Glucose 5% Braun solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucosado Braun 5% infusion solution

glucose

Read the entire package leaflet carefully before starting to use this medicine, because it contains important information for you.

• 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 for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Glucosado Braun 5% is an intravenous infusion solution (administered intravenously via an infusion set) with a low glucose concentration, used:

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

2. What you need to know before starting to use Glucosado Braun 5%

Do not use Glucosado Braun 5%:

• if you are allergic (hypersensitive) to the active substances or to any of the other components of Glucosado Braun 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),
• significantly impaired glucose tolerance,
• excess body water (hyperhydration),
• hypotonic dehydration (greater loss of salts than water),
• within the first 24 hours after a head injury.

Patients in critical conditions, experiencing pain, postoperative stress, infections, burns, nervous system, cardiac, hepatic or renal diseases, and patients taking medications that enhance the effect of vasopressin (a hormone that regulates body fluid levels), are at a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) when administered this solution, which may lead to brain swelling (encephalopathy).

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

Children, women of childbearing age, and patients with serious brain disorders such as meningitis (infection of the membranes surrounding the brain) or brain injury are at increased risk of severe and potentially fatal cerebral swelling caused by an acute decrease in blood sodium levels.

Take special care with Glucosado Braun 5%:

Inform your doctor if you have:

• diabetes mellitus. It may be used if appropriate insulin therapy is initiated beforehand.
• kidney insufficiency.
• increased intracranial pressure.
• acute ischemic episodes (reduced or absent blood flow in arteries).
• acid-base balance disorders.
• malnutrition with vitamin B1 deficiency (thiamine, essential for glucose metabolism).

Glucosado Braun 5% must not be administered through the same infusion set (equipment used to deliver medications directly into the bloodstream), either simultaneously or sequentially, before or after a blood transfusion, due to possible incompatibilities.

Your blood glucose levels, electrolyte levels, and fluid balance should be monitored regularly.

An adequate supply of vitamins (particularly vitamin B1) must be ensured.

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

Continuous administration at the same infusion site may lead to thrombophlebitis (vein inflammation).

Particular caution should be exercised in 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 medicines

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

It is important that you inform your doctor if you are taking any of the following medicines:

• Insulin or oral antidiabetics (biguanides, sulfonylureas): these medications reduce the effect of glucose.

• Corticosteroids: due to the risk of increased blood glucose levels or because these drugs may 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 drugs.

• Medications that increase the effect of vasopressin and the risk of low sodium levels (hyponatremia):

  • Carbamazepine and oxcarbazepine, used for the treatment of epilepsy.
  • Vincristine and ifosfamide, used for cancer treatment.
  • Cyclophosphamide, used for cancer and autoimmune diseases.
  • Selective serotonin reuptake inhibitors (SSRIs), used to treat depression.
  • Antipsychotics, for mental disorders.
  • Opioid analgesics, for relief of severe pain.
  • Non-steroidal anti-inflammatory drugs (NSAIDs), for relief of mild to moderate pain and treatment of body inflammation.
  • Desmopressin, used to treat diabetes insipidus (extreme thirst and continuous production of large volumes of dilute 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 physician must verify the compatibility of any added medications.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

During pregnancy, your doctor will decide whether the use of 5% glucose solution is appropriate, as it should be used with caution in this case. Intravenous glucose administration 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 labor, particularly if administered in combination with oxytocin, due to the risk of hyponatremia.

There is no evidence suggesting that 5% glucose may cause adverse effects in the neonate during breastfeeding. Nevertheless, caution is recommended during this period.

3. How to use Glucosado Braun 5%

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 infusion rate is approximately 5 ml per kg of body weight per hour, corresponding to 1.7 drops per kg of body weight per minute.

Your doctor will decide the dose and frequency with which the solution will be administered, depending on your age, weight, and clinical condition.

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

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

If you use more Glucosado Braun 5% than you should

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

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

If this occurs, the infusion must 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 adverse effects

Like all medicines, Glucosado Braun 5% can produce adverse effects, although not everyone will experience them.

Hyperglycemia, glycosuria, or disturbances in fluid or electrolyte balance may occur if the solution is administered too rapidly, if the fluid volume is excessive, or in cases of metabolic insufficiency, hospital-acquired hyponatremia, or hyponatremic encephalopathy.

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

A local reaction at the injection site may occur.

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

Your doctor will assess whether it is appropriate to discontinue treatment.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosado Braun 5%

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Glucosado Braun 5% after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition

The active substance in Glucosado Braun 5%:

The other components are: water for injections.

Appearance of the medicinal product and contents of the container:

Glucosado Braun 5% is an infusion solution supplied in plastic bottles (Ecoflac Plus) of 50, 100, 250, 500, and 1000 ml (not all sizes may be marketed).

Marketing Authorization Holder and Manufacturing Responsible Party

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This patient information leaflet was approved in December 2024.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS).

This information is intended for healthcare professionals only:

Single-use containers. Discard any unused residual contents after completion of infusion.

The solution should only be used if the container closure is intact and the solution is clear.

Use a sterile administration set for administration.

Disposal of unused medicine and of all materials which have been in contact with it must be carried out in accordance with local regulations.