Glucose B. Braun 40% solution for infusion

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Glucose B. Braun 40% solution for infusion

Read the 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 must not be given 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Glucosa B. Braun 40% is and what it is used for

2. What you need to know before using Glucosa B. Braun 40%

3. How to use Glucosa B. Braun 40%

4. Possible adverse effects

5. Storage of Glucosa B. Braun 40%

6. Contents of the pack and other information

1. What Glucosa B. Braun 40% is and what it is used for

Glucosa B. Braun 40% is a solution for infusion 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 40%

Do not use Glucosa B. Braun 40%:

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 following head trauma.

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 administered this solution, which may lead to brain swelling (encephalopathy).

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

If large amounts of this 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 using Glucosa B. Braun 40%.

Patients must be evaluated 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 blood glucose levels and hyperosmolar syndrome. 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.

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 hypoglycemic states in neonates or young children, less concentrated glucose solutions (10–25%) are recommended.

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

Use of Glucosa B. Braun 40% with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to take any other medicines, especially those 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 used to treat cancer and autoimmune diseases.
• Selective serotonin reuptake inhibitors (SSRIs) used to treat 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 treatment of 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 output).

The use of Glucosa B. Braun 40% 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 additives 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

Consult your doctor or pharmacist before using any 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. Thus, administration should be cautious in pregnant women.

Glucose solutions should be administered with special caution in pregnant women during labor, especially when used 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 40%

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

This medicine will be administered only by healthcare professionals, 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 (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 increase the action of vasopressin, due to the risk of abnormally low sodium levels in the blood (hyponatremia).

Glucosa B. Braun 40% may become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you use more Glucosa B. Braun 40% than you should

This is unlikely to 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, Glucosa B. Braun 40% may produce adverse effects, although not everyone experiences 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 are:

• 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, or burning sensation, or swelling in the infused 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.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through 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 medicines.

If any adverse effect occurs, the infusion should be stopped immediately.

5. Storage of Glucose B. Braun 40%

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

6. Contents of the pack and other information

Composition of Glucose B. Braun 40%

The active substance is Glucose. Each 500 ml container contains 200 g of Glucose (as monohydrate glucose, 440 mg/ml).

Energy value: 1,600 kcal/l

Theoretical osmolarity: 2,220 mOsm/l

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

pH: 3.5 – 5.5

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

Appearance of the product and contents of the pack

Glucose B. Braun 40% is an infusion solution supplied in plastic bottles (Ecoflac plus) 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 summary: October 2019

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

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 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 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.