Label Information:Information for theUser

GLUCOSALINO HIPOSÓDICO BRAUN

Glucose 5% and Sodium Chloride 0.3%. Solution for Infusion

Read the entire label carefully before starting to use the medication

• Keep this label as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

Braun Hypertonic Glucose Solution is a perfusion solution (administered intravenously through a drip) that contains 5% glucose and 0.3% sodium chloride.

Braun Hypertonic Glucose Solution is mainly used for:

• replacing water losses in the body (dehydration) resulting from various alterations or disorders, and when the body's sodium level is also elevated (hypernatremia),
• regulating mild increases in basic substances in tissues or blood (mild alkalosis) due to a higher concentration of chlorides,
• to meet energy needs, as glucose is the primary source of energy for the body,
• as a solution to dissolve and transport other compatible medications.

Do not use GlucosalinoHypertonicBraun:

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

• In states of fluid overload (hyperhydration).
• In situations of fluid accumulation in body tissues (generalized edema) or chronic progressive liver disease with fluid accumulation (ascitic cirrhosis).
• In states of increased blood glucose levels (hyperglycemia).
• In states of decreased potassium in the blood (hypokalemia).
• In states of decreased sodium in the blood (hyponatremia).
• In states of decreased chloride in the blood (hypochloremia).
• In states of loss of consciousness due to an increase in blood osmolality (hypersomalor coma).
• In states of presence of lactic acid in the blood (hyperlactacidemia).
• In severe cases of heart, liver, or kidney failure.
• During the first 24 hours after a head trauma.

Be especially careful with GlucosalinoHypertonicBraun:

You will be given this medication with caution if you have the following diseases: hypertension, heart failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms that precede seizures and blood pressure drop in pregnant women), heart, liver, or kidney alterations, or if you are an elderly patient.

Your blood glucose levels will be carefully monitored in case of intracranial hypertension.

If you have had an acute ischemic stroke, this medication should not be administered to you.

If you are given 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. Ensure adequate vitamin intake (particularly vitamin B1).

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

Do not administer Glucosalino Hypertonic Braun with the same infusion equipment, at the same time, or before or after a blood transfusion, as incompatibilities may occur.

Regularly monitor your blood sugar, electrolytes (especially potassium), and fluid balance.

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

Avoid continuous administration 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 any other medication, including those purchased without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Certain medications may interact with Glucosalino Hypertonic Braun. In this case, it may be necessary to change the dose or interrupt treatment of one of the medications.

It is essential to inform your doctor if you are using any of the following medications:

-Insulin or oral antidiabetic medications (biguanides, sulfonylureas), which decrease the effect of glucose.

-Corticosteroids due to the risk of increased blood glucose or the ability of these medications to retain sodium and water.

-Digitoxin, which may cause an increase in digitalis activity, with a risk of developing intoxication.

-Lithium carbonate, as the administration of sodium chloride accelerates renal excretion of lithium, leading to a decrease in its therapeutic effect.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

The administration of Glucosalino Hypertonic Braun during pregnancy or lactation should be carried out following the instructions detailed in this prospectus.

This medication will always be administered by healthcare personnel.

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

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.

Follow exactly the administration instructions for Braun Hypo-Saline Glucose Solution indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

If you use more Braun Hypo-Saline Glucose Solution than you should

This is unlikely to happen since your doctor will determine your daily doses. However, if you receive more Braun Hypo-Saline Glucose Solution than you should, this could cause:

• excessive hydration
• a disturbance of the levels of electrolytes (substances with electric charge in the blood and other bodily fluids such as: sodium, calcium, chlorides) and acid-base balance (loss of equilibrium in the levels of acidic and basic substances in the body, which must always be kept constant)
• an increase in blood sugar concentration.

If this happens, treatment should be stopped immediately and, depending on the severity, administer:

• medicines that increase the elimination of water and salts (diuretics),
• electrolytes (such as sodium, calcium, chlorides…), or
• insulin.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call 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, Braun Hypo Glucosaline may produce adverse effects, although not everyone will experience them.

Adverse reactions associated with the administration technique may occur, including fever, infection at the injection site, local reaction or pain, venous irritation, venous thrombosis, or phlebitis extending from the injection site, extravasation, and hypervolemia.

Adverse reactions may be associated with the added medications in the solution; the nature of the added medications will determine the possibility of any other undesirable effect.

In the event of adverse reactions, administration should be interrupted.

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

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use Hypo-Glucose Braun after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use Hypo-Glucose Braun if the solution is not transparent, if you observe particles at the bottom, or if the packaging shows visible signs of deterioration.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. In this way, you will help protect the environment.

Composition of Glucosalino Hiposódico Braun:

The other components are: water for injection preparations.

Appearance of the product and contents of the package

Glucosalino Hiposódico Braun is a clear and colorless perfusion solution that is presented in Ecoflac Plus plastic bottles of 100 and 500 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 December 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices.

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This information is intended only for doctors or healthcare professionals:

The recommended perfusion rate is approximately 5 ml per kg of body weight per hour, which corresponds to 1.7 drops per kg of body weight per minute.

Single-use containers. Dispose of any unused content after completing the perfusion.

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

Use the sterile administration set for administration.

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

Do not administer Glucosalino Hiposódico Braun with the same perfusion equipment, simultaneously, or before or after a blood transfusion, as incompatibilities may occur.

On the other hand, incompatibility samples have been described when some medications are diluted in solutions containing glucose, including: sodium ampicillin, amrinone lactate, sodium amoxicillin/clavulanic acid, interferon alfa-2b, procainamide hydrochloride. However, amrinone lactate or sodium amoxicillin/clavulanic acid may be injected directly into the injection site while these perfusion solutions are being administered.

Incompatibility samples have also been described when some medications are diluted in solutions containing chloride. Among them, amsacrine and trimetrexate glucuronate.

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