Leaflet: information for the user

Glucosado Braun 10% solution for infusion

Glucose

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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, even if they are not listed in this leaflet. See section 4.

Glucosado Braun 10% is a perfusion solution (administered intravenously through a drip) with a low concentration of glucose that is used for:

• providing a source of carbohydrates (sugar) alone or, if required, for parenteral nutrition. Parenteral nutrition is used to feed patients who cannot eat. It is performed through a slow infusion (injection) through a vein.
• preventing or treating low blood sugar (moderate hypoglycemia, which causes symptoms but is not fatal).
• providing the patient with additional liquid when the body does not have enough water (dehydration) and you need extra carbohydrates (sugar).
• diluting with water other medications that are desired to be administered intravenously.

Do not use Glucosado Braun 10%if you suffer from any of the following conditions:

• allergy (hypersensitivity) to the active ingredient or to any of the other components of Glucosado Braun 10%.

-uncontrolled diabetes, with blood glucose levels higher than normal (uncontrolled diabetes).

-coma (loss of consciousness) due to hyperosmolar state. This is a type of coma that can occur if you have diabetes and are not receiving adequate medication.

-fluid overload in the blood due to excessive fluid administration (hemodilution) and when there is excessive fluid in the extracellular spaces of the body (extracellular hyperhydration) or increased blood volume in blood vessels than normal (hypovolemia).

-high blood glucose levels (hyperglycemia) or blood lactate concentration higher than normal (hyperlactatemia).

• severe renal insufficiency (when the kidneys do not function properly and dialysis is required) with anuria (suppression of urine formation).
• uncontrolled heart failure.
• low levels of potassium or sodium in the blood (hypokalemia or hyponatremia).
• generalized edema (fluid accumulation under the skin, affecting the entire body, including the brain and lungs).
• liver disease causing fluid accumulation in the abdomen (cirrhosis ascitis).
• after a stroke (hemorrhage).
• within the first 24 hours after a head trauma.
• any other condition that affects the way your body controls blood sugar levels.

If another medication is added to your infusion solution, read the package insert. This will ensure that you can take that medication.

Be especially careful with Glucosado Braun 10%:

Inform your doctor if you have:

• diabetes mellitus. It can be used if adequate treatment with insulin is initiated first.
• renal insufficiency.

-increased intracranial pressure (hypertension intracranial).

-acute ischemic attacks (decreased or absent circulation in arteries).

-acid-base balance alterations.

-malnutrition with vitamin B1 deficiency (essential for glucose metabolism).

Do not administer Glucosado Braun 10% with the same infusion equipment(equipment used to administer medications directly into the blood), either simultaneously or before or after a blood transfusion, as there may be incompatibilities.

Your doctor will regularly monitor your blood sugar levels, electrolyte levels, and fluid balance.

In addition to the glucose solution, your doctor may administer potassium to prevent hypokalemia (low potassium levels in the blood) that may occur during parenteral nutrition.

Continuous administration and in the same infusion site may cause thrombophlebitis (inflammation of the veins).

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 fluid levels in the body), when this solution is administered, have a certain risk of developing abnormally low sodium levels in the blood (acute hyponatremia) that can lead to cerebral inflammation (encephalopathy).

Acutely low sodium levels can cause hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.

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

Older patients will receive special attention, as they may have impaired liver and/or kidney function.

Do not administer by intramuscular route.

Use of other medications

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

It is essential to inform your doctor if you are using any of the following medications:

• Insulin or oral antidiabetic medications (biguanides, sulfonylureas): these medications decrease the effect of glucose.
• Certain hormones (catecholamines) including adrenaline or corticosteroids: due to the risk of increased blood glucose levels.
• Glucosides (digoxin): If intravenous glucose administration coincides with treatment with glucosides (digoxin), there is a risk of developing intoxications with 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.
• Ciclophosphamide to treat cancer and autoimmune diseases.
• Selective serotonin receptor inhibitors (SSRIs) to treat depression.
• Antipsychotics to treat mental disorders.
• Opioid analgesics to relieve severe pain.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) to relieve mild to moderate pain and 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 esophageal varices (dilated veins in the esophagus caused by liver problems).
• Diuretics (medications that increase urine excretion).

Your doctor will check the compatibility of this solution with any additives before using them. These solutions should not be administered with the same infusion equipment used or that will be used for blood transfusions, as there may be agglutination.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

Glucosado Braun 10%can be used safely during pregnancy and lactation. However, your doctor will monitor your body's chemical levels and fluid levels, which should always remain within normal ranges.

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.

However, if another medication is added to the infusion solution during pregnancy or lactation, you should consult your doctor and read the package insert of the medication to be added.

Follow exactly the administration instructions for Glucosado Braun 10% as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

It will be administered by healthcare personnel only, and the dose will depend on the patient's requirements, age, weight, physical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.

Your doctor will monitor the 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).

Glucosado Braun 10% may become extremely hypotonic after administration due to the metabolism of glucose in the body.

If you receive more Glucosado Braun 10% than you should

It is unlikely that this will happen since your doctor will determine your daily doses. However, if you receive an excessive amount of Glucosado Braun 10% (overdose) or if it is administered too quickly or too frequently, the following symptoms may occur:

• dilution of the blood (hemodilution) and excess fluid in the blood vessels (hypervolemia).
• an increase in blood glucose concentration and glucosuria (glucose in urine).
• excessive concentration of certain chemical substances in the blood (hyperosmolarity).
• increase in the amount of urine produced (osmotic diuresis).
• water loss in the body (dehydration).
• imbalance in the levels of salts and acidic and basic substances in the body.

If this happens, the infusion should be stopped immediately and, depending on the severity of the situation, the following should be administered: electrolytes, diuretic medications, or insulin.

If any medication has been added, before the excessive administration, the medication may also cause symptoms. You should read the list of possible symptoms in the prospectus of the added medication.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Glucosado Braun 10% may cause side effects, although not everyone will experience them.

If you consider any of the side effects you are experiencing to be 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 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 your symptoms.

You may develop a fluid and electrolyte imbalance in your body. You may develop low levels of sodium (hyponatremia), potassium, phosphate, and magnesium in your blood.

Other side effects are:

-

-high blood sugar (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 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 tissues surrounding the vein (extravasation). This may damage the tissues and cause scarring.

• hospital-acquired hyponatremia.
• hyponatremic encephalopathy.

Inform your doctor or nurse if you notice any side effect mentioned in this leaflet or not. 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 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 medication.

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

No special storage conditions are required.

Do not use Glucosado Braun 10% after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not use Glucosado Braun 10% if the solution presents turbidity or sedimentation or if the packaging shows visible signs of deterioration.

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.

Composition of Glucosado Braun 10%:

The other components are: water for injection preparations.

Appearance of the product and contents of the packaging:

Glucosado Braun 10% is a perfusion solution that is presented in a low-density polyethylene bottle (Ecoflac Plus®) 100, 250, and 500 ml (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

This prospectus was approved in October 2019.

The detailed information of this medication is available on the website ofthe Spanish Agency of Medicines and Medical Devices.

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This information is intended solely for doctors or healthcare professionals:

The contents of each package are for a single perfusion. Dispose of the 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 should not be administered through the same infusion equipment used, used, or to be used for the administration of blood, as there is a possibility of pseudoagglutination.

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