GLUCOSE BRAUN 10% SOLUTION FOR INFUSION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Glucosado Braun 10% solution for infusion

Glucose

Read the entire leaflet carefully before starting to use the medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse effects, consult your doctor, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Glucosado Braun 10% is and what it is used for
2. What you need to know before using Glucosado Braun 10%
3. How to use Glucosado Braun 10%
4. Possible adverse effects
5. Storage of Glucosado Braun 10%
6. Contents of the pack and other information

1. What Glucosado Braun 10% is and what it is used for

Glucosado Braun 10% is an infusion solution (administered intravenously via an infusion set) with a low concentration of glucose, used for:

• providing a source of carbohydrates (sugar), alone or, if required, for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is carried out by infusion (slow injection) through a vein.
• preventing or treating low blood sugar levels (moderate hypoglycemia, which causes symptoms but is not life-threatening).
• providing additional fluid to the patient when the body lacks sufficient water (dehydration) and extra carbohydrates (sugar) are needed.
• diluting with water other medications intended for intravenous administration.

2. What you need to know before using Glucosado Braun 10%

Do not use Glucosado Braun 10% if you have any of the following conditions:

• Allergy (hypersensitivity) to the active substance or to any of the other components of Glucosado Braun 10%.
• Untreated diabetes, resulting in blood glucose levels higher than normal (decompensated diabetes).
• Hyperosmolar coma. This is a type of coma that may occur if you have diabetes and are not receiving adequate medication.
• Blood dilution due to excessive fluid administration (hemodilution), when there is excess fluid in the body's extracellular spaces (extracellular hyperhydration), or increased blood volume in blood vessels beyond normal (hypervolemia).
• High blood glucose levels (hyperglycemia) or abnormally high blood lactate concentration (hyperlactatemia).
  • Severe renal failure (when kidneys do not function properly and dialysis is required) with anuria (suppressed urine production).
  • Inadequately treated heart failure.
  • Low blood potassium or sodium levels (hypokalemia or hyponatremia).
  • Fluid accumulation under the skin affecting the entire body, including the brain and lungs (generalized edema).
  • Liver disease causing fluid accumulation in the abdomen (ascitic cirrhosis).
  • After a cerebrovascular accident (hemorrhage).
  • During the first 24 hours following head trauma.
  • Any other condition affecting how your body regulates blood sugar levels.

If another medicine is added to your infusion solution, read its package leaflet to ensure that it is safe to use in combination.

Take special care with Glucosado Braun 10%:

Inform your doctor if you have:

• Diabetes mellitus. It may be used if appropriate insulin treatment is initiated beforehand.
• Kidney insufficiency.
• Increased pressure inside the skull (intracranial hypertension).
• Acute ischemic attacks (reduced or absent blood flow in arteries).
• Acid-base balance disturbances.
• Malnutrition with vitamin B1 deficiency (essential for glucose metabolism).

Glucosado Braun 10% must not be administered using the same infusion equipment, nor simultaneously, before, or after a blood transfusion, due to possible incompatibilities.

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

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

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

Critically ill patients, those experiencing pain, postoperative stress, infections, burns, nervous system, cardiac, hepatic, or renal diseases, and patients taking medications that enhance vasopressin effects (a hormone regulating body fluid levels), are at a certain risk of developing abnormally low blood sodium levels (acute hyponatremia) when receiving this solution, which may lead to brain swelling (encephalopathy).

Acute hyponatremia may cause acute hyponatremic 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 severe brain disorders such as meningitis (infection of the membranes surrounding the brain) or brain injury are at increased risk of severe and potentially fatal brain swelling caused by acute reduction in blood sodium levels.

Elderly patients require special attention due to possible impaired liver and/or kidney function.

Do not administer by intramuscular route.

Use of other medicines

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

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

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

• Certain hormones (catecholamines), including adrenaline or corticosteroids: due to the risk of increased blood glucose.

• Digitalis glycosides (digoxin): if intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), there is a risk of developing toxicity from these medicines.

