Leaflet: information for the user

GLUCOSALINO BRAUN 5 % solution for infusion

Glucose and Sodium Chloride

Read this leaflet carefully before starting to use the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before using Glucosalino Braun 5% solution for infusion

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

4. Possible side effects

5. Storage of Glucosalino Braun 5% solution for infusion

6. Additional information

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

Glucosalino Braun 5% is mainly used to replace water and electrolytes (substances with electric charge found in blood and other bodily fluids, such as sodium, potassium, and chlorides), when these are decreased as a result of different alterations or disorders such as excessive water loss (dehydration) and chloride. It is also used to meet energy needs, since glucose is the main source of this for the body.

Glucosalino Braun 5% is also used as a transport solution for other compatible medications.

No use Glucosalino Braun 5% solution for perfusion:

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

-In states of hyperhydration (overload of fluid).

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

-In states of hyperglycemia (increase in blood glucose level).

-In states of hypokalemia (decrease in potassium in blood).

-In states of hyponatremia (decrease in sodium in blood).

-In states of hypochloremia (decrease in chloride in blood).

-In states of hyperosmolar coma (loss of consciousness due to an increase in blood salt concentration).

-In states of hyperlactacidemia (presence of lactic acid in blood).

-In severe cases of heart, liver, or renal insufficiency.

-During the first 24 hours after a head trauma.

Be especially careful with Glucosalino Braun 5% solution for perfusion:

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

-Your blood glucose level will be carefully determined if you have intracranial hypertension.

-If you have had an acute ischemic stroke (sudden appearance of blood flow deficiency), this medication should not be administered to you.

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

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

-If you have diabetes mellitus, solutions containing glucose may be used as long as you have been initially established with the appropriate treatment (insulin). Similarly, these solutions should be used with caution if you have Addison's disease or carbohydrate intolerance.

-Do not administer Glucosalino Braun 5% solution for perfusion with the same infusion equipment, nor at the same time, nor before or after a blood transfusion, as incompatibilities may occur.

-Your blood sugar, electrolytes (especially potassium), and fluid balance should be regularly monitored.

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

-Administration should be avoided in the same injection site due to the risk of thrombophlebitis.

Use of other medications

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

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

Follow exactly the administration instructions for Glucosalino Braun 5 % Solution for Infusion as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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 or intensive care patients, carbohydrate intake should be reduced, but fluid administration should be increased to the maximum daily dose.

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

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, electrolyte imbalance, acid-base balance imbalance in the body, 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 medications, or insulin should be administered.

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

Like all medications, Glucosalino Braun 5% Solution for Infusion may cause adverse effects, although not everyone may experience them.

The administration of the solution may lead to:

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

If you have any heart disease or have fluid in your 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 through which the solution is infused (phlebitis). This may cause redness, pain, or burning and swelling along the vein through which the solution has been infused.

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

-Leakage of the infusion solution into the tissues surrounding the vein (extravasation), which may damage the tissues and cause the formation of scars.

-Excess fluid in the blood vessels (hypervolemia).

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

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 the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use Glucosaline Braun 5 % solution for perfusion 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 Glucosaline Braun 5 % solution for perfusion if you observe that the solution is not clear, particles at the bottom, or if the packaging shows visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you do not need. In this way, you will help protect the environment.

Composition of Glucosalino Braun 5% solution for perfusion:

The other components are: water for injection preparations.

Appearance of the product and contents of the packaging:

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

Holder of the marketing authorization and responsible for manufacturing

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This prospectus was approved in March 2015

The detailed information of this medication 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:

Disposable containers. Dispose of any remaining unused content after completing the perfusion.

Only use the solution if the packaging seal is not damaged and the solution is clear.

Use the sterile administration set for administration.

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

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.