PATIENT INFORMATION LEAFLET

Glucose B.Braun 20% 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 similar symptoms, 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.

Contents of the pack and additional information

Glucosa B.Braun 20% is a perfusion 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 administered through a slow infusion into a vein.
• preventing or treating low blood sugar (hypoglycemia).
• providing additional fluid to the patient when the body does not have enough water (dehydration).
• as a supportive solution to administer other compatible medications.

No use Glucosa B.Braun 20%:

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

If you have:

• Significant alteration of glucose tolerance.
• High glucose levels in the blood (hyperglycemia) or elevated blood lactate concentration (hyperlactatemia).
• Low potassium or sodium levels in the blood (hypokalemia or hyponatremia).
• Edema due to accumulation of fluid in tissues.
• Dehydration with a greater loss of electrolytes than water.
• Fluid overload in the blood due to excessive addition of fluid (hemodilution) and excessive fluid in the extracellular spaces of 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 (deficit of oxygen in the body).
• During the first 24 hours after a head trauma.

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

Warnings and precautions

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

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

Rapid administration of concentrated glucose solutions may cause an increase in blood 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, in cases where a very high volume of fluid is administered.

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

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

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

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) have a certain risk of developing abnormally low sodium levels in the blood (hyponatremia) that may lead to cerebral inflammation (encephalopathy).

Hyponatremia 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 of the membranes surrounding the brain) or brain damage have a certain risk of severe and potentially fatal cerebral inflammation caused by a sudden decrease in sodium levels in the blood.

Use of Glucosa B.Braun 20% with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

The use of Glucosa B.Braun 20% 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 you are given glucose along with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with a risk of developing digitalis intoxication.

Medications that increase the effect of vasopressin and the risk of having low sodium levels (hyponatremia):

• Carbamazepine and oxcarbazepine used to treat epilepsy.
• Vincristine and ifosfamide used to treat cancer.
• Cyclophosphamide to treat cancer and autoimmune diseases.
• Selective serotonin receptor inhibitors (SSRIs) to treat depression.
• Antipsychotics for mental disorders.
• Opioid analgesics to relieve severe pain.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) to relieve mild to moderate pain and treat body inflammation.
• Desmopressin to treat 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).

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

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Glucose crosses the placenta, while insulin does not. 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 done with caution 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.

There is no evidence to suggest that it may cause adverse effects during the lactation period in the neonate. 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. In case of doubt, consult your doctor or pharmacist again.

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 (mainly sodium) levels in the blood before and during treatment, especially in patients with alterations in vasopressin release (hormone that regulates body fluids) 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 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

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 medications, this medication may produce adverse effects, although not everyone will experience them.

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 an imbalance in the level of fluids and certain minerals in your body. You may develop low levels of sodium (hyponatremia), 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 tissues surrounding the vein (extravasation). This may damage the tissues and cause scarring.

• hospital-acquired hyponatremia.
• hyponatremic encephalopathy.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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. The expiration date is the last day of the month indicated.

Medications 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.

Glucose B.Braun 20% Composition

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

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

Nutritional value800 kcal/l

Theoretical osmolality1.110 mOsm/l

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

pH3.5 – 5.5

Product appearance and packaging contents:

Glucose B.Braun 20% is a perfusion solution that is presented in plastic bottles (Ecoflacplus) 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 medication, please visit the website of the Spanish Agency for Medicines and Medical Devices. http://www.aemps.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 any unused portion.

Visually inspect the perfusion solution before use. The solution must be transparent, free of 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 used, used, or to 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.