• Medicines that increase vasopressin effects and the risk of low sodium levels (hyponatremia):

  • Carbamazepine and oxcarbazepine used for epilepsy treatment.
  • Vincristine and ifosfamide used for cancer treatment.
  • Cyclophosphamide used for cancer and autoimmune diseases.
  • Selective serotonin reuptake 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 treatment of body inflammation.
  • Desmopressin for treating 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 (medicines that increase urine excretion).

Your doctor will check the compatibility of this solution with any additive before use. These solutions must not be administered using the same infusion sets used or intended for blood administration, due to the risk of agglutination.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Glucosado Braun 10% can be safely used during pregnancy and breastfeeding. However, your doctor will monitor your body's chemical levels and fluid balance, which must remain within normal ranges.

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

However, if another medicine is added to the infusion solution during pregnancy or breastfeeding, you must consult your doctor and read the package leaflet of the added medicine.

3. How to use Glucosado Braun 10%

Follow exactly the administration instructions for Glucosado Braun 10% as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

It will be administered only by healthcare personnel, and the dose will depend on the requirements imposed by the patient's condition, age, weight, physical status, and the reason for treatment. The amount you receive may also be influenced by other treatments you are undergoing.

Your doctor will monitor your fluid balance, blood glucose levels, and electrolyte levels (primarily 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 Braun 10% may become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you receive more Glucosado Braun 10% than you should

It is unlikely that this will occur, as your doctor will determine your daily doses. However, if you receive an excessive amount of Glucosado Braun 10% (overdose), or if it is administered too rapidly or too frequently, the following symptoms may occur:

• dilution of the blood (hemodilution) and excess fluid in the blood vessels (hypervolemia).
• an increase in blood sugar concentration and glucosuria (glucose in urine).
• excessive concentration of certain chemicals in the blood (hyperosmolarity).
• increased urine production (osmotic diuresis).
• loss of water from the body (dehydration).
• an imbalance in the levels of salts and acidic and basic substances in the body.

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 any medication has been added before administration, that medication may also cause symptoms in case of overdose. You should read the list of possible symptoms in the package leaflet of the

added medication.

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 10% can cause adverse effects, although not everyone will experience them.

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. They may be signs of a very serious or even life-threatening allergic reaction (hypersensitivity):

• swelling of the skin of the face and lips or swelling of the throat.
• difficulty breathing.
• skin rash.
• redness of the skin (cutaneous erythema).
• hives (urticaria).

You will be prescribed treatment according to the symptoms.

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

Other adverse effects include:

• high blood sugar level (hyperglycemia).

• excess fluid in the blood vessels (hemodilution and hypervolemia).

• sugar in the urine (glucosuria).

• chills.

• sweating.

• fever (febrile reaction).

• infection at the injection site.

• administration route-related reactions:

  • local reaction or pain (redness or swelling at the infusion site).
  • irritation and inflammation of the vein used for infusion (phlebitis). This may cause redness, pain, burning, or swelling in the infusion vein.
  • formation of a blood clot (venous thrombosis) at the infusion site, causing pain, swelling, or redness in the area of the clot.
  • leakage of the infusion solution into the surrounding tissues (extravasation). This may damage tissues and lead to scarring.

• Hospital-acquired hyponatremia.

• Hyponatremic encephalopathy.

Inform your doctor or nurse if you notice any adverse effect listed in this leaflet or not. If any adverse effect occurs, the infusion should be stopped.

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 via 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 10%

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Glucosado Braun 10% after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Do not use Glucosado Braun 10% if the solution is cloudy or shows sedimentation, or if the container shows visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Glucosado Braun 10%:

The other components are: water for injections.

Appearance of the medicinal product and contents of the container:

Glucosado Braun 10% is an infusion solution presented in low-density polyethylene bottles (Ecoflac Plus®) of 100, 250 and 500 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 leaflet was approved in October 2019.

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

This information is intended for healthcare professionals only:

Each container is intended for single use only. Any unused portion must be discarded.

The infusion solution should be visually inspected prior to use. The solution must be clear and free from precipitates, and the container must be intact. Do not administer if these conditions are not met.

An aseptic technique must be used when administering the solution and when adding medications, if necessary.

Before adding medications to the solution or administering concomitantly with other drugs, compatibility must be verified.

These solutions must not be administered using the same infusion sets that are being used, have been used, or will be used for blood transfusion, due to the risk of pseudoagglutination.

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