will be carefully monitored if you have intracranial hypertension.

- If you have had an acute ischemic attack (sudden lack of blood flow), this medicine should not be administered to you.

- If you are administered this medicine for a prolonged period, it is recommended to add potassium to the solution as a safety measure.

- The administration of glucose-containing solutions may cause a deficiency of vitamin B1, especially in cases of malnutrition.

- If you have diabetes mellitus, glucose-containing solutions can be used as long as you have been initially treated with insulin. Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

- Glucosalino Braun 5% solution for infusion should not be administered with the same infusion equipment, either simultaneously or before or after a blood transfusion, as incompatibilities may occur.

- Blood sugar, electrolyte (especially potassium), and water balance levels should be regularly monitored.

- This type of solution should be administered with caution in children.

-Continuous administration at the same injection site should be avoided due to the risk of thrombophlebitis.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

The administration of Glucosalino Braun 5% as a medicine does not require any special precautions for pregnant or breastfeeding women.

Glucosalino Braun 5% can be used for the administration of other medicines if your doctor considers it necessary.

3. How to use Glucosalino Braun 5% solution for infusion

Follow your doctor's instructions for administering Glucosalino Braun 5% solution for infusion exactly. Consult your doctor or pharmacist if you have any questions.

The normal daily dose is up to 40 ml per kg of body weight.

The recommended infusion rate (slow intravenous administration) is approximately 5 ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute.

In postoperative patients or those in intensive care, the carbohydrate intake should be reduced, but the daily fluid intake should be increased to the maximum dose.

Your doctor will decide the dose and frequency at which the solution will be administered to you, depending on your age, weight, and clinical situation.

If you use more Glucosalino Braun 5% solution for infusion than you should

This is unlikely to happen, as your doctor will determine your daily doses. However, if you receive an overdose, it may cause:

• excess fluid in the body, imbalance of electrolyte levels, imbalance of the body's acid-base balance, and an increase in blood sugar concentration.

If this happens, the infusion should be stopped immediately, and depending on the severity of the situation, electrolytes, diuretic medicines, or insulin should be administered.

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

4. Possible adverse effects

Like all medicines, Glucosalino Braun 5% solution for infusion can cause adverse effects, although not everyone will experience them.

Administration of the solution may lead to:

- Changes in blood concentrations of chemical substances (electrolyte disorders).

If you have heart disease or fluid in the lungs (pulmonary edema):

- Excess fluid in the body (hyperhydration), which may cause you to urinate more frequently (polyuria).

- Heart failure.

- Low sodium levels in the blood (hyponatremia).

Adverse effects may be due to the administration technique. These include:

- Fever (febrile response).

- Infection at the injection site.

- Local pain or reaction (redness or swelling at the administration site).

- Irritation and inflammation of the vein in which the solution is infused (phlebitis). This may cause redness, pain, or burning and swelling along the vein in which the solution is infused.

- Formation of a blood clot (venous thrombosis) at the infusion site, which can cause pain, swelling, or redness in the area of the clot.

- Leakage of the infusion solution into the surrounding tissues (extravasation), which can damage tissues and cause scarring.

- Excess fluid in the blood vessels (hypervolemia).

If a medicine has been added to the infusion solution, it may also cause adverse effects. These adverse effects will depend on the added medicine. You should read the list of possible symptoms in the leaflet of the added medicine.

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 mentioned in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Glucosalino Braun 5% solution for infusion

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Glucosalino Braun 5% solution for infusion after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Glucosalino Braun 5% solution for infusion if you notice that the solution is not clear, there are particles at the bottom, or the packaging shows visible signs of deterioration.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of Glucosalino Braun 5% solution for infusion:

The other components are: water for injectable preparations.

Appearance of the product and packaging content:

Glucosalino Braun 5% is a clear and colorless solution for infusion, which is packaged in Ecoflac Plus plastic bottles of 250, 500, 1000 ml (not all sizes may be marketed).

Marketing authorization holder and manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in March 2015

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products.

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This information is intended only for healthcare professionals:

Single-use packaging. Discard any unused contents after completing the infusion.

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

Use the sterile administration set for administration.

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

Disposal of unused medicines and all materials that have come into contact with them will be carried out in accordance with local regulations.