Patient Information Leaflet

Glucosa B.Braun 70%Infusion Solution

Glucosa B.Braun 70% is a perfusion solution 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 (injection) through a vein.
• preventing or treating low blood sugar (hypoglycemia).
• providing additional fluid to the patient when the body does not have enough water (dehydration).

No use Glucosa B.Braun 70%:

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

If you have:

• high blood glucose levels (hyperglycemia) or elevated blood lactate concentration, 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 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 cerebrovascular accident (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

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 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 grams 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 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.

Newborns, 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 developing severe and potentially fatal cerebral inflammation.

Use with caution in elderly patients or those with liver problems.

Use of Glucosa B.Braun 70% with other medications

Inform your doctor or pharmacist if you are using or 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 the treatment of epilepsy.
• 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.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) for mild to moderate pain relief and to treat body inflammation.
• Desmopressin for treating diabetes insipidus (extreme thirst and continuous production of large volumes of diluted urine).

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

The use of Glucosa B.Braun 70% with other medications may alter the effectiveness of both treatments.

Glucocorticoids, diuretics, diphenylhydantoin, chlorpromazine increase 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.

Administering glucose with digitalis glycosides (digoxin) may cause an increase in digitalis activity, with a risk of developing digitalis intoxication.

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, or plan to become pregnant, consult your doctor or pharmacist before using any medication.

Glucose crosses the placenta, while insulin does not, so the fetus itself is responsible for synthesizing insulin in response to glucose administration. Infusions exceeding 10 g/hour cause increases in fetal insulin. Therefore, it should be administered with caution in pregnant women.

The use of large amounts of glucose solution during childbirth, especially in complicated deliveries, may lead to hyperglycemia (high blood glucose levels), hyperinsulinemia (high insulin levels), hyponatremia, fetal acidosis, and may be harmful to the newborn. Therefore, it should be used with caution during pregnancy.

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. If in 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 requirements, body weight, clinical condition, 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 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 70% may become extremely hypotonic after administration due to glucose metabolism in the body.

If you use more Glucosa B.Braun 70% 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 medicines, this medicine may cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. They may be signs of a severe or even life-threatening allergic reaction:

• 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.

Other side effects are:

• changes in blood chemistry levels (electrolyte imbalances), including:
• • low potassium levels in the blood (hypokalemia).
  • low magnesium levels in the blood (hypomagnesemia).
  • low phosphate levels in the blood (hypophosphatemia).
  • 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 clot area.
  • 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 of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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.

Medicines 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 70% Composition:

• The active ingredient is Glucose. Each 100 ml container contains 70 g of Glucose (as glucose monohydrate, 770 mg/ml).
• The other components (excipients) are hydrochloric acid (pH adjustment) and water for injectable preparations.

Product Appearance and Packaging Contents

Glucose B.Braun 70% is a perfusion solution that is presented in glass bottles of 250 and 500 ml (not all sizes may be marketed).

Marketing Authorization Holder and Responsible Manufacturer

B|BRAUN

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

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 (AEMPS) (http://www.aemps.gob.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 must 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 disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.