Patient Information Leaflet

Glucosa B.Braun 50% Solution for Infusion

Read this leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Glucosa B.Braun 50% is a solution for perfusion used for:

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

• to prevent or treat low blood sugar (hypoglycemia)

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

No use Glucosa B.Braun 50%:

If you have:

• high blood glucose levels (hyperglycemia) or elevated blood lactate concentration (hyperlactatemia) or diabetes mellitus or glucose intolerance or diabetic coma.
• low sodium or potassium blood concentration (hyponatremia or hypokalemia).
• blood dilution due to excessive fluid addition (hemodilution) and when there is excessive fluid in the extracellular spaces of the body (extracellular hyperhydration).
• severe renal insufficiency (when the kidneys do not function well and dialysis is needed) with anuria (suppression of urine formation).
• after a cerebral hemorrhage.
• low blood volume with hypoxia (oxygen deficit in the body).
• within the first 24 hours after a head trauma.

If it is necessary to administer large amounts of the solution, more contraindications may appear since you will be preloaded with high amounts of glucose and fluids..

Patients with critical states, pain, postoperative stress, infections, burns, neurological, cardiac, hepatic, and renal diseases, and patients taking medications that increase the effect of vasopressin (hormone that regulates the amount of body fluids), when this solution is administered, have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to cerebral inflammation (encephalopathy).

Acutely low sodium levels can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, convulsions, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe and potentially fatal brain damage.

Children, fertile women, and patients with severe brain diseases such as meningitis (infection in the membranes surrounding the brain) or brain damage have a certain risk of severe and potentially fatal cerebral inflammation caused by acute low sodium levels in the blood.

Be especially careful with Glucosa B.Braun 50%:

Patients should be evaluated, taking into account the balance of water, ions, and blood glucose. Changes in these values may require appropriate treatment.

Prolonged administration of glucose can cause potassium, phosphate, or magnesium deficiency and can increase the volume of external fluid to cells, causing water intoxication.

Rapid administration of concentrated glucose solutions can cause an increase in blood glucose levels and hyperosmolar syndrome. The risk of cardiovascular system overload (heart and blood circulation) with accumulation of fluid in the lungs (pulmonary edema) should be considered, especially in sensitive patients, in cases where the volume of administered fluid is very high.

Frequent controls of blood glucose levels should be performed, and if necessary, insulin should be administered: one unit for every 10 g of glucose.

For the treatment of hypoglycemia in newborns or young children, the use of less concentrated glucose solutions (10-25%) is recommended.

It should be administered with caution in elderly patients or those with liver problems.

The precautions and warnings related to any medication added to the glucose solution should be taken into account.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, especially medicationsthat increase the effect of vasopressin and the risk of having low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used for the treatment of epilepsy.
• Vincristine and ifosfamide used for cancer treatment.
• Cyclophosphamide for cancer and autoimmune disease treatment.
• Selective serotonin receptor inhibitors (SSRIs) for depression treatment.
• Antipsychotics for mental disorders.
• Opioid analgesics for severe pain relief.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) for mild to moderate pain relief and to treat 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 for treating esophageal varices (dilated veins in the esophagus caused by liver problems).
• Diuretics (medications that increase urine excretion).

The use of Glucosa B.Braun 50% with other medications may alter the effectiveness of both treatments:

The administration of glucocorticoids, diuretics, diphenylhydantoin, and chlorpromazine increases blood glucose levels.

The intravenous administration of glucose in patients treated with insulin or oral antidiabetic medications (biguanides, sulfonylureas) may lead to a reduction in the therapeutic effectiveness of these medications.

If glucose is administered together with digitalis glycosides (digoxin), there is a risk of increased digitalis activity, and the risk of developing digitalis intoxication exists.

Your doctor will check the compatibility of this solution with any additive before using it. These solutions should not be administered with the same infusion equipment used or that will be used for blood administration, as there is a possibility of agglutination.

Pregnancy and lactation:

Consult your doctor or pharmacist before using any medication.

Glucose crosses the placenta, while insulin does not, so the fetus itself is responsible for synthesizing insulin in response to glucose administration.Infusions above 10 g/hour cause increases in fetal insulin.Therefore, it should be administered with caution in pregnant women.

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

On the other hand, there is no evidence to suggest that it may cause adverse effects during the lactation period in the newborn. However, it is recommended to use it with caution during this period.

Follow exactly the administration instructions for Glucosa B.Braun 50% as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

It will be administered by healthcare personnel only and the dosage will depend on the patient's requirements, body weight, clinical condition, and metabolic state. According to individual needs, administer from 0.7 to 4 g of glucose per kg of body weight and day; or up to0.5 gof glucose per kg of body weight and hour.

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

Glucosa B.Braun 50% may become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you use more Glucosa B.Braun 50% than you should

This is unlikely to happen since your doctor will determine your daily doses. However, if you receive an overdose of the medication, you may experience excess water (hyperhydration), excess glucose in the blood (hyperglycemia), alterations in the balance of salts in the blood (hyperosmolarity), which may be accompanied by altered consciousness, seizures, and coma.

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

In case of overdose or accidental ingestion, consult the Toxicological Information Service (phone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

Like all medicines, Glucosa B.Braun 50% may cause side effects, although not everyone will experience them.

You may develop a fluid and electrolyte imbalance in your body. You may develop low levels of sodium (hyponatremia), potassium, phosphate, and magnesium in your blood.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. They may be signs of a severe or even life-threatening allergic reaction:

-inflammation of the skin on your face and lips or inflammation of your throat.

-difficulty breathing.

-skin rash.

-redness of the skin (cutaneous erythema).

-hives (urticaria).

You will be prescribed treatment based on your symptoms.

Other side effects are:

-

-high blood sugar (hyperglycemia).

-excess fluid in your blood vessels (hemodilution and hypervolemia).

-sugar in your urine (glucosuria).

-chills.

-sweating.

-fever (febrile reaction).

-infection at the injection site.

-reactions related to the administration route:

-local reaction or pain (redness or swelling at the infusion site).

-irritation and inflammation of the vein through which the infusion is administered (phlebitis). It may cause redness, pain, or itching or swelling in the infusion vein.

-formation of a blood clot (thrombosis) at the infusion site, which causes pain, inflammation, or redness in the clot area.

-leakage of the infusion solution into the surrounding tissues (extravasation). This may damage the tissues and cause scarring.

• Hospital-acquired hyponatremia.
• Hyponatremic encephalopathy.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use Glucose B.Braun 50% after the expiration date appearing on the packaging (after CAD). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Glucose B.Braun 50%:

The other components are: hydrochloric acid and water for injection preparations.

Appearance of the product and contents of the package

Glucose B.Braun 50% is a perfusion solution that is presented in glass bottles of 500, 1,000 ml (not all sizes may be marketed).

Holder of the marketing authorization and responsible for manufacturing

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This prospectus was approved in October 2019

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es.

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This information is intended solely for doctors or healthcare professionals:

The contents of each package are for a single perfusion. Dispose of any unused portion.

Visually inspect the perfusion solution before use. The solution must be transparent, not contain precipitates, and the container must be intact. Do not administer otherwise.

Use an aseptic procedure to administer the solution and add medications if necessary.

Check for any incompatibilities before adding medications to the solution or administering simultaneously with other medications.

These solutions should not be administered through the same infusion equipment used, used, or to be used for the administration of blood, as there is a possibility of pseudoagglutination.

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