GLUCOSA B.BRAUN 40% SOLUTION FOR INFUSION

2. What you need to know before you use Glucose B. Braun 40%

Do not use Glucose B. Braun 40%:

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

If you have:

• high blood glucose 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).
• fluid overload due to excessive fluid administration (hemodilution) and when there is excessive fluid in the extracellular spaces of the body (extracellular hyperhydration).
• severe kidney failure (when the kidneys do not function properly and dialysis is required) 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.

Patients with critical conditions, pain, postoperative stress, infections, burns, diseases of the nervous system, heart, liver, and kidneys, and patients taking medications that increase the effect of vasopressin (a 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 (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral 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 of the membranes surrounding the brain) or brain damage are at risk of severe and potentially fatal brain inflammation caused by a sudden decrease in blood sodium levels.

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to use Glucose 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 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 cardiovascular system overload (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 patients with advanced age or liver problems.

Use of Glucose B. Braun 40% with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines or if you may need to take any other medicine, especially medicines that increase the effect of vasopressin and the risk of 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 reuptake 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 (excessive 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 Glucose B. Braun 40% with other medicines may alter the effectiveness of both treatments:

The administration of glucocorticoids, diuretics, phenytoin, and 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

Consult your doctor or pharmacist before using 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 Glucose B. Braun 40%

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

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 (mainly sodium) 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).

Glucose B. Braun 40% can become extremely hypotonic after administration due to glucose metabolism in the body.

If you use more Glucose B. Braun 40% 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 an excess of 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. Bring this leaflet with you.

4. Possible side effects

Like all medicines, Glucose B. Braun 40% can cause side effects, although not everybody gets them.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. They can be signs of a very serious and potentially fatal 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 your symptoms.

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

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.
• formation of a blood clot (venous thrombosis) at the infusion site, which causes pain, inflammation, or redness in the area of the clot.
• leakage of the infusion solution into the tissues surrounding the vein (extravasation). This can damage the tissues and cause scarring.

• Hospital hyponatremia.
• Hyponatremic encephalopathy.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of medicines.

If a side effect occurs, the infusion should be stopped.

5. Storage of Glucose B. Braun 40%

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

Composition of Glucose B. Braun 40%

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

Energy value 1,600 kcal/l.

Theoretical osmolality 2,220 mOsm/l.

Acidity (up to pH 7.4) <1.0 mmol/l.

pH 3.5 – 5.5.

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

Appearance of the product and pack contents

Glucose B. Braun 40% is a solution for infusion presented in 500 ml plastic bottles (Ecoflac plus) (not all pack sizes may be marketed).

Clinical pack: 10 bottles of 500 ml.

Marketing authorisation holder

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121.

08191-Rubí (Barcelona).

Spain.

Manufacturer

B|BRAUN

• Braun Medical, S.A.

Ctra. de Terrassa, 121.

08191-Rubí (Barcelona).

Spain.

Or

• BRAUN MELSUNGEN AG.

Carl-Braun Strasse, 1.

D-34212 Melsungen, Germany.

Date of last revision of this leaflet: October 2019.

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

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This information is intended for healthcare professionals only:

The content of each vial is for single use 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 vial 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, or to 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.