GLUCOSA B.BRAUN 20% SOLUTION FOR INFUSION

2. What you need to know before you use Glucose B. Braun 20%

Do not use Glucose 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 impairment of glucose tolerance.
• high blood glucose levels (hyperglycemia) or elevated blood lactate levels.
• low potassium or sodium levels in the blood (hypokalemia or hyponatremia).
• edema due to fluid accumulation in tissues.
• hypotonic dehydration (greater loss of salts than water).
• blood dilution due to excessive fluid addition (hemodilution) and when there is excessive fluid in the body's extracellular spaces (extracellular hyperhydration).
• severe renal failure (when the kidneys do not function properly and dialysis is required) with anuria (suppressed urine formation).
• after a cerebrovascular accident (hemorrhage).
• low blood volume with hypoxia (oxygen deficiency in the body).
• during the first 24 hours after a head injury.

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

Warnings and precautions

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 deficits and may increase the volume of fluid outside the cells, causing water intoxication.

Rapid administration of concentrated glucose solutions can cause an increase in 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 grams of glucose.

It should be administered with caution in patients with advanced age or liver problems.

The precautions and warnings related to any added medication should be taken into account.

Patients with critical conditions, pain, postoperative stress, infections, burns, nervous system diseases, cardiac, hepatic, and renal diseases, 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 (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.

Using Glucose B.Braun 20% with other medications

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

The use of Glucose B.Braun 20% with other medications can alter the effectiveness of both treatments:

The administration of glucocorticoids, diuretics, diphenylhydantoin, 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 medications.

If glucose is administered along with digitalis glycosides (digoxin), an increase in digitalis activity may occur, with the risk of developing intoxication from these medications.

Medications 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 medications 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 (medications that increase the amount of urine excreted).

Your doctor will check the compatibility of this solution with any additive before use. 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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medication.

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 newborn. However, it is recommended to use it with caution during this period as well.

3. How to use Glucose B. Braun 20%

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

It will be administered by healthcare personnel only, and the dosage depends on the patient's requirements, body weight, clinical situation, and metabolic state. According to individual needs, administer 0.7 to 4 grams of glucose per kilogram of body weight and day; or up to 0.5 grams of glucose per kilogram of body weight and hour.

Your doctor will monitor the fluid 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 the action of vasopressin due to the risk of abnormally low sodium levels in the blood (hyponatremia).

Glucose B.Braun 20% can become extremely hypotonic after administration due to glucose metabolism in the body.

If you use more Glucose 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, there may be excessive water (hyperhydration), excessive 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, this medicine can cause side effects, although not everybody gets them.

May be signs of a very severe or even 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.

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.

Other side effects are:

• high blood sugar levels (hyperglycemia).
• excessive 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.

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 Medicines and Healthcare Products Agency's website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Glucose B. Braun 20%

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 stated on the packaging. The expiry date is the last day of the month indicated.

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 additional information

Composition of Glucose B.Braun 20%

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

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

Energy value 800 kcal/l

Theoretical osmolarity 1.110 mOsm/l

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

pH 3.5 – 5.5

Appearance of the product and pack contents:

Glucose B.Braun 20% is a solution for infusion presented in 500 ml plastic bottles (Ecoflacplus) (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

O

• 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. http://www.aemps.es.

—————————————————————————————————————

This information is intended for healthcare professionals only:

The contents of each vial are 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 vial must be intact. Do not administer otherwise.

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

Before adding medications to the solution or administering them simultaneously with other medications, 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 medication and all materials that have come into contact with it will be carried out in accordance with local regulations.