GLUCOSADO 5% BRAUN SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Braun Glucosado 5% Solution for Infusion

glucose

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Braun Glucosado 5% and what is it used for
2. What you need to know before you use Braun Glucosado 5%
3. How to use Braun Glucosado 5%
4. Possible side effects
5. Storage of Braun Glucosado 5%
6. Contents of the pack and further information

1. What is Braun Glucosado 5% and what is it used for

Braun Glucosado 5% is a solution for infusion (administered intravenously via a drip) with a low concentration of glucose, used:

• for the treatment of water loss (hypertonic dehydration) due to vomiting, diarrhea,
• as an energy source in parenteral nutrition when oral food intake is limited,
• for disturbances in carbohydrate metabolism (glucose deficiency or hypoglycemia, insulin coma, hepatic coma, vomiting),
• as a vehicle and diluent for other medicines or solutions with electrolytes (electrically charged substances such as sodium, potassium, and chlorides).

2. What you need to know before you start using Braun Glucosado 5%

Do not use Braun Glucosado 5%:

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

If you have:

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

Patient with critical conditions, pain, postoperative stress, infections, burns, nervous system diseases, cardiac, hepatic, and renal diseases, and patients taking medications that increase the effect of vasopressin (hormone regulating body fluids), when administered this solution has a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to brain inflammation (encephalopathy).

Acute hyponatremia can cause acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at special risk of suffering severe, irreversible, and potentially fatal brain damage.

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

Be careful with Braun Glucosado 5%:

Tell your doctor if you have:

• diabetes mellitus. It can be used if adequate insulin treatment is initiated beforehand
• kidney failure.

• intracranial hypertension.
• acute ischemic attacks (decreased or absent circulation in arteries).
• acid-base balance disorders.
• malnutrition with vitamin B1 deficiency (essential for glucose metabolism).

Braun Glucosado 5% should not be administered with the same infusion equipment (equipment used to administer medications directly into the blood), either at the same time, before, or after a blood transfusion, as incompatibilities may occur.

Regular monitoring of blood sugar levels, electrolyte levels, and water balance should be performed.

Adequate vitamin intake (particularly vitamin B1) should be ensured.

Potassium may be administered along with glucose solution to prevent hypokalemia (low potassium levels in the blood) that may occur during parenteral nutrition.

Continuous administration and infusion at the same site may cause thrombophlebitis (inflammation of the veins).

Particular attention will be paid to elderly patients, as they may have impaired hepatic and/or renal function.

Do not administer intramuscularly.

Using Braun Glucosado 5% Solution for Infusion with other medicines

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

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

• Insulin or oral antidiabetics (biguanides, sulfonylureas): these medications decrease the effect of glucose.
• Corticosteroids: due to the risk of increased blood glucose levels or the ability of these medications to retain sodium and water.
• Digitalis glycosides (digoxin): If intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), there is a risk of developing toxicity from these medications.
• Medications that increase the effect of vasopressin and the risk of low sodium levels (hyponatremia):

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

In case of pregnancy, your doctor will decide whether to use the 5% glucose solution, as it should be used with caution in this case. The administration of glucose intravenously during pregnancy may increase glucose and insulin levels as well as acidic components in the fetal blood.

Glucose solutions should be administered with special caution in pregnant women during childbirth, especially if administered in combination with oxytocin, due to the risk of hyponatremia.

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

3. How to use Braun Glucosado 5%

Follow the administration instructions of Braun Glucosado 5% exactly 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, depending on your age, weight, and clinical situation.

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

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

If you use more Braun Glucosado 5% than you should

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

• excess hydration,
• an imbalance in salt and acid-base levels in the body, and
• an increase in blood sugar levels and glucosuria (glucose in urine).

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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Braun Glucosado 5% can cause side effects, although not everyone gets them.

Hyperglycemia, glucosuria, or disturbances in fluid or electrolyte balance may occur if administered too quickly or if the fluid volume is excessive, or in cases of metabolic failure, hospital hyponatremia, or hyponatremic encephalopathy.

You may develop an imbalance in fluid and mineral levels in your body. You may develop low sodium (hyponatremia), potassium, phosphate, and magnesium levels in the blood.

A local reaction may occur at the injection site.

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

Your doctor will assess whether it is necessary to discontinue the medication.

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Braun Glucosado 5%

Keep out of the sight and reach of children.

No special storage conditions are required.

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

Do not use Braun Glucosado 5% if the solution is cloudy or precipitated or if the packaging shows visible signs of deterioration.

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

6. Contents of the pack and further information

Composition

The active substance of Braun Glucosado 5%:

The other ingredients are: water for injectable preparations.

Appearance of the product and packaging:

Braun Glucosado 5% is a solution for infusion that comes in plastic bottles (Ecoflac Plus) of 50, 100, 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 December 2024.

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

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