Glucose B. Braun 20% solution for infusion

Patient Information Leaflet

Introduction

PATIENT INFORMATION LEAFLET

Glucose B. Braun 20% solution for infusion

Read the entire leaflet carefully before starting to use 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.

• If you experience adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Glucosa B.Braun 20% is and what it is used for
2. What you need to know before using Glucosa B.Braun 20%
3. How to use Glucosa B.Braun 20%
4. Possible adverse effects
5. Storage of Glucosa B.Braun 20%

Pack contents and additional information

1. What Glucosa B. Braun 20% is and what it is used for

Glucosa B. Braun 20% is an infusion solution (administered intravenously via an infusion set) used for:

• providing a source of carbohydrates (sugar) 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 (hypoglycaemia).
• providing additional fluid to the patient when the body does not have enough water (dehydration).
• as a supportive solution for administering other compatible medicines.

2. What you need to know before using Glucosa B. Braun 20%

Do not use Glucosa B. Braun 20%:

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

If you have:

• significant impairment of glucose tolerance.
• high blood glucose levels (hyperglycemia) or elevated blood lactate concentration (hyperlactatemia).
• low blood potassium or sodium levels (hypokalemia or hyponatremia).
• edema due to fluid accumulation in tissues.
• hypotonic dehydration (greater loss of salts than water).
• blood thinning due to excessive fluid administration (hemodilution) and excess fluid in the body's extracellular spaces (extracellular hyperhydration).
• severe renal insufficiency (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

Patients should be evaluated considering water, electrolyte, 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 large volumes of fluid are administered.

Blood glucose levels should be monitored frequently, and insulin should be administered if necessary: one unit for every 10 g of glucose.

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.

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 regulating body fluid levels), are at 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 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 cerebral edema caused by acute reduction in blood sodium levels.

Use of Glucosa B. Braun 20% 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.

The use of Glucosa B. Braun 20% with other medicines may alter the effectiveness of both treatments:

Administration of glucocorticoids, diuretics, phenytoin, and chlorpromazine increases blood glucose levels.

Intravenous glucose administration in patients treated with insulin or oral antidiabetics (biguanides, sulfonylureas) may reduce the therapeutic efficacy of these agents.

If glucose is administered together with digitalis glycosides (digoxin), increased digitalis activity may occur, increasing the risk of toxicity from these medicines.

Medicines that increase vasopressin effect and risk of low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used for epilepsy treatment.
• Vincristine and ifosfamide used for cancer treatment.
• Cyclophosphamide for treating cancer and autoimmune diseases.
• Selective serotonin reuptake inhibitors (SSRIs) for treating depression.
• 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 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 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 equipment used or intended for blood transfusion due to the risk of agglutination.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 increases in fetal insulin. Therefore, use with caution during pregnancy.

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

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 20%

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

This medicine will be administered only by healthcare personnel, and the dosage depends on the requirements imposed by the patient's condition, body weight, clinical status, and metabolic state. 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 (particularly sodium) in the blood before and during treatment, especially in patients with disturbances in vasopressin release (the hormone regulating body fluids) and in patients taking medications that enhance the action of vasopressin, due to the risk of abnormally low blood sodium levels (hyponatremia).

Glucosa B. Braun 20% may become extremely hypotonic after administration due to glucose metabolism in the body.

If you use more Glucosa B. Braun 20% 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 (hyperosmolality), 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. Bring this leaflet with you.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

They may be signs of a very severe, 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 through which the infusion is administered (phlebitis). This may cause redness, pain, stinging, 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.

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 Medicinal Products: 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 20%

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. 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 containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Glucose B.Braun 20%

The active substance is Glucose. Each 500 ml container contains 100 g of Glucose (as monohydrate glucose, 220 mg/ml).

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

Energy value: 800 kcal/l

Theoretical osmolarity: 1,110 mOsm/l

Acidity (up to pH 7.4): <1.0 mmol/l

pH: 3.5 – 5.5

Appearance of the product and contents of the container:

Glucose B.Braun 20% is an infusion solution presented in plastic bottles (Ecoflacplus) of 500 ml (not all sizes may be marketed).

Clinical pack: 10 bottles of 500 ml

Marketing Authorization Holder

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Or

• BRAUN MELSUNGEN AG

Carl-Braun Strasse, 1

D-34212 Melsungen, Germany

Date of the most recent revision of this leaflet: October 2019.

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

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This information is intended for healthcare professionals only:

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

The infusion solution should be visually inspected before use. The solution must be clear and free from particulate matter, 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, have been, or will be used for blood administration, due to the risk of pseudoagglutination.

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