Prospect: information for the user

Glucosado Braun 5% solution for perfusion

glucose

Read the entire prospect carefully before starting to use the medication,because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

Glucosado Braun 5% is a perfusion solution (administered intravenously through an infusion set) with a low concentration of glucose that is used:

• for the treatment of excessive water loss (hypertonic dehydration) due to vomiting, diarrhea,
• as an energy supplement in parenteral nutrition when oral food intake is limited,
• carbohydrate metabolism disorders (glucose deficiency or hypoglycemia, insulin excess coma, hepatic coma, vomiting),
• as a vehicle and diluent for other medications or electrolyte solutions (substances with electric charge such as sodium, potassium, and chlorides).

Do not use Glucosado Braun 5%:

• if you are allergic (hypersensitive) to the active ingredients or any of the other components of Glucosado Braun 5%.

If you have:

• edema due to accumulation of fluid in tissues,
• high blood glucose levels (hyperglycemia),
• low potassium levels (hypokalemia),
• acidosis (excess of acidity in the blood),
• significant alteration of glucose tolerance,
• excessive water (hyperhydration),
• hypotonic dehydration (greater loss of salts than water),
• within the first 24 hours after a head trauma.

Patients with critical states, pain, postoperative stress, infections, burns, neurological, cardiac, hepatic, and renal diseases, and patients taking medications that increase the effect of vasopressin (hormone that regulates the amount of body fluids), when this solution is administered, have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to cerebral inflammation (encephalopathy).

Acutely low sodium levels in the blood can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, convulsions, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, fertile women, and patients with severe brain diseases such as meningitis (infection in the membranes surrounding the brain) or brain damage run a certain risk of severe and potentially fatal cerebral inflammation caused by a sudden decrease in blood sodium levels.

Be especially careful with Glucosado Braun 5%:

Inform your doctor if you have:

• diabetes mellitus. It can be used if proper treatment with insulin is initiated first.
• renal insufficiency.

-intracranial hypertension.

-acute ischemic attacks (decrease or absence of circulation in arteries).

-acid-base balance alterations.

-malnutrition with vitamin B1 deficiency (essential for glucose metabolism).

Do not administer Glucosado Braun 5% with the same infusion equipment(equipment used to administer medications directly into the blood), nor at the same time, nor before or after a blood transfusion, as incompatibilities may occur.

Regularly monitor your blood sugar levels, electrolyte levels, and fluid balance.

Ensure adequate vitamin intake (particularly vitamin B1).

In addition to glucose solution, potassium may be administered to prevent hypokalemia (low potassium levels in the blood) that may occur during parenteral nutrition.

Continued administration in the same infusion site may cause thrombophlebitis (inflammation of the veins).

Special attention will be given to elderly patients, as they may have impaired liver and/or kidney function.

Do not administer by intramuscular route.

Use of Glucosado 5% Braun solution for infusion with other medications

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

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

• Insulin or oral antidiabetic medications (biguanides, sulfonylureas): these medications 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 glucosides (digoxin): If intravenous glucose administration coincides with treatment with digitoxin glucosides (digoxin), there is a risk of developing toxicity from these medications.
• Medications that increase the effect of vasopressin and the risk of having low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used for epilepsy treatment.
• Vincristine and Ifosfamide used for cancer treatment.
• Cyclophosphamide for cancer and autoimmune disease treatment.
• Selective serotonin receptor inhibitors (SSRIs) for depression treatment.
• Antipsychotics for mental disorders.
• Opioid analgesics for severe pain relief.
• Non-steroidal anti-inflammatory drugs (NSAIDs) for mild to moderate pain relief and to treat bodily inflammation.
• Desmopressin for diabetes insipidus (extreme thirst and continuous production of large volumes of diluted urine).
• Oxytocin used during childbirth.
• Vasopressin and terlipressin used for treating esophageal varices (dilated veins in the esophagus caused by liver problems).
• Diuretics (medications that increase urine excretion).

In any case, the doctor should check the compatibility of the added medications.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

During pregnancy, your doctor will decide whether to use 5% glucose solution, as it should be used with caution in this case. Intravenous glucose administration during pregnancy can elevate glucose and insulin levels, as well as acidic components in the blood of the fetus.

Solutions of glucose should be administered with special caution in pregnant women during childbirth, especially if they are administered in combination with oxytocin, due to the risk of hyponatremia.

There is no evidence to suggest that 5% glucose may cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.

Follow exactly the administration instructions for Glucosado Braun 5% 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 administration 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.

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.

Your doctor will monitor your fluid balance, glucose levels, and electrolyte levels (mainly sodium) in the blood before and during treatment, especially in patients with alterations in vasopressin release (hormone that regulates body fluids) and in patients taking medications that increase the action of vasopressin due to a risk of abnormally low sodium levels in the blood (hyponatremia).

Glucosado 5% Braun can become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you use more Glucosado Braun 5% than you should

This is unlikely to happen since your doctor will determine your daily doses. However, if you receive an overdose, this could cause:

• excessive hydration,
• imbalance in the levels of salts and acidic and basic substances in the body, and
• an increase in blood glucose concentration and glucosuria (glucose in urine).

If this happens, the infusion should be stopped immediately and, depending on the severity of the situation, electrolytes, diuretics, 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, Glucosado Braun 5% may produce adverse effects, although not everyone will experience them.

Hyperglycemia, glycosuria, or alterations in fluid or electrolyte balance may occur if administered too quickly or with excessive fluid volume, or in cases of metabolic insufficiency, hospital-acquired hyponatremia, or hypnatremic encephalopathy.

You may develop a fluid and electrolyte imbalance in your body. You may develop low levels of sodium (hyponatremia), potassium, phosphate, and magnesium in your blood.

A local reaction may occur at the site of injection.

If used as a vehicle for administering other medications, the nature of the added medications will determine the likelihood of other adverse reactions.

Your doctor, who will evaluate the advisability of suspending the medication.

If you consider any of the adverse effects you are experiencing to be severe or appreciate any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 Medications 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 sight and reach of children.

No special storage conditions are required.

Do not use Glucosado Braun 5% after the expiration date shown on the container. The expiration date is the last day of the month indicated.

Do not use Glucosado Braun 5% if the solution appears cloudy or has sedimentation, or if the container shows visible signs of deterioration.

Medicines should not be disposed of through drains or in the trash. Dispose ofunused containers and medicines at the SIGRE collection pointofthe pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition

The active principle of Glucosado Braun 5%:

The other components are: water for injection preparations.

Appearance of the product and contents of the packaging:

Glucosado Braun 5% is a perfusion solution that is presented in plastic flasks (Ecoflac Plus) of 50, 100, 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 December 2024.

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 unused content after completing the perfusion.

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

Use the sterile administration set for administration.

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