Glucose B. Braun 30% solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Glucose B. Braun 30% solution for infusion

Read this entire leaflet carefully before you start using this 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 you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, especially if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Glucose B. Braun 30% is and what it is used for
2. What you need to know before using Glucose B. Braun 30%
3. How to use Glucose B. Braun 30%
4. Possible side effects
5. Storage of Glucose B. Braun 30%
6. Package contents and additional information

1. What Glucosa B. Braun 30% is and what it is used for

Glucosa B. Braun 30% is an infusion solution used for:

• providing a source of carbohydrates (sugar) for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is administered by infusion (slow injection) through a vein.

• preventing or treating low blood sugar levels (hypoglycemia).

• providing additional fluid to the patient when the body does not have enough water (dehydration).

2. What you need to know before using Glucosa B. Braun 30%

Do not use Glucosa B. Braun 30%:

If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

If you have:

• High blood glucose levels (hyperglycemia) or elevated blood lactate concentration (hyperlactatemia), diabetes mellitus, glucose intolerance, or diabetic coma.
• Low blood sodium or potassium levels (hyponatremia or hypokalemia).
• Blood dilution due to excessive fluid administration (hemodilution), or excess fluid in the body's extracellular spaces (extracellular hyperhydration).
• Severe renal failure (when kidneys do not function properly and dialysis is required) with anuria (suppressed urine production).
• After a cerebrovascular accident (hemorrhage).
• Low blood volume with hypoxia (oxygen deficiency in the body).
• During the first 24 hours after head trauma.

If large amounts of the solution need to be administered, additional contraindications may arise due to the infusion of high amounts of glucose and fluids.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glucosa B. Braun 30%.

Patients must be assessed considering water, ion, and blood glucose balance. Changes in these parameters may require appropriate treatment.

Prolonged administration of glucose may cause potassium, phosphate, or magnesium deficiency and may increase extracellular fluid volume, leading to water intoxication.

Rapid administration of concentrated glucose solutions may cause elevated glucose levels and hyperosmolar syndrome. The risk of cardiovascular system overload (heart and blood circulation) with fluid accumulation in the lungs (edema) should be considered, especially in sensitive patients or when high volumes of fluid are administered.

Frequent monitoring of blood glucose levels is required, and insulin should be administered if necessary: one unit per every 10 g of glucose.

For the treatment of hypoglycemia in neonates or young children, less concentrated glucose solutions (10–25%) are recommended.

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 cerebral edema (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 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 a certain risk of severe and potentially fatal cerebral edema caused by acute reduction in blood sodium levels.

Use with caution in elderly patients or those with liver problems.

Precautions and warnings related to any medication added to the glucose solution must be taken into account.

Use of Glucosa B. Braun 30% with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, especially the following medications 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 (medications that increase urine excretion).

The use of Glucosa B. Braun 30% with other medicines may alter the effectiveness of both treatments:

• Administration of glucocorticoids, diuretics, phenytoin, and chlorpropamide increases blood glucose levels.
• Intravenous glucose administration in patients treated with insulin or oral antidiabetics (biguanides, sulfonylureas) may reduce the therapeutic effectiveness of these agents.
• If glucose is administered together with digitalis glycosides (digoxin), increased digitalis activity may occur, increasing the risk of toxicity from these medications.

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 transfusion, due to the risk of agglutination.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Glucose crosses the placenta, whereas insulin does not; therefore, the fetus itself is responsible for insulin synthesis in response to glucose administration. Infusions exceeding 10 g/hour cause increased fetal insulin levels. Therefore, use with caution during pregnancy.

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

On the other hand, there is no evidence suggesting adverse effects on the neonate during breastfeeding. Nevertheless, caution is also recommended during this period.

3. How to use Glucosa B. Braun 30%

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine will be administered only by healthcare professionals, and the dosage depends on the patient's requirements, body weight, clinical condition, and metabolic status. According to individual needs, administer between 0.7 and 4 g of glucose per kg of body weight per day; or up to 0.5 g of glucose per kg of body weight per hour.

Your doctor will monitor 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 medicines that enhance the action of vasopressin, due to the risk of abnormally low blood sodium levels (hyponatremia).

Glucose 30% may become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you are given more Glucosa B. Braun 30% than you should

It is unlikely that this will occur, as your doctor will determine your daily doses. However, if you were to receive an overdose of the medicine, it could lead to excess body water (hyperhydration), high blood glucose levels (hyperglycemia), and disturbances in the salt balance in the blood (hyperosmolarity), which may result in altered consciousness, seizures, and coma.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Take this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

They may be signs of a very severe, even life-threatening, allergic reaction (hypersensitivity):

• skin swelling 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.

Other adverse effects include:

• changes in blood chemical levels (electrolyte imbalances affecting potassium, magnesium, or phosphate) and high blood sugar (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.
  • hospital-acquired hyponatremia.
  • Hyponatremic encephalopathy.

Reactions related to the route of administration:

• 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, stinging, or swelling at 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.

If any adverse effect occurs, the infusion must be stopped.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, 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 Glucose B. Braun 30%

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container (after EXP). The expiry date refers to the last day of the month indicated.

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 container and additional information

Composition of Glucose B. Braun 30%:

The active substance is Glucose. Each 500 ml container contains 150 g of Glucose (as monohydrate glucose, 330 mg/ml).

The other components (excipients) are hydrochloric acid (for pH adjustment) and water for injections.

Appearance of the product and contents of the container

Glucosa B. Braun 30% is an infusion solution presented in plastic bottles (Ecoflac Plus) (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

Date of the most recent review of this leaflet: October 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es.

This information is intended for healthcare professionals only:

The contents of each container are intended for single use only. Any unused portion must be discarded.

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

An aseptic procedure 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 currently in use, previously used, or intended to be used for blood administration, due to the risk of pseudoagglutination.

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