GLUCOSA B.BRAUN 50% SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Glucosa B.Braun 50% Solution for Infusion

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Glucosa B.Braun 50% is and what it is used for
2. What you need to know before you use Glucosa B.Braun 50%
3. How to use Glucosa B.Braun 50%
4. Possible side effects
5. Storage of Glucosa B.Braun 50%

Contents of the pack and further information

1. What Glucosa B.Braun 50% is and what it is used for

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

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

• prevent or treat low blood sugar levels (hypoglycemia)

• provide the patient with extra fluid when the body does not have enough water (dehydration).

2. Before using Glucosa B.Braun 50%

Do not use Glucosa B.Braun 50%:

If you have:

• high blood sugar levels (hyperglycemia) or high blood lactate levels or diabetes mellitus or glucose intolerance or diabetic coma.
• low sodium or potassium levels in the blood (hyponatremia or hypokalemia).
• blood dilution due to excessive fluid addition (hemodilution) and when there is too much fluid in the body's extracellular spaces (extracellular hyperhydration).
• severe kidney failure (when the kidneys do not work well and dialysis is needed) with anuria (suppressed urine formation).
• after a stroke (cerebral hemorrhage).
• low blood volume with hypoxia (oxygen deficiency in the body).
• within the first 24 hours after a head injury.

If it is necessary to administer large amounts of the solution, there may be more contraindications since high amounts of glucose and fluids will be pre-infused.

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

Acute hyponatremia can cause acute hyponatremic encephalopathy (brain edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at special risk of suffering severe, irreversible, and potentially fatal brain damage.

Children, women of childbearing age, and patients with severe brain diseases such as meningitis (infection in the membranes surrounding the brain) or brain damage are at certain risk of severe and potentially fatal brain inflammation caused by a sudden decrease in blood sodium levels.

Be careful with Glucosa B.Braun 50%:

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

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

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

Frequent checks 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 hypoglycemic states in neonates 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 added medication should be taken into account.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those bought without a prescription, especially medicines 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.
• Non-steroidal anti-inflammatory drugs to relieve mild to moderate pain and to 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 (medicines that increase the amount of urine excreted).

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

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

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

If glucose is administered together with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with a risk of developing intoxication with these medicines.

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 to be used for blood administration, as there is a possibility of pseudoagglutination.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Glucose crosses the placenta, while insulin does not. The fetus itself is responsible for insulin synthesis in response to glucose administration. Infusions greater than 10 g/hour cause increases in fetal insulin. It should therefore be administered with caution in pregnant women.

Glucose solutions 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 breastfeeding period in the neonate. However, it is recommended to use it with caution during this period as well.

3. How to use Glucosa B.Braun 50%

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

It will be administered by healthcare personnel only, and the dosage depends on the requirements imposed by 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 and day; or up to 0.5 g of glucose per kg of body weight and hour.

Your doctor will monitor the water balance, blood 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 body fluids) and in patients taking medications that increase vasopressin action due to a risk of abnormally low sodium levels in the blood (hyponatremia).

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

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

It is unlikely that this will happen since your doctor will determine your daily doses. However, if you receive an overdose of the medicine, there may be excess water (hyperhydration), excess glucose in the blood (hyperglycemia), alterations in the balance of salts in the blood (hyperosmolarity), which can cause alterations in consciousness, seizures, and coma.

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

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

4. Possible side effects

Like all medicines, Glucosa B.Braun 50% can cause side effects, although not everybody gets them.

You may develop an imbalance in the level of fluids and certain minerals in your body. You may develop low sodium (hyponatremia), potassium, phosphate, and magnesium levels in the blood.

If you experience any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. The following may be signs of a very severe or life-threatening allergic reaction (hypersensitivity):

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

You will be prescribed a treatment according to the symptoms.

Other side effects are:

-

• high blood sugar levels (hyperglycemia).
• excess fluid in the blood vessels (hemodilution and hypervolemia).
• glucose in 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 performed (phlebitis). It can cause redness, pain, or itching or swelling in the infusion vein.
• clot formation (venous thrombosis) at the infusion site, which causes pain, inflammation, or redness in the clot area.
• leakage of the infusion solution into the tissues surrounding the vein (extravasation). This can damage the tissues and cause scarring.
• Hospital hyponatremia.
• Hyponatremic encephalopathy.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucosa B.Braun 50%

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

No special storage conditions are required.

Do not use Glucosa B.Braun 50% after the expiry date which is stated on the carton (after EXP). The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Glucosa B.Braun 50%:

The other ingredients are: hydrochloric acid and water for injectable preparations.

Appearance of the product and pack contents

Glucosa B.Braun 50% is a solution for infusion presented in glass bottles of 500, 1,000 ml (not all pack sizes may be marketed).

Marketing authorization holder and manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

This leaflet was approved in October 2019

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

-------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

The content of each pack is for single infusion only. The unused fraction should be discarded.

The infusion solution should be visually inspected before use. The solution must be transparent, not contain precipitates, and the container must be intact. Do not administer otherwise.

An aseptic procedure should be used to administer the solution and the addition of medicines if necessary.

Before adding medicines to the solution or administering them simultaneously with other medicines, it should be checked that there are no incompatibilities.

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

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