Patient Information Leaflet

Glucosa B. Braun 30% Solution for Infusion

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 if they are not listed in this leaflet. See section 4.

1. What is Glucosa B. Braun 30% and what it is used for

2. What you need to know before using Glucosa B. Braun 30%

3. How to use Glucosa B. Braun 30%

4. Possible side effects

5. Storage of Glucosa B. Braun 30%

6. Contents of the pack and additional information

Glucosa B. Braun 30% 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).

Do not use Glucosa B. Braun 30%:

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 high 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 extracellular fluid in the body (hypervolemia).
• severe kidney insufficiency (when 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 large quantities of the solution need to be administered, more contraindications may appear as you will be preloaded with high amounts of glucose and fluids.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Glucosa B. Braun 30%.

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 may cause potassium, phosphate, or magnesium deficiency and may increase the volume of extracellular fluid, 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 pulmonary edema accumulation should be considered, especially in sensitive patients, in cases where a very high volume of fluid is administered.

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.

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 may lead to cerebral inflammation (encephalopathy).

Acute hyponatremia may cause a hypnatremic 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.

Newborns, 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 a sudden decrease in blood sodium levels.

Administration should be done 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 Glucosa B. Braun 30% with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, especially the following medications 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.
• Non-steroidal anti-inflammatory drugs (NSAIDs) for mild to moderate pain relief and to treat body inflammation.
• Desmopressin for diabetes insipidus (extreme thirst and continuous production of large volumes of diluted urine).

• Oxytocin used during childbirth.
• Vasopressin and terlipressin used for esophageal varices bleeding (dilated veins in the esophagus caused by liver problems).
• Diuretics (medications that increase urine excretion).

The use of Glucosa B. Braun 30% 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.

- If glucose is administered with digitalis glycosides (digoxin), there may be an increase in digitalis activity, and there is a risk of developing digitalis intoxication.

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, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this 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, administration should be done 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.

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 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 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 30% can become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you use more Glucosa B. Braun 30% 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 can manifest with 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, this medicine can cause side 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.

-skin redness (cutaneous erythema).

-hives (urticaria).

You will be prescribed treatment according to the symptoms.

Other side effects are:

-changes in blood chemistry levels (electrolyte imbalances affecting potassium, magnesium, or phosphate) and high blood sugar (hyperglycemia).

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

-sugar in urine (glucosuria).

-chills.

-sweating.

-fever (febrile reaction).

-infection at the injection site.

• hospital-acquired hyponatremia.
• Hyponatremic encephalopathy.

Reactions related to the administration route:

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

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

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

-escape of the perfusion solution to the surrounding tissues (extravasation). This can damage the tissues and cause scarring.

If any side effect occurs, the perfusion should be stopped.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 this medication after the expiration date shown on the packaging (after CAD). 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.

Composition of Glucosa B. Braun 30%:

The active ingredient is Glucose. Each 500 ml container contains 150 g of Glucose (as glucose monohydrate, 330 mg/ml).

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

Appearance of the product and contents of the container

Glucosa B. Braun 30% is a perfusion solution that is presented in plastic bottles (Ecoflac Plus) (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

Last review date of this leaflet: October 2019

Further information on this medicine 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 medical professionals or healthcare professionals:

The contents of each container are for a single perfusion. Discard 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.

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

These solutions must not be administered through the same infusion equipment that is being used, has been used, or will be used for the administration of blood, as there is a possibility of pseudoagglutination.

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