PATIENT INFORMATION LEAFLET

Glucosa B. Braun 40% 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 or pharmacist, even if they are not listed in this leaflet. See section 4

6. Contents of the pack and additional information

Glucosa B. Braun 40% is a perfusion 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 through a slow infusion (injection) through a vein.
• preventing or treating low blood sugar (hypoglycemia).

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

No use Glucosa B. Braun 40%:

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

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 fluidification due to excessive fluid addition (hemodilution) and when there is excessive extracellular fluid in the body (hyperhydration).
• severe renal insufficiency (when the kidneys do not function well and dialysis is needed) with anuria (suppression of urine formation).
• after a stroke (hemorrhage).
• low blood volume with hypoxia (oxygen deficiency in the body).
• within the first 24 hours after a head trauma.

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 administered this solution have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to brain 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, irreversible, 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 are at a certain risk of severe and potentially fatal brain inflammation caused by a sudden decrease in blood sodium levels.

If large amounts of the solution need to be administered, more contraindications may appear as high glucose and fluid levels will be preloaded.

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Glucosa B. Braun 40%.

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 may increase the volume of extracellular fluid, 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 pulmonary edema accumulation should be considered, especially in sensitive patients, in cases where the administered fluid volume is very high.

Frequent blood glucose level controls 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.

Administration should be cautious in elderly patients or those with liver problems.

Use ofGlucosa B. Braun 40% withother medications

Inform your doctor or pharmacist if you are using or have recently used other medications or may need to take any other medication,especiallymedications that increase the effect of vasopressin and the risk of low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used for epilepsy treatment.
• 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 40% with other medications may alter the effectiveness of both treatments:

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

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.

Administration of glucose with digitalis glycosides (digoxin) may cause an increase in digitalis activity, with a risk of developing toxicity from these medications.

Your doctor will check the compatibility of this solution with any additives 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 exceeding 10 g/hour cause increases in fetal insulin. Therefore, administration should be cautious in pregnant women

Solutions of glucose should be administered with special caution in pregnant women during childbirth, especially if 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 this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

This medication will be administered by healthcare personnel only, and the dosage will depend on the patient's condition, body weight, clinical situation, and metabolic state. According to individual needs, administer 0.7 to 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 the patient's fluid balance, glucose levels, and electrolyte levels (mainly 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 40% may become extremely hypotonic after administration due to glucose metabolism in the body.

If you use more Glucosa B. Braun 40% 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 excessive water (hyperhydration), excessive 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 medications, Glucosa B. Braun 40% may cause adverse effects, although not everyone will experience them.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist. They may be signs of a severe or even fatal allergic reaction (hypersensitivity):

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

You will be prescribed treatment according to your symptoms.

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

Other adverse effects are:

• high blood sugar levels (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.
• 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 (venous thrombosis) at the infusion site, which causes pain, inflammation, or redness in the area of the clot.
• escape of the infusion solution to the surrounding tissues (extravasation). This may damage the tissues and cause scarring.

• hospital-acquired hyponatremia.
• hyponatremic encephalopathy.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of medications.

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

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging (after CAD). The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the 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.

Glucose B. Braun 40% Composition

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

Nutritional value1.600 kcal/l

Theoretical osmolality2.220 mOsm/l

Acidity (up to pH 7.4)<1,0 mmol/l

pH3.5 – 5.5

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

Product appearance and packaging contents

Glucose B. Braun 40% is a perfusion solution that is presented conditioned in plastic bottles (Ecoflac plus) of 500 ml (may not be marketed in all sizes).

Clinical packaging:10 bottles of 500 ml

Marketing Authorization Holder

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Responsible for manufacturing

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

O

B. BRAUN MELSUNGEN AG

Carl-Braun Strasse, 1

D-34212 Melsungen, Germany

Last review date of this leaflet:October 2019.

For detailed information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for medical professionals or healthcare professionals:

The contents of each container are for a single perfusion. Dispose of the 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.

Before adding medications to the solution or administering simultaneously with other medications, check for any incompatibilities.

These solutions should not be administered through the same infusion equipment that is being used, has been used, or will be used for blood administration, 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.